S-1/A
 

As filed with the Securities and Exchange Commission on July 15, 2005
Registration No. 333-125517
 
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1
to
Form S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
ELECTRO-OPTICAL SCIENCES, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
  3841   13-3986004
(State or other jurisdiction of
incorporation or organization)
  (Primary standard industrial
classification code number)
  (I.R.S. Employer
Identification Number)
3 West Main Street, Suite 201
Irvington, New York 10533
(914) 591-3783
 
(Address, including zip code, and telephone number,
including area code, of registrant’s principal executive offices)
 
Joseph V. Gulfo, M.D.
President and Chief Executive Officer
Electro-Optical Sciences, Inc.
3 West Main Street, Suite 201
Irvington, New York 10533
(914) 591-3783
(Name, address, including zip code, and telephone number, including area code, of agent for service)
 
Copies to:
     
Valerie A. Price, Esq.
Dreier LLP
499 Park Avenue
New York, New York 10022
(212) 328-6144 (phone)
(212) 652-3789 (facsimile)
  David C. Peck, Esq.
Greenberg Traurig, LLP
200 Park Avenue
New York, New York 10166
(212) 801-9200 (phone)
(212) 801-6400 (facsimile)
      Approximate date of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.
      If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”) check the following box.     o
      If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     o
      If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     o
      If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     o
      If delivery of the prospectus is expected to be made pursuant to Rule 434, check the following box.     o
CALCULATION OF REGISTRATION FEE
               
               
               
Title of Each Class of     Proposed Maximum Aggregate     Amount of  
Securities to be Registered     Offering Price(1)     Registration Fee  
               
Common stock, par value $0.001 per share
    $33,000,000     $3,884.10  
               
(1)  Estimated solely for purposes of determining the registration fee pursuant to Rule 457(o) under the Securities Act.
      The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
 
 


 

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer and sale is not permitted.
SUBJECT TO COMPLETION, DATED JULY 15, 2005
PROSPECTUS
(EOS LOGO)
          3,000,000 Shares
Electro-Optical Sciences, Inc.
Common Stock
        This is the initial public offering of 3,000,000 shares of common stock of Electro-Optical Sciences, Inc.
      We expect the public offering price to be between $10.00 and $12.00 per share. There presently is no public market for our securities and we cannot ensure you that a market will develop. We have applied to list our common stock on the NASDAQ National Market under the symbol “MELA.”
       Investing in our common stock is highly speculative and involves a high degree of risk. See “Risk Factors” beginning on Page 7.
 
       Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
 
                 
    Per Share   Total
         
Public offering price
  $       $    
Underwriting discounts and commissions
  $       $    
Proceeds, before expenses, to Electro-Optical Sciences, Inc. 
  $       $    
      To the extent the underwriters sell more than 3,000,000 shares of common stock, the underwriters have the option to purchase up to an additional 450,000 shares from us at the public offering price less the underwriting discount, within 45 days from the date of this prospectus to cover over-allotments. The underwriters will also receive a non-accountable expense allowance in the amount of one percent (1%) of the total public offering price (excluding the over-allotment option). In addition, upon completion of this offering, the underwriters will receive warrants to purchase up to an aggregate of 225,000 shares of our common stock at an exercise price equal to 125% of the public offering price per share. The warrants will be exercisable commencing on the first anniversary of the date of this prospectus and ending on the fifth anniversary of the date of this prospectus.
      The underwriters expect to deliver the shares on or about               , 2005.
Ladenburg Thalmann & Co. Inc. Stanford Group Company
The date of this prospectus is               , 2005.


 

 The MelaFind® System
       PICTURE
MelaFind® is a non-invasive system for assisting in the early detection of melanoma.   The MelaFind® system is comprised of a point-of-care, hand-held imaging device that, in commercial use, is intended to be connected via the internet to a central server located at EOS. When marketed, a report will be transmitted to the physician’s office containing MelaFind®’s recommendation of whether the lesion should be biopsied.
PICTURE
Traditional visual clinical examination is limited to the surface appearance of the suspicious pigmented skin lesion, whereas MelaFind® utilizes information derived from up to 2.5mm deep into the skin. MelaFind® uses an illuminator that shines 10 different specific wavelengths of light (from 430nm to 950nm), including near infra-red bands, which penetrate to varying depths of skin. The data are analyzed against our proprietary database of melanomas and benign lesions using our sophisticated algorithms.


 

TABLE OF CONTENTS
         
Prospectus Summary
    1  
Risk Factors
    7  
Special Note Regarding Forward-Looking Statements
    29  
Use of Proceeds
    30  
Dividend Policy
    30  
Capitalization
    31  
Dilution
    32  
Selected Financial Data
    34  
Management’s Discussion and Analysis of Financial Condition and Results of Operations
    36  
Our Business
    44  
Management
    65  
Related Party Transactions
    75  
Principal Stockholders
    77  
Description of Capital Stock
    79  
Shares Eligible for Future Sale
    83  
Material US Federal Income and Estate Tax Considerations for Non-US Holders
    85  
Underwriting
    88  
Legal Matters
    90  
Experts
    90  
Where You Can Find More Information
    91  
Index to Financial Statements
    F-1  
      You should rely only on the information contained in this prospectus. We have not authorized anyone to provide you with information different from that contained in this prospectus. We are offering to sell shares of our common stock and seeking offers to buy shares of our common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of the common stock.
      For investors outside the US: Neither we nor any of the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the US. You are required to inform yourselves about, and to observe any restrictions relating to, this offering and the distribution of this prospectus.
      We obtained statistical data and certain other industry forecasts used throughout this prospectus from market research, publicly available information and industry publications. Industry publications generally state that they obtain their information from sources that they believe to be reliable, but they do not guarantee the accuracy and completeness of the information. Similarly, while we believe that the statistical and industry data and forecasts and market research used herein are reliable, we have not independently verified such data. We have not sought the consent of the sources to refer to their reports in this prospectus.


 

PROSPECTUS SUMMARY
      This summary highlights information contained elsewhere in this prospectus. It does not contain all of the information you should consider before buying shares of our common stock. You should read this entire prospectus carefully, especially the “Risk Factors” section and our financial statements and the related notes appearing at the end of this prospectus, before deciding to invest in shares of our common stock. Unless otherwise stated or the context otherwise requires, reference in this prospectus to “EOS,” “we,” “us,” “our” and similar references refer to Electro-Optical Sciences, Inc.
Our Business
      We are a medical device company focused on the design and development of a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma. Our flagship product, MelaFind®, features a hand-held imaging device that emits multiple wavelengths of light to capture images of suspicious pigmented skin lesions and extract data. The data are then analyzed against our proprietary database of melanomas and benign lesions using our sophisticated algorithms in order to provide information to the physician and produce a recommendation of whether the lesion should be biopsied.
      The components of the MelaFind® system include:
  •  a hand-held imaging device, which employs high precision optics and multi-spectral illumination (multiple colors of light including near infra-red);
 
  •  our proprietary database of pigmented skin lesions, which we believe to be the largest in the US;
 
  •  our lesion classifiers, which are sophisticated mathematical algorithms that extract lesion feature information and classify lesions; and
 
  •  a central server in our offices that is intended to perform quality control functions and provide reports to the physician and in commercial use, will be connected to physicians’ offices via the internet.
      We have entered into a binding Protocol Agreement with the US Food and Drug Administration (FDA), which is an agreement for the conduct of the pivotal trial in order to establish the safety and effectiveness of MelaFind®. We believe the presence of the Protocol Agreement significantly enhances our ability to expedite the FDA approval process. We stopped a study that was initiated in late 2004 under the Protocol Agreement due to technical difficulties with some of the MelaFind® clinical trial instruments. The FDA has provided confirmation that our plan to correct the technical issues and start a new pivotal trial to satisfy the Protocol Agreement is acceptable. Management estimates that the pivotal trial will commence in early 2006 at over 20 US clinical study sites, and anticipates premarket approval (PMA) to commercialize MelaFind® in 2007.
      To date, we have not generated any revenues from MelaFind®. All of our historical revenues have come from activities and products that have since been discontinued, including our DIFOTI® product, a non-invasive imaging device for the detection of dental cavities. We decided to discontinue all operations associated with our DIFOTI® product, effective as of April 5, 2005, in order to focus our resources on the development and commercialization of MelaFind®.
The Market Opportunity
      Cancer of the skin has a higher incidence than all other cancers combined, and the rates are rising dramatically. In 2005, over 120,000 new cases of melanoma are projected. Melanoma is responsible for approximately 80% of skin cancer fatalities and is the deadliest of all skin cancers as there is currently no cure for advanced stage melanoma. However, early detection of melanoma can lead to virtually a 100% cure rate. Therefore, the need for medical practitioners to be able to examine individuals during a routine annual exam, resulting in early detection and treatment of skin cancer cannot be overstated. Advanced stage melanoma is costly to treat and is responsible for approximately 90% of the total spending on

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melanoma treatment in the US, costing up to $170,000 per patient. If diagnosed early, however, melanoma is almost always cured by simple resection at a cost of approximately $1,800 per patient.
      Melanoma is currently the subject of significant attention in the medical community. In part, this attention is due to the fact that it is the fastest growing cancer. It is also the most common cancer in young adults ages 20-30, and currently there are more new cases of melanoma than HIV/ AIDS. In women ages 25-30, melanoma is the primary cause of cancer death. In women ages 30-35, melanoma is the second leading cause of death after breast cancer. Recent published papers identify a strong correlation between breast cancer and melanoma.
      Because early detection is critical to survival, the American Cancer Society recommends that individuals 40 years and older have complete skin examinations on an annual basis. According to the 2000 US Census data, over 100 million Americans in the US are over age 40. Furthermore, there are more than 20 million individuals in the US who have dysplastic nevi, a type of pigmented skin lesion that when present is associated with an increased risk of melanoma. These individuals warrant more frequent observation.
Limitations of Current Melanoma Diagnosis
      Melanomas are mainly diagnosed by dermatologists and/or primary care physicians using only visual clinical evaluation. Physicians assess pigmented skin lesions using the “ABCDE” criteria, Asymmetry, Border irregularity, Color variation, Diameter greater than 6 mm, and Evolving — change in ABCD over time. This assessment is subjective and results in missed melanomas, as well as a ratio of benign lesions biopsied to melanomas confirmed that is highly variable and as high as 40 to 1 for dermatologists and as high as 50 to 1 for primary care physicians.
      Dermatologists who specialize in the management of pigmented skin lesions may also use dermoscopy, a method of viewing lesions under magnification. Approximately 25% of dermatologists use dermoscopy. Although dermoscopy provides more information than unaided visual examination, mastery of the technique necessitates many years of training and experience. Proper use of dermoscopy can reduce the number of unnecessary biopsies of benign lesions, but even dermoscopy experts biopsy 3-10 benign lesions for every melanoma detected.
      In contrast, MelaFind® delivers an objective assessment based on numerical scores assigned to the suspicious skin lesion under evaluation and does not require extensive physician training to operate. Further, visual clinical evaluation is limited to the surface appearance of the suspicious pigmented skin lesion, whereas MelaFind® utilizes information derived from up to 2.5 mm deep into the skin. In clinical trials to date, this objective assessment has resulted in a ratio of benign lesions biopsied to melanomas confirmed as low as almost 2 to 1.
Clinical Results to Date
      To date, MelaFind® has been studied on over 5,000 skin lesions from over 3,500 patients at over 20 clinical centers. Our clinical studies have demonstrated that MelaFind® missed fewer melanomas and produced fewer false positives than were experienced by study dermatologists, who are skin cancer specialists. The performance of a diagnostic is measured in terms of “sensitivity” (the ability to detect disease when disease is present) and “specificity” (the ability to exclude disease when disease is not present). In the largest blinded trial that we have performed to date on 352 suspicious pigmented skin lesions, MelaFind® did not miss a melanoma (measured sensitivity of 100%) and achieved 48.4% specificity, compared to the study dermatologists’ sensitivity of 96.4% and specificity of 28.4%.
      We believe that with the assistance provided by MelaFind®, physicians could diagnose more melanomas at the earliest, curable stage, which would reduce both treatment costs and the number of unnecessary biopsies, and improve quality of life.

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Our Strategy
      Our objective is for MelaFind® to become an integral part of the standard of care in melanoma detection. To achieve this objective, we are pursuing the following strategy:
  •  Pursue timely FDA approval of MelaFind®: We have entered into a binding Protocol Agreement with the FDA for the conduct of the pivotal trial of MelaFind®. Management estimates that the study will commence in early 2006 at over 20 US clinical study sites, and anticipates PMA approval to commercialize MelaFind® in 2007.
 
  •  Establish MelaFind® as the leading technology for assisting in the detection of melanoma: We have invested considerable capital and expertise into developing our core technology platform, which is protected by six US patents. We will continue to refine and optimize this technology to ensure that MelaFind® is the leading system for assisting in the detection of melanoma.
 
  •  Obtain third party payor reimbursement to support our recurring revenue pricing model: We intend to offer MelaFind® on a per patient basis, creating a recurring revenue stream. To do so, we will seek to obtain third party reimbursement as well as private pay alternatives. We are working with experts to create an evidence-based medicine evaluation model consistent with those used to support positive coverage decisions by the federal Centers for Medicare & Medicaid Services (CMS) and private payors for similar products. The value drivers in the model include the treatment and diagnostic cost savings associated with early detection (approximately $168,000 per patient) and fewer biopsies. We believe that the use of MelaFind® could result in substantial savings to the US healthcare system.
 
  •  Commercialize MelaFind® using multiple sales and marketing strategies: Our sales and marketing effort will focus initially on “high volume/key opinion leader” dermatologists with specialties in the diagnosis and treatment of melanoma. To enter the larger US markets of general dermatologists, plastic surgeons, and primary care physicians, and for international markets, we intend to establish partnerships with pharmaceutical and/or diagnostic device companies with an established presence in these markets. While we believe obtaining a positive coverage decision from CMS may take an additional 18 to 36 months following PMA approval, and obtaining a positive coverage decision from private payors, managed care organizations and state Medicare administrative contractors may take at least 6 to 12 months following PMA approval, we intend to commence sales of MelaFind® immediately upon receiving PMA approval for physicians to offer MelaFind® to their patients on a self-pay basis.
Company Information
      We were incorporated under the laws of the State of New York in 1989 and subsequently reincorporated under the laws of the State of Delaware in 1997. Our executive offices are located at 3 West Main Street, Suite 201, Irvington, New York 10533. Our telephone number is (914) 591-3783. Our websites include www.eo-sciences.com and www.melafind.com. The information contained on our websites is not a part of this prospectus and should not be relied upon. We have included our website addresses in this document as inactive textual references only.
      This prospectus contains references to our US registered trademarks: MelaFind®, DIFOTI®, and the corporate logo for “eos — electro-optical sciences, inc.” All other trademarks, tradenames and service marks appearing in this prospectus are the property of their respective owners.

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THE OFFERING
Common stock offered by us 3,000,000 shares
 
Common stock outstanding after the offering 9,513,164 shares
 
Use of proceeds We estimate that our net proceeds from this offering will be approximately $29.0 million at an assumed initial public offering price of $11.00 per share, which is the mid-point of our filing range, after deducting estimated underwriting discounts and commissions and offering expenses payable by us. We intend to use these net proceeds to fund our research and development activities, including our clinical studies, to build our sales and marketing capabilities, and for general corporate purposes, including working capital needs, facilities expansion and potential acquisitions. See “Use of Proceeds.”
 
Risk factors You should read the “Risk Factors” section of this prospectus for a discussion of factors to consider carefully before deciding to invest in shares of our common stock.
 
Proposed NASDAQ National Market symbol MELA
      The number of shares of our common stock to be outstanding after this offering is based on 6,513,164 shares outstanding as of June 30, 2005, and unless otherwise indicated, excludes:
  •  899,875 shares of common stock issuable as of the date of this prospectus upon the exercise of outstanding stock options under our 2003 Stock Incentive Plan and our 1996 Stock Option Plan, respectively, at a weighted average exercise price of approximately $0.64 per share;
 
  •  up to 1,000,000 shares of common stock reserved for future grants under our 2005 Stock Incentive Plan;
 
  •  75,000 shares of common stock issuable upon exercise of outstanding warrants to purchase common stock at an exercise price of $7.00 per share;
 
  •  73,280 shares of common stock issuable upon exercise of outstanding warrants to purchase our Series C preferred stock (assuming conversion of our Series C preferred stock) at an exercise price of $4.52 per share; and
 
  •  225,000 shares of common stock issuable upon exercise of warrants to be issued to the underwriters upon completion of this offering at an exercise price equal to 125% of the public offering price per share.
      Unless we specifically state otherwise, all information in this prospectus assumes:
  •  that all outstanding shares of our Series A preferred stock, Series B preferred stock and Series C preferred stock are converted into shares of our common stock immediately prior to completion of this offering;
 
  •  that all outstanding warrants to purchase our common stock with an exercise price of $13.00 per share have been exchanged for our common stock based on an exchange rate of one share of common stock for every two shares of common stock purchasable under such warrants in a cashless exchange. See the full discussion in “Related Party Transactions — Warrants to Purchase Common Stock”;
 
  •  no exercise of the underwriters’ over-allotment option;
 
  •  the adoption of our fourth amended and restated certificate of incorporation and third amended and restated bylaws; and
 
  •  a 1-for-2 reverse stock split of our common stock which was approved by our board of directors on May 13, 2005, effective upon the earlier of the conversion of our preferred stock or September 30, 2005.

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SUMMARY FINANCIAL DATA
      The following summary financial data for the fiscal years ended December 31, 2002, 2003 and 2004 have been derived from our historical audited financial statements. The summary financial data for the six month periods ended June 30, 2004 and 2005 have been derived from our unaudited financial statements. The unaudited summary financial data include, in our opinion, all adjustments, consisting only of normal, recurring adjustments, necessary to present fairly the financial position and results of operations for the periods presented. Our historical results for any prior or interim period are not necessarily indicative of results to be expected for a full fiscal year or for any future period. The summary financial data shown below account for the revenues and related expenses for our DIFOTI® product, a non-invasive imaging device for the detection of dental cavities, as a discontinued operation. We decided to discontinue all operations associated with our DIFOTI® product, effective as of April 5, 2005, in order to focus our resources on the development and commercialization of MelaFind®. See the footnote to the Financial Statements relating to discontinued operations and assets held for sale included elsewhere in this prospectus. You should read this information together with our financial statements and the related notes appearing at the end of this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus.
                                           
        Six Months Ended
    Year Ended December 31,   June 30,
         
    2002   2003   2004   2004   2005
                     
                (unaudited)
    (In thousands, except share and per share data)
Statement of Operations Data:
                                       
Revenue from grants
  $ 547     $     $     $     $  
                               
Operating expenses:
                                       
 
Cost of grant revenue
    564                          
 
General and administrative expenses
    511       1,034       1,234       639       996  
 
Research and development
    404       828       1,892       693       1,546  
                               
 
Operating loss from continuing operations
    (932 )     (1,862 )     (3,126 )     (1,332 )     (2,542 )
Interest (income)/expense
    8       76       67       82       (63 )
                               
Loss from continuing operations
    (940 )     (1,938 )     (3,193 )     (1,414 )     (2,479 )
Loss from discontinued operations
    (201 )     (12 )     (426 )     (102 )     (330 )
                               
Net loss
    (1,141 )     (1,950 )     (3,619 )     (1,516 )     (2,809 )
Preferred stock deemed dividends
    214       322       676       243       719  
Preferred stock accretion
    180       25       323       25       842  
Stock distribution of preferred Series B shares
          102                    
                               
Net loss attributable to common stockholders
  $ (1,535 )   $ (2,399 )   $ (4,618 )   $ (1,784 )   $ (4,370 )
                               
Net loss per share, basic and diluted:
                                       
Continuing operations
  $ (0.87 )   $ (1.48 )   $ (2.37 )   $ (0.98 )   $ (2.23 )
Discontinued operations
    (0.13 )     (0.01 )     (0.24 )     (0.06 )     (0.18 )
                               
Basic and diluted net loss per common share
  $ (1.00 )   $ (1.49 )   $ (2.61 )   $ (1.04 )   $ (2.41 )
                               
Basic and diluted weighted average number of shares outstanding
    1,534,760       1,614,897       1,766,608       1,722,743       1,809,758  
                               
Pro forma basic and diluted net loss per common share (unaudited)(1)
                  $ (0.91 )           $ (0.43 )
                               
Pro forma basic and diluted weighted average number of common shares outstanding (unaudited)(1)
                    3,967,024               6,513,164  
                               

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(1)  Pro forma basic and diluted net loss per common share reflects the effect of the assumed conversion of our preferred stock, as if this offering had occurred at the date of original issuance into 3,398,105 shares of our common stock for the year ended December 31, 2004 and six months ended June 30, 2005 which will occur upon closing of this public offering. Additionally, it is assumed that 2,610,643 warrants to purchase the company’s common stock will be exchanged for a total of 1,305,321 shares of our common stock based on an exchange ratio of one share of our common stock for every two shares of our common stock purchasable under the warrants and will occur prior to the closing of this offering. The net loss attributable to our common stockholders used in the computation of basic and diluted net loss per share to compute the unaudited pro forma net loss attributable to common stockholders, has been adjusted to reverse the accretion on our preferred stock and also excludes the preferred stock dividends for the respective period.
      The following table presents summary balance sheet data, derived from our historical audited financial statements, as of December 31, 2003 and December 31, 2004. The table also presents summary balance sheet data, derived from our historical unaudited financial statements, as of June 30, 2005:
  •  On an actual basis; and
 
  •  On an as adjusted basis to give effect to (1) the conversion of all outstanding shares of our convertible preferred stock into an aggregate of 3,398,105 shares of common stock upon the completion of this offering; (2) the exchange of 2,610,643 warrants to purchase the company’s common stock for a total of 1,305,321 shares of our common stock based on an exchange ratio of one share of our common stock for every two shares of our common stock purchaseable under the warrants that is assumed to occur prior to the closing of this offering; and (3) the sale of 3,000,000 shares of common stock in this offering at an assumed initial public offering price of $11.00 per share, after deducting estimated underwriting discounts and commissions and offering expenses paid and payable by us.
                                 
    As of December 31,   As of June 30, 2005
         
    2003   2004    
                Pro Forma
    Actual   Actual   Actual   As Adjusted
                 
            (unaudited)
    (In thousands)
Balance sheet data:
                               
Cash, cash equivalents and marketable securities
  $ 117     $ 6,703     $ 3,794     $ 32,794  
Working capital
    (433 )     6,122       3,480       32,480  
Total assets
    432       7,096       4,997       33,997  
Total liabilities
    650       691       1,245       1,245  
Redeemable convertible preferred stock
    4,067       8,585       9,427        
Total stockholders’ (deficiency)/equity
    (4,285 )     (2,180 )     (5,675 )     32,752  

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RISK FACTORS
      Investing in our common stock involves a high degree of risk. You should carefully consider the following risk factors, as well as the other information in this prospectus, before deciding whether to invest in shares of our common stock. If any of the following risks actually occur, our business, financial condition and results of operations would suffer. In that case, the trading price of our common stock would likely decline and you might lose all or part of your investment in our common stock.
Risks Relating to Our Business
     We currently do not have, and may never develop, any commercialized products.
      We currently do not have any commercialized products or any significant source of revenue. We have invested substantially all of our time and resources over the last five years in developing MelaFind®. MelaFind® will require additional development, clinical evaluation, regulatory approval, significant marketing efforts and substantial additional investment before it can provide us with any revenue. Our efforts may not lead to commercially successful products for a number of reasons, including:
  •  we may not be able to obtain regulatory approvals for MelaFind®, or the approved indication may be narrower than we seek;
 
  •  MelaFind® may not prove to be safe and effective in clinical trials;
 
  •  physicians may not receive any reimbursement from third-party payors, or the level of reimbursement may be insufficient to support widespread adoption of MelaFind®;
 
  •  we may experience delays in our development program;
 
  •  any products that are approved may not be accepted in the marketplace by physicians or patients;
 
  •  we may not have adequate financial or other resources to complete the development and commercialization of MelaFind® or other products;
 
  •  we may not be able to manufacture our products in commercial quantities or at an acceptable cost; and
 
  •  rapid technological change may make our technology and products obsolete.
      We do not expect to be able to commercialize MelaFind® before 2007. If we are unable to develop, obtain regulatory approval for or successfully commercialize MelaFind®, we will be unable to generate revenue.
     We have not received, and may never receive, FDA approval to market MelaFind®.
      We do not have the necessary regulatory approvals to market MelaFind® in the US or in any foreign market. We have not filed, and currently do not have plans to file, for regulatory approval in any foreign market. We plan initially to launch MelaFind®, once approved, in the US. The regulatory approval process for MelaFind® in the US involves, among other things, successfully completing clinical trials and obtaining PMA approval from the FDA. We commenced the PMA application process for MelaFind® by filing a proposed outline for a Modular PMA application (a compilation of well-delineated components submitted separately) on September 30, 2002. The PMA process requires us to prove the safety and effectiveness of MelaFind® to the FDA’s satisfaction. This process is expensive and uncertain, and requires detailed and comprehensive scientific and human clinical data. FDA review may take years after a PMA application is filed. The FDA may never grant approval. The FDA can delay, limit or deny approval of a PMA application for many reasons, including:
  •  MelaFind® may not be safe or effective to the FDA’s satisfaction;
 
  •  the data from our pre-clinical studies and clinical trials may be insufficient to support approval;
 
  •  the manufacturing process or facilities we use may not meet applicable requirements; and

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  •  changes in FDA approval policies or adoption of new regulations may require additional data.
      No precedent has been established for FDA approval of a device such as MelaFind® to assist in determining the appropriateness of biopsies of suspicious pigmented skin lesions. Before submitting a PMA application (the final module), we must successfully complete a pivotal clinical trial to demonstrate that MelaFind® is safe and effective. Product development, including clinical trials, is a long, expensive and uncertain process, and is subject to delays and failure at any stage. Furthermore, the data obtained from the trial may be inadequate to support approval of a PMA application. While we obtained a Protocol Agreement from the FDA, FDA approval of a Protocol Agreement does not mean that the FDA will consider the data gathered in the trial sufficient to support approval of a PMA application, even if the trial’s intended endpoints are achieved. There may be unexpected findings, particularly those that may only become evident from the larger scale of the pivotal clinical trial, as compared with the smaller scale tests done to date. For example, we initiated a clinical trial and encountered several technical problems which required us to refine the MelaFind® system. The data obtained in the pivotal trial may not be sufficient to support the anticipated indication for use, and may not support a more limited indication for use. The occurrence of unexpected findings in connection with the pivotal trial or any subsequent clinical trial required by the FDA may prevent or delay obtaining PMA approval, and may adversely affect coverage or reimbursement determinations. The FDA may also determine that additional clinical trials are necessary, in which case the PMA approval may be delayed for several months or even years while the trials are conducted and the data acquired are submitted in an amendment to the PMA. If we are unable to complete the clinical trials necessary to successfully support the MelaFind® PMA application, our ability to commercialize MelaFind®, and our business, financial condition, and results of operations would be materially adversely affected, thereby threatening our ability to continue operations.
     If MelaFind® is approved by the FDA, it may be approved only for narrow indications.
      Even if approved, MelaFind® may not be approved for the indications that are necessary or desirable for successful commercialization. Our preference is to obtain a broad indication for use in diagnosing almost all pigmented melanomas (other than those on palms, soles of the feet, in or near the eye, and inaccessible areas such as the edge of the nose). The final MelaFind® lesion classifier should be able to identify the maximum number of types of melanoma possible. The indications for use must specify those lesion types for which the classifier has not been trained. Approximately five percent of melanoma lesions may be amelanotic, meaning they are not pigmented. These lesions cannot be differentiated by MelaFind®, which will be restricted to pigmented lesions. Approximately ten percent of pigmented melanoma lesions are nodular, a type of melanoma that is often missed by dermatologists in early stages. If nodular melanoma lesions are not sufficiently well-represented in the MelaFind® training database, the classifier may not differentiate nodular melanomas from non-melanomas with sufficient sensitivity and specificity. If we restrict the indications for use of MelaFind® to exclude certain melanoma lesion types, in addition to the other restrictions, then the size of the market for MelaFind® and the rate of acceptance of MelaFind® by physicians may be adversely affected.
      If we wish to modify MelaFind® after receiving FDA approval, including changes in indications or other modifications that could affect safety and effectiveness, additional approvals could be required from the FDA. We may be required to submit extensive pre-clinical and clinical data, depending on the nature of the changes. Any request by the FDA for additional data, or any requirement by the FDA that we conduct additional clinical studies, could delay the commercialization of MelaFind® and require us to make substantial additional research, development and other expenditures. We may not obtain the necessary regulatory approvals to market MelaFind® in the US or anywhere else. Any delay in, or failure to receive or maintain, approval for MelaFind® could prevent us from generating revenue or achieving profitability, and our business, financial condition, and results of operations would be materially adversely affected.

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      MelaFind® may not be commercially viable if we fail to obtain an adequate level of reimbursement by Medicare and other third party payors. The markets for MelaFind® may also be limited by the indications for which its use may be reimbursed.
      The availability of medical insurance coverage and reimbursement for newly approved medical devices is uncertain. In the US, physicians and other healthcare providers performing biopsies for suspicious skin lesions are generally reimbursed for all or part of the cost of the diagnosis and biopsy by Medicare, Medicaid, or other third-party payors. The commercial success of MelaFind® in both domestic and international markets will significantly depend on whether third-party coverage and reimbursement are available for services involving MelaFind®. Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to contain healthcare costs by limiting both the scope of coverage and the level of reimbursement of new medical devices, and as a result, they may not cover or provide adequate payment for the use of MelaFind®. In order to obtain satisfactory reimbursement arrangements, we may have to agree to a fee or sales price lower than the fee or sales price we might otherwise charge. Even if Medicare and other third-party payors decide to cover procedures involving our product, we cannot be certain that the reimbursement levels will be adequate. Accordingly, even if MelaFind® or future products we develop are approved for commercial sale, unless government and other third-party payors provide adequate coverage and reimbursement for our products, some physicians may be discouraged from using them, and our sales would suffer.
      Medicare reimburses for medical devices in a variety of ways, depending on where and how the device is used. However, Medicare only provides reimbursement if CMS determines that the device should be covered and that the use of the device is consistent with the coverage criteria. A coverage determination can be made at the local level by the Medicare administrative contractor (formerly called carriers and fiscal intermediaries), a private contractor that processes and pays claims on behalf of CMS for the geographic area where the services were rendered, or at the national level by CMS through a national coverage determination. There are new statutory provisions intended to facilitate coverage determinations for new technologies, but it is unclear how these new provisions will be implemented. Coverage presupposes that the device has been cleared or approved by the FDA and further, that the coverage will be no broader than the approved intended uses of the device as approved or cleared by the FDA, but coverage can be narrower. A coverage determination may be so limited that relatively few patients will qualify for a covered use of the device. Should a very narrow coverage determination be made for MelaFind®, it may undermine the commercial viability of MelaFind®.
      Obtaining a coverage determination, whether local or national, is a time-consuming, expensive and highly uncertain proposition, especially for a new technology, and inconsistent local determinations are possible. On average, according to an industry report, Medicare coverage determinations for medical devices lag 15 months to five years or more behind FDA approval for that device. The Medicare statutory framework is also subject to administrative rulings, interpretations and discretion that affect the amount and timing of reimbursement made under Medicare. Medicaid coverage determinations and reimbursement levels are determined on a state by state basis, because Medicaid, unlike Medicare, is administered by the states under a state plan filed with the Secretary of the US Department of Health and Human Services (HHS). Medicaid generally reimburses at lower levels than Medicare. Moreover, Medicaid programs and private insurers are frequently influenced by Medicare coverage determinations.
      Any adverse results in our clinical trials, or difficulties in conducting our clinical trials, could have a material adverse effect on our business.
      Clinical studies in the US have been ongoing for over five years, and we have a Protocol Agreement with the FDA, but we have not conducted the pivotal clinical trial required for PMA approval. We initiated a trial under the terms of the Protocol Agreement at the end of 2004. However, technical operational issues with the systems were experienced, requiring further refinement. We are currently refining the hardware systems and expect to have new systems available in order to start the pivotal clinical trial in early 2006. However, we cannot provide any assurances that we will have these systems available on a timely basis. In addition, the pivotal clinical trial and supporting clinical studies will require

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the involvement of larger numbers of clinical sites than we have previously engaged at any single time, and the recruitment of large numbers of patients. If the clinical sites, which enroll patients on a best efforts basis, do not provide cases at rates anticipated for any reason (such as, for example, lower than forecasted clinical site productivity), we may face delays or may be unable to complete the development of MelaFind®.
     Risk of delay in product development.
      We could encounter delays in our pivotal trial or in obtaining PMA approval because of a number of factors. We will require the receipt of all information specified in our Protocol Agreement on the required number of melanomas before the pivotal clinical trial can be concluded. The MelaFind® classifier will then be utilized to evaluate the lesions acquired during the pivotal trial, and the results will be analyzed to determine if we have achieved the endpoints specified in the Protocol Agreement.
      The final training of the classifier, required to be completed before the classifier is utilized as described above, is expected to take approximately two months. Accordingly, the classifier must be ready for final training two months before the end of the pivotal trial. For the classifier to be ready for final training, approximately 300 melanoma lesions are targeted to have been received. Therefore, in addition to acquiring the melanoma lesions required to complete the pivotal trial (approximately 100), we must have completed the acquisition of approximately 300 training melanoma lesions on schedule. Currently, approximately 225 melanoma lesions are in the training database. The current classifier has been trained on 113 of these melanoma lesions.
      Our schedule for the acquisition of these lesions is based upon the projected numbers of imaging devices to be located at participating sites, the projected productivity of those sites in terms of melanomas and other lesions biopsied per month, and the projected efficiency of the study pathologists in classifying the lesion slides presented for histological analysis (the microscopic examination of excised or biopsied tissue specimens) and reporting their results. If we are unable to produce and maintain a sufficient number of imaging devices at participating sites, if the clinicians do not maintain sufficient productivity, or if the pathologists do not produce reports with sufficient efficiency, then our ability to maintain our schedule will be adversely affected, the start or conclusion of the pivotal trial may be delayed, and the submission of the completed PMA will be delayed.
      To date, the lesion images in the training database have been acquired using first-generation hand-held devices, which also extract data from the lesions that are used by the classifiers. Pre-commercialization hand-held devices are being developed for use in the pivotal trial. If the lesion data obtained with pre-commercialization devices are not consistent with data from the first generation hand-held devices, the classifier will need to be trained solely on lesions imaged using only one or the other generation of hand-held devices. Were this need to arise, significant delay and expense could be incurred, which could jeopardize our ability to complete the development of MelaFind®.
      We have incurred losses for a number of years, and anticipate that we will incur continued losses for the foreseeable future.
      We began operations in December 1989. At that time we provided research services, mostly to US government agencies, on classified projects. We have financed our operations since 1999 primarily through private placements of our equity securities, and have devoted substantially all of our resources to research and development relating to MelaFind®. Our net loss for the six months ended June 30, 2005 was $2.8 million, and as of June 30, 2005, we had an accumulated deficit of approximately $16.7 million. We expect our research and development expenses to increase in connection with our clinical trials and other development activities related to MelaFind®. If we receive PMA approval for MelaFind® from the FDA, we expect to incur significant sales and marketing expenses, and manufacturing expenses. Additionally, if we complete our initial public offering, we expect that our general and administrative expenses will increase due to the additional operational and regulatory burdens applicable to public companies. As a result, we expect to continue to incur significant and increasing operating losses for the foreseeable future.

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These losses, among other things, have had and will continue to have an adverse effect on our stockholders’ equity.
      We expect to operate in a highly competitive market, we may face competition from large, well-established medical device manufacturers with significant resources, and we may not be able to compete effectively.
      We do not know of any product possessing the diagnostic assistance capabilities of MelaFind®. We believe that electro-optical products designed to enhance the visualization and analysis of potential melanomas have been approved or are under development by: Welch Allyn, Inc.; Heine Optotechnik; 3Gen, LLC; Derma Medical Systems, Inc.; Medical High Technologies S.p.A.; ZN Vision Technologies AG; Polartechnics, Ltd.; Astron Clinica, Ltd.; LINOS Photonics, Inc.; and Biomips Engineering. The broader market for precision optical imaging devices used for medical diagnosis is intensely competitive, subject to rapid change, and significantly affected by new product introductions and other market activities of industry participants. If our products are approved for marketing, we will potentially be subject to competition from major optical imaging companies, such as: General Electric Co.; Siemens AG; Bayer AG; Eastman Kodak Company; Welch Allyn, Inc.; Olympus Corporation; Carl Zeiss AG Deutschland; and others, each of which manufactures and markets precision optical imaging products for the medical market, and could decide to develop or acquire a product to compete with MelaFind®. These companies enjoy numerous competitive advantages, including:
  •  significantly greater name recognition;
 
  •  established relations with healthcare professionals, customers and third-party payors;
 
  •  established distribution networks;
 
  •  additional lines of products, and the ability to offer rebates, higher discounts or incentives to gain a competitive advantage;
 
  •  greater experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products, and marketing approved products; and
 
  •  greater financial and human resources for product development, sales and marketing, and patent litigation.
      As a result, we may not be able to compete effectively against these companies or their products.
      Technological breakthroughs in the diagnosis or treatment of melanoma could render MelaFind® obsolete.
      The precision optical imaging field is subject to rapid technological change and product innovation. MelaFind® is based on our proprietary technology, but a number of companies and medical researchers are pursuing new technologies. Companies in the medical device industry with significantly greater financial, technical, research, marketing, sales and distribution and other resources have expertise and interest in the exploitation of computer-aided diagnosis, medical imaging, and other technologies MelaFind® utilizes. Some of these companies are working on potentially competing products or therapies, including confocal microscopy (a type of scanning microscopy for 3-dimensional specimens, which produces blur-free images at various depths), various forms of spectroscopy (a study of the way molecules absorb and emit light), other imaging modalities, and molecular and genetic screening tests. In addition, the National Institutes of Health and other supporters of cancer research are presumptively seeking ways to improve the diagnosis or treatment of melanoma by sponsoring corporate and academic research. There can be no assurance that one or more of these companies will not succeed in developing or marketing technologies and products or services that demonstrate better safety or effectiveness, superior clinical results, greater ease of use or lower cost than MelaFind®, or that such competitors will not succeed in obtaining regulatory approval for introducing or commercializing any such products or services prior to us. FDA approval of a commercially viable alternative to MelaFind® produced by a competitor could significantly reduce market acceptance of

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MelaFind®. Any of the above competitive developments could have a material adverse effect on our business, financial condition, and results of operations. There is no assurance that products, services, or technologies introduced prior to or subsequent to the commercialization of MelaFind® will not render MelaFind® less marketable or obsolete.
      We depend on clinical investigators and clinical sites to enroll patients in our clinical trials and other third parties to manage the trials and to perform related data collection and analysis, and, as a result, we may face costs and delays that are outside of our control.
      We rely on clinical investigators and clinical sites, some of which are private practices, and some of which are research university or government-affiliated, to enroll patients in our clinical trials. We rely on: pathologists and pathology laboratories; a contract research organization to assist in monitoring, collection of data, and ensuring FDA Good Clinical Practices (GCP) are observed at our sites; a consultant biostatistician; and other third parties to manage the trial and to perform related data collection and analysis. However, we may not be able to control the amount and timing of resources that clinical sites and other third parties may devote to our clinical trials. If these clinical investigators and clinical sites fail to enroll a sufficient number of patients in our clinical trials, or if the clinical sites fail to comply adequately with the clinical protocols, we will be unable to complete these trials, which could prevent us from obtaining regulatory approvals for MelaFind®. Our agreements with clinical investigators and clinical sites for clinical testing place substantial responsibilities on these parties and, if these parties fail to perform as expected, our trials could be delayed or terminated. If these clinical investigators, clinical sites or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain are compromised due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for, or successfully commercialize, MelaFind®.
      In addition to the foregoing, our clinical trial may be delayed or halted, or be inadequate to support approval of a PMA application, for numerous other reasons, including, but not limited to, the following:
  •  the FDA, an Institutional Review Board (IRB), or other regulatory authorities place our clinical trial on hold;
 
  •  patients do not enroll in clinical trials at the rate we expect;
 
  •  patient follow-up is not at the rate we expect;
 
  •  IRBs and third-party clinical investigators delay or reject our trial protocol;
 
  •  third-party organizations do not perform data collection and analysis in a timely or accurate manner;
 
  •  regulatory inspections of our clinical trials or manufacturing facilities, among other things, require us to undertake corrective action or suspend or terminate our clinical trials, or invalidate our clinical trials;
 
  •  changes in governmental regulations or administrative actions; and
 
  •  the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness.
      If MelaFind® is approved for reimbursement, we anticipate experiencing significant pressures on pricing.
      Even if Medicare covers a device for certain uses, that does not mean that the level of reimbursement will be sufficient for commercial success. We expect to experience pricing pressures in connection with the commercialization of MelaFind® and our future products due to efforts by private and government-funded payors to reduce or limit the growth of healthcare costs, the increasing influence of health maintenance organizations, and additional legislative proposals to reduce or limit increase in public funding for

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healthcare services. Private payors, including managed care payors, increasingly are demanding discounted fee structures and the assumption by healthcare providers of all or a portion of the financial risk. Efforts to impose greater discounts and more stringent cost controls upon healthcare providers by private and public payors are expected to continue. Payors frequently review their coverage policies for existing and new diagnostic tools and can, sometimes without advance notice, deny or change their coverage policies. Significant limits on the scope of services covered or on reimbursement rates and fees on those services that are covered could have a material adverse effect on our ability to commercialize MelaFind® and therefore, on our liquidity and our business, financial condition, and results of operations.
      In some foreign markets, which we may seek to enter in the future, pricing and profitability of medical devices are subject to government control. In the US, we expect that there will continue to be federal and state proposals for similar controls. Also, the trends toward managed healthcare in the US and proposed legislation intended to control the cost of publicly funded healthcare programs could significantly influence the purchase of healthcare services and products, and may force us to reduce prices for MelaFind® or result in the exclusion of MelaFind® from reimbursement programs.
      MelaFind® may never achieve market acceptance even if we obtain regulatory approvals.
      To date, only those patients who were treated by physicians involved in our clinical trials have been evaluated using MelaFind® and even if we obtain regulatory approval patients with suspicious lesions and physicians evaluating suspicious lesions may not endorse MelaFind®. Physicians tend to be slow to change their diagnostic and medical treatment practices because of perceived liability risks arising from the use of new products and the uncertainty of third party reimbursement. Physicians may not utilize MelaFind® until there is long-term clinical evidence to convince them to alter their existing methods of diagnosing or evaluating suspicious lesions and there are recommendations from prominent physicians that MelaFind® is effective. We cannot predict the speed at which physicians may adopt the use of MelaFind®. If MelaFind® receives the appropriate regulatory approvals but does not achieve an adequate level of acceptance by patients, physicians and healthcare payors, we may not generate significant product revenue and we may not become profitable. The degree of market acceptance of MelaFind® will depend on a number of factors, including:
  •  perceived effectiveness of MelaFind®;
 
  •  convenience of use;
 
  •  cost of the use of MelaFind®;
 
  •  availability and adequacy of third-party coverage or reimbursement;
 
  •  approved indications and product labeling;
 
  •  publicity concerning MelaFind® or competitive products;
 
  •  potential advantages over alternative diagnostic methodologies;
 
  •  introduction and acceptance of competing products or technologies; and
 
  •  extent and success of our sales, marketing and distribution efforts.
      The identification and screening of melanomas is now dominated by visual clinical evaluation, with a minority of dermatologists using dermoscopy. Even if MelaFind® proves to be as effective as visual inspection by an expert dermatologist, and if all approvals are obtained, the success of MelaFind® will depend upon the acceptance by dermatologists and other physicians who perform skin examinations and treat skin disorders, including industry opinion leaders, that the diagnostic information provided by MelaFind® is medically useful and reliable. We will be subject to intense scrutiny before physicians will be comfortable incorporating MelaFind® in their diagnostic approaches. We believe that recommendations by respected physicians will be essential for the development and successful marketing of MelaFind®, and there can be no assurance that any such recommendations will be obtained. To date, the medical community outside the limited circle of certain dermatologists specializing in melanoma has had little

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exposure to us and MelaFind®. Because the medical community is often skeptical of new companies and new technologies, we may be unable to gain access to potential customers in order to demonstrate the operation and effectiveness of MelaFind®. Even if we gain access to potential customers, no assurance can be given that members of the dermatological, or later the general practice, medical community will perceive a need for or accept MelaFind®. In particular, given the potentially fatal consequences of failing to detect melanoma at the early, curable stages, practitioners may remain reluctant to rely upon MelaFind® even after we receive approval from the FDA for marketing the product.
      Any of the foregoing factors, or other currently unforeseen factors, could limit or detract from market acceptance of MelaFind®. Insufficient market acceptance of MelaFind® would have a material adverse effect on our business, financial condition and results of operations.
      We may be unable to complete the development and commercialization of MelaFind® or other products without additional funding.
      We currently believe that our available cash, cash equivalents and marketable securities, together with our net proceeds from this offering, will be sufficient to fund our anticipated levels of operations through mid 2008. However, our operations have consumed substantial amounts of cash for each of the last six years. We expect to continue to spend substantial amounts on research and development, including conducting a clinical trial for MelaFind®. Even before we receive approval to market MelaFind®, we expect to spend significant additional amounts to ready the product for commercial distribution following FDA approval, including development of a direct sales force and expansion of manufacturing capacity. We expect that our cash used by operations will increase significantly in each of the next several years, and should we encounter any material delays or impediments, we may need additional funds to complete the development and commercialization of MelaFind®. Any additional financing may be dilutive to stockholders, or may require us to grant a lender a security interest in our assets. The amount of funding we will need will depend on many factors, including:
  •  the schedule, costs, and results of our clinical trials;
 
  •  the success of our research and development efforts;
 
  •  the costs and timing of regulatory approval;
 
  •  reimbursement amounts for the use of MelaFind® that we are able to obtain from Medicare and third party payors, or the amount of direct payments we are able to obtain from patients and/or physicians utilizing MelaFind®;
 
  •  the cost of commercialization activities, including product marketing and building a domestic direct sales force;
 
  •  the emergence of competing or complementary technological developments;
 
  •  the costs of filing, prosecuting, defending and enforcing any patent claims and other rights, including litigation costs and the results of such litigation;
 
  •  the costs involved in defending any patent infringement actions brought against us by third parties; and
 
  •  our ability to establish and maintain any collaborative, licensing or other arrangements, and the terms and timing of any such arrangements.
      Additional financing may not be available to us when we need it, or it may not be available on favorable terms. If we are unable to obtain adequate financing on a timely basis, we may be required to significantly curtail or cease one or more of our development and marketing programs. We could be required to seek funds through arrangements with collaborators or others that may require us to relinquish rights to some of our technologies, product candidates or products that we would otherwise pursue on our own. We also may have to reduce marketing, customer support and other resources devoted to our products. If we raise additional funds by issuing equity securities, our then-existing stockholders will

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experience ownership dilution, could experience declines in our share price and the terms of any new equity securities may have preferences over our common stock.
      If we are unable to establish sales, marketing and distribution capabilities or enter into and maintain arrangements with third parties to sell, market and distribute MelaFind®, our business may be harmed.
      We do not have a sales organization, and have no experience as a company in the marketing and distribution of devices such as MelaFind®. To achieve commercial success for MelaFind®, we must develop a sales and marketing force and enter into arrangements with others to market and sell our products. Following product approval, we currently plan to establish a small direct sales force to market MelaFind® in the US, focused on introducing it at high volume dermatologists’ offices and training their staff in its use, but we have not made any final determinations regarding the use of a particular marketing channel. Developing such a sales force is expensive and time consuming, and could delay or limit the success of any product launch. We may not be able to develop this capacity on a timely basis or at all. Qualified direct sales personnel with experience in the medical device market are in high demand, and there is no assurance that we will be able to hire or retain an effective direct sales team. Similarly, qualified, independent medical device representatives both within and outside the US are in high demand, and we may not be able to build an effective network for the distribution of our product through such representatives. We have no assurance that we will be able to enter into contracts with representatives on terms acceptable or reasonable to us. Similarly, there is no assurance that we will be able to build an alternate distribution framework, should we attempt to do so.
      We will need to contract with third parties in order to sell and install our products in larger markets, including non-specialist dermatologists and primary care physicians. To the extent that we enter into arrangements with third parties to perform marketing and distribution services in the US, our product revenue could be lower and our costs higher than if we directly marketed MelaFind®. Furthermore, to the extent that we enter into co-promotion or other marketing and sales arrangements with other companies, any revenue received will depend on the skills and efforts of others, and we do not know whether these efforts will be successful. If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, independently or with others, we will not be able to generate product revenue, and may not become profitable.
      We have limited manufacturing capabilities and manufacturing personnel, and if our manufacturing capabilities are insufficient to produce an adequate supply of MelaFind®, our growth could be limited and our business could be harmed.
      We have not yet completed the development and testing of MelaFind®, and as a result have no experience in manufacturing MelaFind® for commercial distribution. We currently have limited resources, facilities and experience to commercially manufacture MelaFind®. In order to produce MelaFind® in the quantities we anticipate to meet market demand, we will need to increase our manufacturing capacity by a significant factor over the current level, or procure manufacturing services from others. There are technical challenges to increasing manufacturing capacity, including equipment design and automation, material procurement, problems with production yields, and quality control and assurance. Developing commercial-scale manufacturing facilities that meet FDA requirements would require the investment of substantial additional funds and the hiring and retaining of additional management and technical personnel who have the necessary manufacturing experience.
      We currently plan to outsource certain production aspects to contract manufacturers. Any difficulties in the ability of third-party manufacturers to supply devices of the quality, at the times, and in the quantities we need, could have a material adverse effect on our business, financial condition, and results of operations. Similarly, if we enter into contracts for third party manufacture of our devices, any revenue received will depend on the skills and efforts of others, and we do not know whether these efforts will be successful. Manufacturers often encounter difficulties in scaling up production of new products, including problems involving product yields, controlling and anticipating product costs, quality control and assurance, component supply, and shortages of qualified personnel. We cannot assure you that the third-party contract

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manufacturers with whom we are developing relationships will have or sustain the ability to produce the quantities of MelaFind® needed for development or commercial sales, or will be willing to do so at prices that allow MelaFind® to compete successfully in the market.
      Assuming that MelaFind® receives regulatory approval, if we are unable to manufacture or obtain a sufficient supply of product, maintain control over expenses, or otherwise adapt to anticipated growth, or if we underestimate growth, we may not have the capability to satisfy market demand, and our business will suffer. Additionally, if MelaFind® receives regulatory approval and we then need to make manufacturing changes, we may need to obtain additional approval for these changes.
      MelaFind® is complex and may contain undetected design defects and errors when first introduced, or errors that may be introduced when enhancements are released. Such defects and errors may occur despite our testing, and may not be discovered until after our devices have been shipped to and used by our customers. The existence of these defects and errors could result in costly repairs, returns of devices, diversion of development resources and damage to our reputation in the marketplace. Any of these conditions could have a material adverse impact on our business, financial condition and results of operations. In addition, if we contract with third-party manufacturers for the production of our products, these manufacturers may inadvertently produce devices that vary from devices we have produced in unpredictable ways that cause adverse consequences.
      Our manufacturing operations are dependent upon third-party suppliers, making us vulnerable to supply problems and price fluctuations, which could harm our business. We anticipate contracting for final device assembly and integration, but no contract for such services on a commercial basis has yet been procured.
      Our manufacturing efforts currently rely on FillFactory, a subsidiary of Cypress Semiconductor Corp., to manufacture and supply the complementary metal oxide semiconductor sensor in MelaFind®, on Pracownia Optyki Instrumentalnej (Optyka) for lens elements and on Fairchild Semiconductor Corp., Panasonic Corp., and others for light-emitting diodes, or LEDs, printed circuit boards, and other elements or components of our devices. We have written agreements with several of these vendors, under which the vendor is obligated to perform services or produce components for us. There can be no assurance that these third parties will meet their obligations under the agreements. Each of these suppliers is a sole-source supplier. Our contract manufacturers also rely on sole-source suppliers to manufacture some of the components used in our products. Our manufacturers and suppliers may encounter problems during manufacturing due to a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction and environmental factors, any of which could delay or impede their ability to meet our demand. Our reliance on these outside manufacturers and suppliers also subjects us to other risks that could harm our business, including:
  •  suppliers may make errors in manufacturing components that could negatively affect the effectiveness or safety of our products, or cause delays in shipment of our products;
 
  •  we may not be able to obtain adequate supply in a timely manner or on commercially reasonable terms;
 
  •  we may have difficulty locating and qualifying alternative suppliers for our sole-source suppliers;
 
  •  switching components may require product redesign and submission to the FDA of a PMA supplement or possibly a separate PMA, either of which could significantly delay production;
 
  •  our suppliers manufacture products for a range of customers, and fluctuations in demand for the products these suppliers manufacture for others may affect their ability to deliver components to us in a timely manner; and
 
  •  our suppliers may encounter financial hardships unrelated to our demand for components, which could inhibit their ability to fulfill our orders and meet our requirements.

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      Any interruption or delay in the supply of components or materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders.
      We have entered into a development agreement with ASKION GmbH (ASKION) to complete developmental engineering and testing of our hand-held imaging device, and have entered into a non-binding Letter of Intent with ASKION to assemble the components and produce initial quantities of our hand-held imaging devices for clinical trials. We intend to enter into a contract for commercial production of the hand-held imaging devices once specifications for MelaFind® have been finalized, but we may not be able to enter such an agreement on mutually acceptable terms. Failure to enter into such an agreement with ASKION would require us to expand our own manufacturing facilities or obtain such services elsewhere. Our planned reliance upon an outside provider for assembly and production services subjects us to the risk of adverse consequences from delays and defects caused by the failure of such outside supplier to meet its contractual obligations. The failure by us or our supplier to produce a sufficient number of hand-held imaging devices that can operate according to our specifications could delay the pivotal clinical trial and/or the commercial sale of MelaFind®, and would adversely affect both our ability to successfully commercialize MelaFind® and our business, financial condition and results of operations.
      We will not be able to sell MelaFind® unless and until its design is verified and validated in accordance with current good manufacturing practices as set forth in the US medical device Quality System Regulation.
      We are in the process, but have not yet successfully completed, all the steps necessary to verify and validate the design of the MelaFind® system that are required to be performed prior to commercialization. If we are delayed or unable to complete verification and validation successfully, we will not be able to sell MelaFind®, and we will not be able to meet our plans for the commercialization of MelaFind® in 2007.
      Assuming that regulatory approval of MelaFind® is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or effectiveness of the device. Later discovery of previously unknown problems with MelaFind®, including manufacturing problems, or failure to comply with regulatory requirements such as the Quality System Regulation (a set of current good manufacturing practice requirements put forth by the FDA which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation and servicing of finished devices) (QSR), may result in restrictions on MelaFind® or its manufacturing processes, withdrawal of MelaFind® from the market, patient or physician notification, voluntary or mandatory recalls, fines, withdrawal of regulatory approvals, refusal to approve pending applications or supplements to approved applications, refusal to permit the import or export of our products, product seizures, injunctions or the imposition of civil or criminal penalties. Should any of these enforcement actions occur, our business, financial condition and results of operations could be materially and adversely affected.
      Assuming that MelaFind® is approved by regulatory authorities, if we or our suppliers fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with MelaFind®, it could be subject to restrictions or withdrawal from the market.
      Any product for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data and promotional activities for such product, will be subject to continuous review and periodic inspections by the FDA and other regulatory bodies. In particular, we and our suppliers are required to comply with the QSR and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage, promotion, distribution, and shipping of MelaFind®, and with record keeping practices. We also will be subject to ongoing FDA requirements, including required submissions of safety and other post-market information and reports and registration and listing requirements. To the extent that we contract with third parties to manufacture some of our products, our manufacturers will be required to adhere to current Good Manufacturing Practices (cGMP) requirements enforced by the FDA as part of QSR, or similar regulations required by regulatory agencies in other countries. The manufacturing facilities of our contract

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manufacturers must be inspected or must have been inspected, and must be in full compliance with cGMP requirements before approval for marketing. The FDA enforces the QSR and other regulatory requirements through unannounced inspections. We have not yet been inspected by the FDA for MelaFind®, and will have to complete such an inspection successfully before we ship any commercial MelaFind® devices. However, we were previously inspected in connection with DIFOTI®, which we have discontinued for business reasons, and were cited for failures to comply fully with QSR mandated procedures. We have discussed the findings in a subsequent meeting with the FDA and are in the process of addressing the deficiencies. The FDA inspectors observed deficiencies that were documented on FDA Form 483 that was issued to us following the inspection. We have had a follow-up meeting with the FDA, and are working with the FDA and consultants to address the inspectional findings, particularly as they relate to current MelaFind® design development and ultimate MelaFind® commercial manufacturing. If we are not successful in convincing the FDA that we are capable of addressing its concerns, or if our efforts to address the deficiencies should prove unsuccessful, we might be subject to additional FDA action of a type described below, which could negatively affect our ability to commercialize MelaFind®.
      There can be no assurance that the future interpretations of legal requirements made by the FDA or other regulatory bodies with possible retroactive effect, or the adoption of new requirements or policies, will not adversely affect us. We may be slow to adapt, or may not be able to adapt to these changes or new requirements. Failure by us or one of our suppliers to comply with statutes and regulations administered by the FDA and other regulatory bodies, or failure to take adequate response to any observations, could result in, among other things, any of the following actions:
  •  warning letters;
 
  •  fines and civil penalties;
 
  •  unanticipated expenditures;
 
  •  delays in approving or refusal to approve MelaFind®;
 
  •  withdrawal of approval by the FDA or other regulatory bodies;
 
  •  product recall or seizure;
 
  •  interruption of production;
 
  •  operating restrictions;
 
  •  injunctions; and
 
  •  criminal prosecution.
      If any of these actions were to occur, it would harm our reputation and cause our product sales and profitability to suffer.
      We are involved in a heavily regulated sector, and our ability to remain viable will depend on favorable government decisions at various points by various agencies.
      From time to time, legislation is introduced in the US Congress that could significantly change the statutory provisions governing the approval, manufacture and marketing of a medical device. Additionally, healthcare is heavily regulated by the federal government, and by state and local governments. The federal laws and regulations affecting healthcare change constantly, thereby increasing the uncertainty and risk associated with any healthcare related venture, including our business and MelaFind®. In addition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance, or interpretations changed, and what the impact of such changes, if any, may be.
      The federal government regulates healthcare through various agencies, including but not limited to the following: (i) the FDA, which administers the Food, Drug, and Cosmetic Act (FD&C Act), as well as other relevant laws; (ii) CMS, which administers the Medicare and Medicaid programs; (iii) the Office of Inspector General (OIG) which enforces various laws aimed at curtailing fraudulent or abusive practices,

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including by way of example, the Anti-Kickback Law, the Anti-Physician Referral Law, commonly referred to as Stark, the Anti-Inducement Law, the Civil Money Penalty Law, and the laws that authorize the OIG to exclude healthcare providers and others from participating in federal healthcare programs; and (iv) the Office of Civil Rights, which administers the privacy aspects of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). All of the aforementioned are agencies within HHS. Healthcare is also provided or regulated, as the case may be, by the Department of Defense through its TriCare program, the Public Health Service within HHS under the Public Health Service Act, the Department of Justice through the Federal False Claims Act and various criminal statutes, and state governments under Medicaid and other state sponsored or funded programs and their internal laws regulating all healthcare activities.
      In addition to regulation by the FDA as a medical device manufacturer, we are subject to general healthcare industry regulations. The healthcare industry is subject to extensive federal, state and local laws and regulations relating to:
  •  billing for services;
 
  •  quality of medical equipment and services;
 
  •  confidentiality, maintenance and security issues associated with medical records and individually identifiable health information;
 
  •  false claims; and
 
  •  labeling products.
      These laws and regulations are extremely complex and, in some cases, still evolving. In many instances, the industry does not have the benefit of significant regulatory or judicial interpretation of these laws and regulations. If our operations are found to be in violation of any of the federal, state or local laws and regulations that govern our activities, we may be subject to the applicable penalty associated with the violation, including civil and criminal penalties, damages, fines or curtailment of our operations. The risk of being found in violation of these laws and regulations is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Any action against us for violation of these laws or regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s time and attention from the operation of our business.
      We must comply with complex statutes prohibiting fraud and abuse, and both we and physicians utilizing MelaFind® could be subject to significant penalties for noncompliance.
      There are extensive federal and state laws and regulations prohibiting fraud and abuse in the healthcare industry that can result in significant criminal and civil penalties. These federal laws include: the anti-kickback statute which prohibits certain business practices and relationships, including the payment or receipt of remuneration for the referral of patients whose care will be paid by Medicare or other federal healthcare programs; the physician self-referral prohibition, commonly referred to as the Stark Law; the anti-inducement law, which prohibits providers from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use items or services covered by either program; the Civil False Claims Act, which prohibits any person from knowingly presenting or causing to be presented false or fraudulent claims for payment by the federal government, including the Medicare and Medicaid programs and; the Civil Monetary Penalties Law, which authorizes HHS to impose civil penalties administratively for fraudulent or abusive acts.
      Sanctions for violating these federal laws include criminal and civil penalties that range from punitive sanctions, damage assessments, money penalties, imprisonment, denial of Medicare and Medicaid payments, or exclusion from the Medicare and Medicaid programs, or both. As federal and state budget pressures continue, federal and state administrative agencies may also continue to escalate investigation and enforcement efforts to root out waste and to control fraud and abuse in governmental healthcare programs. Private enforcement of healthcare fraud has also increased, due in large part to amendments to

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the Civil False Claims Act in 1986 that were designed to encourage private persons to sue on behalf of the government. A violation of any of these federal and state fraud and abuse laws and regulations could have a material adverse effect on our liquidity and financial condition. An investigation into the use of MelaFind® by physicians may dissuade physicians from either purchasing or using MelaFind®, and could have a material adverse effect on our ability to commercialize MelaFind®.
      The application of the privacy provisions of HIPAA is uncertain.
      HIPAA, among other things, protects the privacy and security of individually identifiable health information by limiting its use and disclosure. HIPAA directly regulates “covered entities” (insurers, clearinghouses, and most healthcare providers) and indirectly regulates “business associates” with respect to the privacy of patients’ medical information. All entities that receive and process protected health information are required to adopt certain procedures to safeguard the security of that information. It is uncertain whether we would be deemed to be a covered entity under HIPAA, and it is unlikely that based on our current business model, we would be a business associate. Nevertheless, we will likely be contractually required to physically safeguard the integrity and security of the patient information that we or our physician customers receive, store, create or transmit. If we fail to adhere to our contractual commitments, then our physician customers may be subject to civil monetary penalties, and this could adversely affect our ability to market MelaFind®. We also may be liable under state laws governing the privacy of health information.
      We may become subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages and injunctive relief. Our patents may also be subject to challenge on validity grounds, and our patent applications may be rejected.
      Third parties could, in the future, assert infringement or misappropriation claims against us with respect to our current or future products. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Therefore, we cannot be certain that we have not infringed the intellectual property rights of such third parties. Our potential competitors may assert that some aspect of MelaFind® infringes their patents. Because patent applications may take years to issue, there also may be applications now pending of which we are unaware that may later result in issued patents that MelaFind® infringes. There also may be existing patents of which we are unaware that one or more components of our MelaFind® system may inadvertently infringe.
      Any infringement or misappropriation claim could cause us to incur significant costs, could place significant strain on our financial resources, divert management’s attention from our business and harm our reputation. If the relevant patents were upheld as valid and enforceable and we were found to infringe, we could be prohibited from selling our product that is found to infringe unless we could obtain licenses to use the technology covered by the patent or are able to design around the patent. We may be unable to obtain a license on terms acceptable to us, if at all, and we may not be able to redesign MelaFind® to avoid infringement. A court could also order us to pay compensatory damages for such infringement, plus prejudgment interest and could, in addition, treble the compensatory damages and award attorney fees. These damages could be substantial and could harm our reputation, business, financial condition and operating results. A court also could enter orders that temporarily, preliminarily or permanently enjoin us and our customers from making, using, selling, offering to sell or importing MelaFind®, and/or could enter an order mandating that we undertake certain remedial activities. Depending on the nature of the relief ordered by the court, we could become liable for additional damages to third parties.
      We also may rely on our patents, patent applications and other intellectual property rights to give us a competitive advantage. Whether a patent is valid, or whether a patent application should be granted, is a complex matter of science and law, and therefore we cannot be certain that, if challenged, our patents, patent applications and/or other intellectual property rights would be upheld. If one or more of those

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patents, patent applications and other intellectual property rights are invalidated, rejected or found unenforceable, that could reduce or eliminate any competitive advantage we might otherwise have had.
      New product development in the medical device industry is both costly and labor intensive with very low success rates for successful commercialization; if we cannot successfully develop or obtain future products, our growth would be delayed.
      Our long-term success is dependent, in large part, on the design, development and commercialization of MelaFind® and other new products and services in the medical device industry. The product development process is time-consuming, unpredictable and costly. There can be no assurance that we will be able to develop or acquire new products, successfully complete clinical trials, obtain the necessary regulatory clearances or approvals required from the FDA on a timely basis, or at all, manufacture our potential products in compliance with regulatory requirements or in commercial volumes, or that MelaFind® or other potential products will achieve market acceptance. In addition, changes in regulatory policy for product approval during the period of product development, and regulatory agency review of each submitted new application, may cause delays or rejections. It may be necessary for us to enter into licensing arrangements, in order to market effectively any new products or new indications for existing products. There can be no assurance that we will be successful in entering into such licensing arrangements on terms favorable to us or at all. Failure to develop, obtain necessary regulatory clearances or approvals for, or successfully market potential new products could have a material adverse effect on our business, financial condition and results of operations.
      We face the risk of product liability claims and may not be able to obtain or maintain adequate insurance.
      Our business exposes us to the risk of product liability claims that is inherent in the testing, manufacturing and marketing of medical devices, including those which may arise from the misuse or malfunction of, or design flaws in, our products. We may be subject to product liability claims if MelaFind® causes, or merely appears to have caused, an injury or if a patient alleges that MelaFind® failed to provide appropriate diagnostic information on a lesion where melanoma was subsequently found to be present. Claims may be made by patients, healthcare providers or others involved with MelaFind®. MelaFind® will require PMA approval prior to commercialization in the US. The clinical studies of MelaFind® are considered by the FDA as Non-Significant Risk (NSR). Consequently, the trials are conducted under the auspices of an abbreviated Investigational Device Exemption (IDE). We therefore do not maintain domestic clinical trial liability insurance. We have obtained clinical trial liability insurance in certain European countries where required by statute or clinical site policy. Although we have general liability insurance that we believe is appropriate, and anticipate obtaining adequate product liability insurance before commercialization of MelaFind®, this insurance is and will be subject to deductibles and coverage limitations. Our anticipated product liability insurance may not be available to us in amounts and on acceptable terms, if at all, and if available, the coverages may not be adequate to protect us against any future product liability claims. If we are unable to obtain insurance at an acceptable cost or on acceptable terms with adequate coverage, or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may harm our business. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could result in significant costs and significant harm to our business.
      We may be subject to claims against us even if the apparent injury is due to the actions of others. For example, we rely on the expertise of physicians, nurses and other associated medical personnel to operate MelaFind®. If these medical personnel are not properly trained or are negligent, we may be subjected to liability. These liabilities could prevent or interfere with our product commercialization efforts. Defending a suit, regardless of merit, could be costly, could divert management attention and might result in adverse publicity, which could result in the withdrawal of, or inability to recruit, clinical trial volunteers, or result in reduced acceptance of MelaFind® in the market.

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      Insurance and surety companies have reassessed many aspects of their business and, as a result, may take actions that could negatively affect our business. These actions could include increasing insurance premiums, requiring higher self-insured retentions and deductibles, reducing limits, restricting coverages, imposing exclusions, and refusing to underwrite certain risks and classes of business. Any of these actions may adversely affect our ability to obtain appropriate insurance coverage at reasonable costs, which could have a material adverse effect on our business, financial condition and results of operations.
      We may be adversely affected by a data center failure.
      The success of MelaFind® is dependent upon our ability to protect our data center against damage from fire, power loss, telecommunications failure, natural disaster, sabotage or a similar catastrophic event. Substantially all of our computer equipment and data operations are located in a single facility. Our prospective failure to maintain off-site copies of information contained in our MelaFind® database, or our inability to use alternative sites in the event we experience a natural disaster, hardware or software malfunction or other interruption of our data center, or any interruption in the ability of physicians to obtain access to our MelaFind® server and its database could adversely impact our business, financial condition and results of operations.
      We may be adversely affected by breaches of online security.
      Our MelaFind® database does not contain any information that allows us to identify specific patients. However, we must identify certain data as belonging to or as derived from specific patients for billing purposes. To the extent that our activities involve the storage and transmission of confidential information, security breaches could damage our reputation and expose us to a risk of loss, or to litigation and possible liability. Our business may be materially adversely affected if our security measures do not prevent security breaches. In addition, such information may be subject to HIPAA privacy and security regulations, the potential violation of which may trigger concerns by healthcare providers, which may adversely impact our business, financial condition and results of operations.
      We are dependent upon telecommunications and the internet.
      The connection between the MelaFind® hand-held imaging device and the central server in our offices will be dependent on the internet. Our success will depend in large part on the continued availability of electronic means for storing and transmitting encoded compressed diagnostic information, and storing and transmitting the results of the comparison of such information with our electronically-maintained database through the internet. If the domestic and international telecommunications infrastructure required for these transmissions fails, our business could be materially adversely affected.
      We plan to use the internet as a medium to provide diagnostic assistance services to physicians. We also plan to use the internet to inform the public about the availability of our products and to market to and communicate with physicians who are potential or actual customers. Our success will therefore depend in part on the continued growth and use of the internet. If our ability to use the internet fails, it may materially adversely affect our business.
      We will be obligated to comply with Federal Communications Commission regulations for radio transmissions used by our products.
      Versions of MelaFind® may rely on radio transmissions from the hand-held imaging device to a base station that is connected to the internet. Applicable requirements will restrict us to a particular band of frequencies allocated to low power radio service for transmitting data in support of specific diagnostic or therapeutic functions. Failure to comply with all applicable restrictions on the use of such frequencies, or unforeseeable difficulties with the use of such frequencies, could impede our ability to commercialize MelaFind®.

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      All of our operations are conducted at a single location. Any disruption at our facility could increase our expenses.
      All of our operations are conducted at two adjacent buildings in Irvington, New York. We take precautions to safeguard our facility, including insurance, health and safety protocols, contracted off-site engineering services, provision for off-site manufacturing, and storage of computer data. However, a natural disaster, such as a fire, flood or earthquake, could cause substantial delays in our operations, damage or destroy our manufacturing equipment or inventory, and cause us to incur additional expenses. The insurance we maintain against fires, floods, earthquakes and other natural disasters may not be adequate to cover our losses in any particular case.
      We may be liable for contamination or other harm caused by materials that we handle, and changes in environmental regulations could cause us to incur additional expense.
      Our manufacturing, research and development and clinical processes do not generally involve the handling of potentially harmful biological materials or hazardous materials, but they may occasionally do so. We are subject to federal, state and local laws and regulations governing the use, handling, storage and disposal of hazardous and biological materials. If violations of environmental, health and safety laws occur, we could be held liable for damages, penalties and costs of remedial actions. These expenses or this liability could have a significant negative impact on our business, financial condition and results of operations. We may violate environmental, health and safety laws in the future as a result of human error, equipment failure or other causes. Environmental laws could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We may be subject to potentially conflicting and changing regulatory agendas of political, business and environmental groups. Changes to or restrictions on permitting requirements or processes, hazardous or biological material storage or handling might require an unplanned capital investment or relocation. Failure to comply with new or existing laws or regulations could harm our business, financial condition and results of operations.
      Failure to obtain and maintain regulatory approval in foreign jurisdictions will prevent us from marketing abroad.
      Following commercialization of MelaFind® in the US, we may market MelaFind® internationally. Outside the US, we can market a product only if we receive a marketing authorization and, in some cases, pricing approval, from the appropriate regulatory authorities. The approval procedure varies among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval, in addition to other risks. Foreign regulatory bodies have established varying regulations governing product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. We may not obtain foreign regulatory approvals on a timely basis, if at all. Foreign regulatory agencies, as well as the FDA, periodically inspect manufacturing facilities both in the US and abroad. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. We have not taken any significant actions to obtain foreign regulatory approvals. We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize MelaFind® in any market on a timely basis, or at all. Our inability or failure to comply with varying foreign regulation, or the imposition of new regulations, could restrict our sale of products internationally.
      Our success will depend on our ability to attract and retain our personnel.
      We are highly dependent on our senior management, especially Joseph V. Gulfo, M.D., our President and Chief Executive Officer, and Dina Gutkowicz-Krusin, Ph.D., our Director of Clinical Studies. Our success will depend on our ability to retain our current management and to attract and retain qualified personnel in the future, including scientists, clinicians, engineers and other highly skilled personnel. Competition for senior management personnel, as well as scientists, clinicians, engineers, and experienced

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sales and marketing individuals, is intense, and we may not be able to retain our personnel. The loss of the services of members of our senior management, scientists, clinicians or engineers could prevent the implementation and completion of our objectives, including the development and introduction of MelaFind®. The loss of a member of our senior management or our professional staff would require the remaining executive officers to divert immediate and substantial attention to seeking a replacement. Each of our officers may terminate their employment at any time without notice and without cause or good reason.
      We expect to expand our operations and grow our research and development, product development and administrative operations. This expansion is expected to place a significant strain on our management, and will require hiring a significant number of qualified personnel. Accordingly, recruiting and retaining such personnel in the future will be critical to our success. There is competition from other companies and research and academic institutions for qualified personnel in the areas of our activities. If we fail to identify, attract, retain and motivate these highly skilled personnel, we may be unable to continue our development and commercialization activities.
      Our financial results for future periods may be adversely affected by changes required by financial and accounting regulatory agencies.
      Our reported financial results may be adversely affected by changes in accounting principles generally accepted in the US. Generally accepted accounting principles in the US are subject to interpretation by the Financial Accounting Standards Board (FASB), the American Institute of Certified Public Accountants, the Securities and Exchange Commission (SEC), and various bodies formed to promulgate and interpret appropriate accounting principles. A change in these principles or interpretations could have a significant effect on our reported financial results, and could affect the reporting of transactions completed before the announcement of a change.
      For example, we currently are not required to record stock-based compensation charges if the employee’s stock option exercise price is equal to or exceeds the fair value of our common stock at the date of grant. However, several companies have recently elected to change their accounting policies, and have begun to record the fair value of stock options as an expense. New FASB Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment (FASB Statement No. 123R), requires companies to recognize in the income statement the grant-date fair value of stock options and other equity-based compensation issued to employees. Under FASB Statement No. 123R, SEC registrants would have been required to implement this standard for interim or annual periods beginning after June 15, 2005, or after December 15, 2005 for small business issuers. On April 14, 2005, the SEC adopted a new rule amending the compliance dates for FASB Statement No. 123R. The SEC’s new rule permits companies to implement FASB Statement No. 123R at the beginning of their next fiscal year, instead of the next reporting period that begins after June 15, 2005, or December 15, 2005 for small business issuers. Awards to most non-employee directors will be accounted for as employee awards. All public companies must use either the modified prospective or the modified retrospective transition method. Under the modified prospective method, awards that are granted, modified, or settled after the date of adoption should be measured and accounted for in accordance with FASB Statement No. 123R. Under the modified retrospective method, the previously-reported amounts are restated to either the beginning of the year of adoption or for all periods presented. If we elect to adopt the retroactive provisions and to restate all prior periods presented our operating expenses and reported losses will increase. Although we believe that our accounting practices are consistent with current accounting pronouncements, changes to or interpretations of accounting methods or policies in the future may require us to reclassify, restate or otherwise change or revise our financial statements.
      Our financial results for future periods will be affected by the attainment of milestones.
      We have granted to certain employees stock options that vest with the attainment of various performance milestones. Upon the attainment of these milestones we will be required to recognize a stock based compensation expense in an amount based on the then current fair market value of our common

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stock underlying the options which vest when the milestone is attained. Assuming that all shares offered are sold in this public offering at a price of $11.00 per share, the mid-point of our filing range, that upon the attainment of each of the relevant milestones such offering price remains the fair market value per share of our common stock, and that the number of shares of our common stock outstanding after this offering remains 9,513,164 then we will record a compensation expense: (1) upon completion of this offering of $1,301,570 with respect to 125,000 shares underlying options with an exercise price of $0.46 per share; (2) upon filing our MelaFind® PMA with the FDA of $527,000 with respect to 50,000 shares underlying options with an exercise price of $0.46 per share; and (3) upon our receipt of PMA approval for MelaFind® of $528,000 with respect to 50,000 shares underlying options with a weighted average exercise price of $0.44 per share and of $3,643,667 with respect to 345,699 shares underlying options with an exercise price of $0.46 per share.
If we fail to maintain the adequacy of our internal controls, our ability to provide accurate financial statements could be impaired and any failure to maintain our internal controls and provide accurate financial statements could cause our stock price to decrease substantially.
      We will face increased legal, accounting, administrative and other costs and expenses as a public company that we did not incur as a private company. The Sarbanes-Oxley Act of 2002 (SOX), as well as new rules subsequently implemented by the SEC, the Public Company Accounting Oversight Board and the NASDAQ National Market, require changes in the corporate governance practices of public companies. We expect these new rules and regulations to increase our legal and financial compliance costs, to divert management attention from operations and strategic opportunities, and to make legal, accounting and administrative activities more time-consuming and costly. We also expect to incur substantially higher costs to maintain directors’ and officers’ insurance. We are in the process of instituting changes to our internal procedures to satisfy the requirements of the SOX. We are evaluating our internal controls systems in order to allow us to report on, and our independent registered public accounting firm to attest to, our internal controls, as required by Section 404 of the SOX. While we anticipate being able to fully implement the requirements relating to internal controls and all other aspects of Section 404 of the SOX in a timely fashion, we cannot be certain as to the timing of completion of our evaluation, testing and remediation actions or the impact of the same on our operations, since there is no precedent available by which to measure compliance adequacy. As a small company with limited capital and human resources, we will need to divert management’s time and attention away from our business in order to ensure compliance with these regulatory requirements. As a public company, we will require greater financial resources than we have had as a private company. Implementing these changes may require new information technologies systems, the auditing of our internal controls, and compliance training for our directors, officers and personnel. Such efforts would require a potentially significant expense. If we fail to maintain the adequacy of our internal controls as such standards are modified, supplemented or amended from time to time, we may not be able to provide accurate financial statements and comply with the SOX. Any failure to maintain the adequacy of our internal controls and provide accurate financial statements could cause the trading price of our common stock to decrease substantially.
Risks Relating to this Offering
An active trading market for our common stock may not develop.
      Prior to this offering, there has been no public market for our common stock. Although we are seeking approval for listing of our common stock on the NASDAQ National Market, an active trading market for our shares may never develop or be sustained following this offering. Further, we cannot be certain that the market price of our common stock will not decline below the initial public offering price or below the amount required by Nasdaq to maintain a listing on its National Market. Should we fail to meet the minimum standards established by Nasdaq for its National Market, we could be de-listed, meaning shareholders might be subject to limited liquidity. The initial public offering price for our

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common stock will be determined through negotiations with the underwriters. This initial public offering price may vary from the market price of our common stock after the offering and investors may therefore be unable to sell their common stock at or above the initial public offering price.
Our stock price will be volatile, meaning purchasers of our common stock could incur substantial losses.
      Our stock price is likely to be volatile. The stock market in general and the market for medical technology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at or above the initial public offering price. The following factors, in addition to other risk factors described in this section and general market and economic conditions, may have a significant impact on the market price of our common stock:
  •  results of our research and development efforts and our clinical trials;
 
  •  the timing of regulatory approval for our products;
 
  •  failure of any of our products, if approved, to achieve commercial success;
 
  •  the announcement of new products or product enhancements by us or our competitors;
 
  •  regulatory developments in the US and foreign countries;
 
  •  ability to manufacture our products to commercial standards;
 
  •  developments concerning our clinical collaborators, suppliers or marketing partners;
 
  •  changes in financial estimates or recommendations by securities analysts;
 
  •  public concern over our products;
 
  •  developments or disputes concerning patents or other intellectual property rights;
 
  •  product liability claims and litigation against us or our competitors;
 
  •  the departure of key personnel;
 
  •  the strength of our balance sheet;
 
  •  variations in our financial results or those of companies that are perceived to be similar to us;
 
  •  changes in the structure of and third-party reimbursement in the US and other countries;
 
  •  changes in accounting principles or practices;
 
  •  general economic, industry and market conditions; and
 
  •  future sales of our common stock.
      A decline in the market price of our common stock could cause you to lose some or all of your investment and may adversely impact our ability to attract and retain employees and raise capital. In addition, stockholders may initiate securities class action lawsuits if the market price of our stock drops significantly. Whether or not meritorious, litigation brought against us could result in substantial costs and could divert the time and attention of our management. Our insurance to cover claims of this sort may not be adequate.
      We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.
      We cannot specify with certainty the particular uses of the net proceeds we will receive from this offering. Our management will have broad discretion in the application of the net proceeds, including for any of the purposes described in “Use of Proceeds.” Accordingly, you will have to rely upon the judgment of our management with respect to the use of the proceeds, with only limited information concerning

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management’s specific intentions. Our management may spend a portion or all of the net proceeds from this offering in ways that our stockholders may not desire or that may not yield a favorable return. The failure by our management to apply these funds effectively could harm our business and financial condition. Pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.
      Concentration of ownership among our directors, executive officers, and principal stockholders may prevent new investors from influencing significant corporate decisions.
      Upon closing of this offering, based upon beneficial ownership as of June 30, 2005, our directors, executive officers, holders of more than 5% of our common stock, and their affiliates will, in the aggregate, beneficially own approximately 31% of our outstanding common stock. As a result, these stockholders, subject to any fiduciary duties owed to our other stockholders under Delaware law, will be able to exercise a controlling influence over matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions, and will have significant control over our management and policies. Some of these persons or entities may have interests that are different from yours. For example, these stockholders may support proposals and actions with which you may disagree or which are not in your interests. The concentration of ownership could delay or prevent a change in control of our company or otherwise discourage a potential acquirer from attempting to obtain control of our company, which in turn could reduce the price of our common stock. In addition, these stockholders, some of whom have representatives sitting on our board of directors, could use their voting influence to maintain our existing management and directors in office, delay or prevent changes of control of our company, or support or reject other management and board proposals that are subject to stockholder approval, such as amendments to our employee stock plans and approvals of significant financing transactions.
     If there are substantial sales of our common stock, our stock price could decline.
      If our existing stockholders sell a large number of shares of our common stock or the public market perceives that these sales may occur, the market price of our common stock could decline. Based on shares outstanding on June 30, 2005, upon the closing of this offering, assuming no outstanding options are exercised prior to the closing of this offering, we will have approximately 9,513,164 shares of common stock outstanding. All of the shares offered under this prospectus will be freely tradable without restriction or further registration under the federal securities laws, unless purchased by our affiliates. Taking into consideration the effect of lock-up agreements that will be entered into by our stockholders, we estimate that the remaining 6,513,164 shares outstanding upon the closing of this initial public offering will be available for sale pursuant to Rules 144 and 701, and the volume, manner of sale and other limitations under these rules, as follows:
  •  approximately 6,386,000 shares of common stock will be eligible for sale in the public market, beginning 270 days after the effective date of this prospectus, unless the lock-up period is otherwise extended pursuant to its terms; and
 
  •  the remaining approximately 128,000 shares of common stock will become eligible for sale in the public market after October 26, 2005.
      Existing stockholders holding an aggregate of 5,090,001 shares of common stock (including shares of our common stock purchasable pursuant to warrants to purchase our common stock) based on shares outstanding as of June 30, 2005 have rights with respect to the registration of these shares of common stock with the SEC. See “Description of Capital Stock — Registration Rights.” If we register these shares of common stock, they can immediately sell those shares in the public market.
      Within nine months following this offering, we intend to register up to 1,899,875 shares of common stock that are authorized for issuance under our stock option plans. As of June 30, 2005, 899,875 shares were subject to outstanding options, of which 446,675 shares were vested. Once we register these shares, they can be freely sold in the public market upon issuance, subject to the lock-up agreements referred to above and restrictions on our affiliates.

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     You will incur immediate and substantial dilution as a result of this offering.
      The initial public offering price is substantially higher than the book value per share of our common stock. As a result, purchasers in this offering will experience immediate and substantial dilution of $7.56 per share in the tangible book value of our common stock from the initial public offering price, based on the number of shares outstanding as of June 30, 2005. This is due in large part to earlier investors in the company having paid substantially less than the initial public offering price when they purchased their shares. Investors who purchase shares of common stock in this offering will contribute approximately 62% of the total amount we have raised to fund our operations but will own only approximately 32% of our common stock, based on the number of shares outstanding as of June 30, 2005. In addition, the exercise of currently outstanding options and warrants to purchase common stock and future equity issuances, including future public or private securities offerings and any additional shares issued in connection with acquisitions, will result in further dilution.
      Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable and could also limit the market price of our stock.
      Upon the closing of this offering, provisions of our restated certificate of incorporation and bylaws and applicable provisions of Delaware law may make it more difficult for or prevent a third party from acquiring control of us without the approval of our board of directors. These provisions:
  •  set limitations on the removal of directors;
 
  •  limit who may call a special meeting of stockholders;
 
  •  establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings;
 
  •  do not permit cumulative voting in the election of our directors, which would otherwise permit less than a majority of stockholders to elect directors;
 
  •  prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; and
 
  •  provide our board of directors the ability to designate the terms of and issue a new series of preferred stock without stockholder approval.
      In addition, Section 203 of the Delaware General Corporation Law generally limits our ability to engage in any business combination with certain persons who own 15% or more of our outstanding voting stock or any of our associates or affiliates who at any time in the past three years have owned 15% or more of our outstanding voting stock. These provisions may have the effect of entrenching our management team and may deprive you of the opportunity to sell your shares to potential acquirors at a premium over prevailing prices. This potential inability to obtain a control premium could reduce the price of our common stock.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
      This prospectus contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this prospectus regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations stated in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus, particularly in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Additional risks, uncertainties and factors, other than those discussed under “Risk Factors,” could also cause our actual results to differ materially from those projected in any forward-looking statements we make. We operate in a very competitive and rapidly changing environment in which new risks emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume any obligation to update or revise any forward-looking statements, or to so update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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USE OF PROCEEDS
      We estimate that we will receive net proceeds of approximately $29.0 million from our sale of 3,000,000 shares of common stock at an assumed initial public offering price of $11.00 per share, the mid-point of our filing range, after deducting underwriting discounts and commissions and estimated expenses of approximately $4.0 million, which includes our underwriter’s non-accountable expense allowance, legal, accounting, printing costs and expenses, and various fees associated with the registration and listing of our securities payable by us. If the underwriters exercise their over-allotment option in full, we will receive an additional $4,603,500 after deducting $346,500 for underwriting discounts and commissions.
      We intend to use these net proceeds approximately as follows:
  •  60% ($17.4 million) to fund our research and development activities, including our clinical studies;
 
  •  22% ($6.4 million) to develop our sales and marketing capabilities; and
 
  •  18% ($5.2 million) for general corporate purposes, including working capital, and capital expenditures made in the ordinary course of business.
      The amounts that we actually expend for working capital purposes will vary significantly depending on a number of factors. As a result, we will retain broad discretion in the allocation of the net proceeds of this offering. While we have no present understandings, commitments or agreements to enter into any potential acquisitions, we may also use a portion of the net proceeds for the acquisition of, or investment in, technologies or products that complement our business. Pending the uses described above, we intend to invest the net proceeds of this offering in short-term, investment-grade, interest-bearing securities. We cannot predict whether the proceeds which we invest will yield a favorable return.
DIVIDEND POLICY
      We have never declared or paid cash dividends on our common stock. We currently intend to retain our cash for the development of our business. We do not intend to pay cash dividends to our stockholders in the foreseeable future.
      Any future determination relating to our dividend policy will be made at the discretion of our board of directors and will depend on then existing conditions, including our earnings, financial condition, results of operations, level of indebtedness, contractual restrictions, capital requirements, business prospects and other factors our board of directors may deem relevant. Our board of directors’ ability to declare a dividend is also subject to limits imposed by Delaware law.

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CAPITALIZATION
      You should read this capitalization table together with the sections of this prospectus entitled “Management’s Discussions and Analysis of Financial Condition and Results of Operations” and with the financial statements and related notes to those statements included elsewhere in this prospectus.
      The following table sets forth our capitalization as of June 30, 2005:
  •  on an actual basis; and
 
  •  on a pro forma as adjusted basis to reflect the conversion of all our outstanding shares of convertible preferred stock into shares of common stock immediately prior to completion of this offering, the assumed conversion of 2,610,643 warrants to purchase the company’s common stock to be exchanged for a total of 1,305,321 shares of the company’s common stock based on an exchange ratio of one share of our common stock for every two shares of our common stock purchasable under the warrants to occur prior to the closing of this offering and the receipt of the estimated net proceeds from the sale of 3,000,000 shares of our common stock in this offering at the assumed initial public offering price of $11.00 per share, the mid-point of our filing range, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.
                   
    As of June 30, 2005
     
        Pro Forma(1)
        As Adjusted
    Actual   (unaudited)
         
    (In thousands, except share
    and per share data)
Redeemable Convertible Preferred Stock:
               
Redeemable Preferred Stock Series B convertible; 992,986 shares designated (liquidation preference $2.26 per share); issued and outstanding 992,986 shares at December 31, 2003 and 2004 and June 30, 2005 and 0 shares at June 30, 2005, pro forma as adjusted
  $ 2,244        
             
Redeemable Preferred Stock Series C convertible 5,744,340 shares designated (liquidation preference $2.26 per share); issued and outstanding 907,077 shares at December 31, 2003 and 5,414,779 shares at December 31, 2004 and June 30, 2005 and 0 shares at June 30, 2005, pro forma as adjusted
    7,183        
             
Stockholders’ (Deficiency) Equity:
               
Preferred stock — $.10 par value; authorized 16,936,704 shares:
               
 
Series A Convertible Preferred Stock, 199,380 shares designated (liquidation preference $5.00 per share); issued and outstanding 198,000 shares at December 31, 2003 and 2004 and June 30, 2005 and 0 shares at June 30, 2005, pro forma as adjusted
    972        
Common stock — $.001 par value; authorized 30,000,000 shares; issued and outstanding 1,684,760 shares at December 31, 2003 and 1,809,758 shares at December 31, 2004 and June 30, 2005 and 9,513,164 shares at June 30, 2005, pro forma as adjusted
    2       10  
Additional paid-in capital
    10,210       49,601  
Deferred compensation
    (143 )     (143 )
Accumulated deficit
    (16,716 )     (16,716 )
             
Stockholders’ (Deficiency) Equity
    (5,675 )     32,752  
             
Total Capitalization
  $ 3,752       32,752  
             
      None of the columns shown above reflect the following:
  •  899,875 shares of common stock issuable as of the date of this prospectus upon the exercise of outstanding stock options under our 2003 Stock Incentive Plan and our 1996 Stock Option Plan,

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  respectively, at a weighted average exercise price of approximately $0.64 per share”;
 
  •  up to 1,000,000 shares of common stock reserved for future grants under our 2005 Stock Incentive Plan;
 
  •  75,000 shares of common stock issuable upon exercise of outstanding warrants to purchase our common stock at an exercise price of $7.00 per share;
 
  •  73,280 shares of common stock issuable upon exercise of outstanding warrants to purchase our Series C preferred stock (assuming conversion of our Series C preferred stock) at an exercise price of $4.52 per share; and
 
  •  225,000 shares of common stock issuable upon exercise of warrants to be issued to the underwriters upon completion of this offering at an exercise price equal to 125% of the public offering price per share.
 
(1)  Excludes the impact of 125,000 options that vest upon consummation of the offering, which will have no effect on total stockholders’ equity but will require an expense of $1,301,570 to be recorded if such options vested at the assumed initial public offering price of $11.00 per share, which is the mid-point of our filing range.
DILUTION
      If you invest in our common stock, your interest will be diluted to the extent of the difference between the public offering price per share of our common stock and the net tangible book value per share of our common stock immediately after this offering. Net tangible book value per share represents the amount of our common stockholders’ equity, less intangible assets, divided by the number of shares of our common stock outstanding. As of June 30, 2005, we had a net tangible book value of approximately $(5,675,314) or $(3.14) per share of common stock. Pro forma net tangible book value as of June 30, 2005 is $3,751,758 or $0.58 per common share. Assuming the sale by us of 3,000,000 shares of common stock offered in this offering at an assumed initial public offering price of $11.00 per share, the mid-point of our filing range, and after deducting the underwriting discounts and commissions and estimated offering expenses, our as adjusted pro forma net tangible book value as of June 30, 2005, would have been $32,751,758, or $3.44 per share of common stock. This represents an immediate increase in pro forma net tangible book value of $2.86 per share of common stock to our existing stockholders and an immediate dilution of $7.56 per share to the new investors purchasing shares in this offering. The following table illustrates this per share dilution:
         
Assumed initial public offering price per share
  $ 11.00  
Net tangible book value per share as of June 30, 2005
  $ (3.14 )
Pro forma net tangible book value per share as of June 30, 2005
  $ 0.58  
Increase in pro forma net tangible book value per share attributable to new investors
  $ 2.86  
Pro forma net tangible book value per share after the offering
  $ 3.44  
Dilution per share to new investors
  $ 7.56  
      The following table sets forth on a pro forma as adjusted basis, as of June 30, 2005, the number of shares of common stock purchased from us (assuming conversion of all preferred stock into common stock), the total consideration paid and the average price per share paid by existing holders of common stock (assuming conversion of all preferred stock into common stock) and by the new investors in this

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initial public offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by us.
                                         
            Average
    Shares Purchased   Total Consideration   Consideration
             
    Number   Percent   Amount   Percent   Per Share
                     
Existing Investors
    6,513,164       68.5 %   $ 20,033,573       37.8 %   $ 3.08  
New Investors
    3,000,000       31.5       33,000,000       62.2       11.00  
                               
Total
    9,513,164       100.0 %   $ 53,033,573       100.0 %        
      Assuming all our outstanding options and the outstanding warrants are fully exercised, the shares purchased by the new investors would constitute 28.4% of all shares purchased from us, and the total consideration paid by new investors would constitute 60.5% of the total consideration paid for all shares purchased from us. In addition, the average price per share paid by new investors would be $11.00, and the average price per share paid by existing stockholders would be $3.08.
      If the underwriters exercise their over-allotment in full, the following will occur:
  •  The pro forma as adjusted percentage of shares of our common stock held by existing stockholders will decrease to approximately 65.4% of the total number of pro forma as adjusted shares of our common stock outstanding after this offering; and
 
  •  The pro forma as adjusted number of shares of our common stock held by new public investors will increase to 3,450,000, or approximately 34.6% of the total pro forma as adjusted number of shares of our common stock outstanding after this offering.
      In addition, upon completion of this offering, the underwriters will receive warrants to purchase up to an aggregate of 225,000 shares of our common stock at an exercise price equal to 125% of the public offering price per share. The warrants will be exercisable commencing on the first anniversary of the date of this prospectus and ending on the fifth anniversary of the date of this prospectus.
      In the preceding tables, the shares of our common stock exclude, as of June 30, 2005:
  •  899,875 shares of common stock issuable as of the date of this prospectus upon the exercise of outstanding stock options under our 2003 Stock Incentive Plan and our 1996 Stock Option Plan, respectively, at a weighted average exercise price of approximately $0.64 per share;
 
  •  up to 1,000,000 shares of common stock reserved for future grants under our 2005 Stock Incentive Plan;
 
  •  75,000 shares of common stock issuable upon exercise of outstanding warrants to purchase common stock at an exercise price of $7.00 per share;
 
  •  73,280 shares of common stock issuable upon exercise of outstanding warrants to purchase our Series C preferred stock (assuming conversion of our Series C preferred stock) at an exercise price of $4.52 per share; and
 
  •  225,000 shares of common stock issuable upon exercise of warrants to be issued to the underwriters upon completion of this offering at an exercise price equal to 125% of the public offering price per share.

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SELECTED FINANCIAL DATA
      The following summary financial data for the fiscal years ended December 31, 2000, 2001, 2002, 2003 and 2004 have been derived from our historical audited financial statements. The summary financial data for the six months periods ended June 30, 2004 and 2005 have been derived from our unaudited financial statements. The unaudited summary financial data include, in our opinion, all adjustments, consisting only of normal, recurring adjustments, necessary to present fairly the financial position and results of operations for the periods presented. Our historical results for and prior or interim period are not necessarily indicative of results to be expected for a full fiscal year or for any future period. The selected financial data shown below accounts for the revenues and related expenses for our DIFOTI® product, a non-invasive imaging device for the detection of dental cavities, as a discontinued operation. We decided to discontinue all operations associated with our DIFOTI® product, effective as of April 5, 2005, in order to focus our resources and attention on the development and commercialization of MelaFind®. See the footnote to the Financial Statements relating to discontinued operations and assets held for sale included elsewhere in this prospectus. You should read the following selected financial information together with the financial statements and the related notes appearing at the end of this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this prospectus.
                                                         
        Six Months Ended
    Year Ended December 31,   June 30,
         
    2000   2001   2002   2003   2004   2004   2005
                             
                        (unaudited)
    (In thousands, except share and per share data)
Statements of Operations Data:
                                                       
Revenue from grants
  $ 210     $ 290     $ 547     $     $     $     $  
                                           
Cost of grant revenue
    248       193       564                          
General and administrative expenses
    1,061       2,563       511       1,034       1,234       639       996  
Research and development
    726       144       404       828       1,892       693       1,546  
                                           
Operating loss from continuing operations
    (1,825 )     (2,610 )     (932 )     (1,862 )     (3,126 )     (1,332 )     (2,542 )
Interest (income)/expense
    (79 )     (85 )     8       76       67       82       (63 )
                                           
Loss from continuing operations
    (1,746 )     (2,525 )     (940 )     (1,938 )     (3,193 )     (1,414 )     (2,479 )
Loss from discontinued operations
    (534 )     (343 )     (201 )     (12 )     (426 )     (102 )     (330 )
                                           
Net loss
    (2,280 )     (2,868 )     (1,141 )     (1,950 )     (3,619 )     (1,516 )     (2,809 )
Preferred stock deemed dividends
    85       213       214       322       676       243       719  
Preferred stock accretion
    143       180       180       25       323       25       842  
Stock distribution of preferred Series B shares
                      102                    
                                           
Net loss attributable to common stockholders
  $ (2,508 )   $ (3,261 )   $ (1,535 )   $ (2,399 )   $ (4,618 )   $ (1,784 )   $ (4,370 )
                                           
Net loss per share, basic and diluted:
                                                       
Continuing operations
  $ (1.29 )   $ (1.90 )   $ (0.87 )   $ (1.48 )   $ (2.37 )   $ (0.98 )   $ (2.23 )
Discontinued operations
    (0.35 )     (0.23 )     (0.13 )     (0.01 )     (0.24 )     (0.06 )     (0.18 )
                                           
Basic and diluted net loss per common share
  $ $(1.64 )   $ (2.13 )   $ (1.00 )   $ (1.49 )   $ (2.61 )   $ (1.04 )   $ (2.41 )
                                           
Basic and diluted weighted average number of shares outstanding
    1,529,471       1,534,760       1,534,760       1,614,897       1,766,608       1,722,743       1,809,758  
                                           
Pro forma basic and diluted net loss per common share (unaudited)(1)
                                  $ (0.91 )           $ (0.43 )
                                           
Pro forma basic and diluted weighted average number of common shares outstanding (unaudited)(1)
                                    3,967,024               6,513,164  
                                           

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(1)  Pro forma basic and diluted net loss per common share reflects the effect of the assumed conversion of the company’s preferred stock, as if this offering had occurred at the date of original issuance, into 3,398,105 shares of our common stock for the year ended December 31, 2004 and six months ended June 30, 2005 which will occur upon closing of this offering. Additionally, it is assumed that 2,610,643 warrants to purchase the Company’s common stock will be exchanged for a total of 1,305,321 shares of the company’s common stock based on an exchange ratio of one share of our common stock for every two shares of our common stock purchaseable under the warrants and will occur prior to the closing of this offering. The net loss attributable to our common stockholders used in the computation of basic and diluted net loss per share for the unaudited pro forma net loss attributable to common stockholders has been adjusted to reverse the accretion on our preferred stock and also excludes the preferred stock dividends for the respective period.
      The following table presents summary balance sheet data, derived from our historical audited financial statements. The table also presents summary balance sheet, derived from our historical unaudited financial statements, as of June 30, 2004 and June 30, 2005:
                                                         
    As of December 31,   As of June 30,
         
    2000   2001   2002   2003   2004   2004   2005
                             
                        (unaudited)
    (In thousands, except share and per share data)
Balance Sheet Data:
                                                       
Total current assets
  $ 3,513     $ 867     $ 111     $ 217     $ 6,813     $ 877     $ 4,726  
Total assets
    3,814       1,131       344       432       7,096       1,086       4,997  
Total liabilities
    211       247       529       650       691       1,571       1,246  
Redeemable convertible preferred stock
    2,058       2,155       2,244       4,067       8,585       5,167       9,427  
Accumulated deficit
    (4,148 )     (7,197 )     (8,518 )     (10,288 )     (13,907 )     (11,804 )     (16,716 )
Total stockholders’ (deficiency)/equity
    (498 )     (3,408 )     (4,657 )     (4,285 )     (2,180 )     (5,652 )     (5,675 )

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
      You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes appearing at the end of this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” section of this prospectus for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
      We are a medical device company focused on the design and development of a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma. Our flagship product, MelaFind® features a hand-held imaging device that emits multiple wavelengths of light to capture images of suspicious pigmented skin lesions and extract data. We currently do not have any commercialized products or any significant source of revenue; however, the financial results for all periods discussed below account for the revenues and the related expenses associated with our DIFOTI® product, a non-invasive imaging device for the detection of dental cavities, as a discontinued operation. We decided to discontinue all operations associated with our DIFOTI® product effective as of April 5, 2005, in order to focus our resources and attention on the development and commercialization of MelaFind®. We are currently seeking an acquirer for the DIFOTI® assets, and we do not expect to have any significant continuing responsibility for the DIFOTI® business after its disposition. Unless otherwise indicated, the following discussion relates to our continuing operations.
      Our revenue for the foreseeable future will depend on the commercialization of MelaFind® and may vary substantially from year to year and quarter to quarter. Our operating expenses may also vary substantially from year to year and quarter to quarter based on the timing of the clinical trial and patient enrollment. We believe that period-to-period comparisons of our results of operations are not meaningful and should not be relied on as indicative of our future performance.
      We commenced operations in December 1989 as a New York corporation and re-incorporated as a Delaware corporation in September 1997. Since our inception, we have generated significant losses. As of June 30, 2005, we had an accumulated deficit of $16.7 million. We expect to continue to spend significant amounts on the development of MelaFind®. We expect to incur significant commercialization costs when we begin to introduce MelaFind® into the US market. Accordingly, we will need to generate significant revenues to achieve and then maintain profitability.
      Most of our expenditures to date have been for research and development activities and general and administrative expenses. Research and development expenses represent costs incurred for product development, clinical trials and activities relating to regulatory filings and manufacturing development efforts. We expense all of our research and development costs as they are incurred.
      Our research and development expenses incurred through June 30, 2005 were expenses related primarily to the development of MelaFind®. We expect to incur additional research and development expenses relating to MelaFind® prior to its commercial launch in the US and selected markets outside the US. These additional expenses are subject to the risks and uncertainties associated with clinical trials and the FDA regulatory review and approval process. As a result, these additional expenses could exceed our estimated amounts, possibly materially.
      General and administrative expenses consist primarily of salaries and related expenses, general corporate activities and costs associated with our efforts to obtain PMA approval for MelaFind® and building a commercial infrastructure to market and sell MelaFind®. We anticipate that general and administrative expenses will increase as a result of the expected expansion of our operations, facilities and

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other activities associated with the planned expansion of our business, together with the additional costs associated with operating as a public company. We expect selling, general and administrative expenses to increase as we build our sales force and marketing capabilities to support placing MelaFind® in selected markets.
      At December 31, 2004 and June 30, 2005, we had available a net operating loss carry forward for federal income tax reporting purposes of approximately $12.2 million and $15.0 million, respectively. The net operating loss carry forward may be available to offset future taxable income expiring at various dates through the year 2025. The Company’s ability to utilize its net operating losses may be significantly limited due to changes in the company’s ownership as defined by federal income tax regulations.
Critical Accounting Policies and Significant Judgments and Estimates
      Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the US. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our judgments related to accounting estimates. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
      While our significant accounting policies are more fully described in Note 1 to our financial statements appearing at the end of this prospectus, we believe that the following accounting policies and significant judgments and estimates relating to revenue recognition, stock-based compensation charges, and accrued expenses are most critical to aid you in fully understanding and evaluating our reported financial results.
Revenue Recognition
      We decided to discontinue all operations associated with our DIFOTI® product effective as of April 5, 2005, and account for the DIFOTI® revenue and expenses as a discontinued operation. Revenue from the DIFOTI® product sales had been recognized at the time of delivery and acceptance, after consideration of all the terms and conditions of the customer contract. The DIFOTI® products which were being sold prior to December 31, 2004 included a 30-day return policy. Revenue on these products was recognized after the shipment was made and the 30-day return period had elapsed. DIFOTI® products sold subsequent to December 31, 2004 were sold without a right of return and revenue was therefore recognized after the shipment was made. Deferred revenues at each respective balance sheet date consisted of revenues that were billed or paid in advance of the shipment of the product.
      We currently do not have any commercialized products or any significant source of revenue.
Stock-Based Compensation
      We account for non-employee stock-based awards in which goods or services are the consideration received for the equity instruments issued based on the fair value of the equity instruments issued in accordance with the Emerging Issues Task Force Issue No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction With Selling, Goods or Services.”
      We account for stock-based compensation to employees under the intrinsic-value-based method of accounting prescribed by Accounting Principles Board (APB) Opinion No. 25, “Accounting for Stock Issued to Employees,” and disclose the effect of the differences which would result had we applied the fair-value-based method of accounting, on a pro forma basis, as required by FASB Statement No. 123,

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“Accounting for Stock-Based Compensation, as amended by Statement of Financial Accounting Standards (SFAS) No. 148, Accounting for Stock-Based Compensation, Transition and Disclosure.” In December 2004, FASB issued FASB Statement No. 123R, which addresses the accounting for share-based awards to employees and requires companies to recognize the fair value of stock options and other stock-based compensation to employees in their statement of operations. Because we currently account for our stock-based compensation plans in accordance with APB Opinion No. 25, the adoption of FASB Statement No. 123R will have a material effect on our financial statements in future accounting periods.
      Our common stock has not been publicly traded and the determination of the fair value of our common stock involves considerable judgment. In making this determination, we evaluated, among other things, our common stock transactions, the pricing of private equity sales, the rights and preferences of the security being valued, current market conditions, and company specific operational milestones.
      During the twelve months ended June 30, 2005, we used two different fair values for our common stock in determining recorded compensation expense for stock options and warrants granted to employees, non-employee directors, and consultants. For the period July 2004 through September 2004, the fair value of our common stock as determined by management took into consideration market, income, and asset based approaches to valuation as set forth in the AICPA Audit and Accounting Practice Aid for “Valuation of Privately Held Company Equity Securities Issued as Compensation.” We relied most heavily on the income approach utilizing a discounted cash flow method and also utilized the value derived from the market approach. The weighted value range of our common stock for this period was determined to be $0.78 to $1.38 per share and we concluded the fair value was $1.10 per share.
      During the fourth quarter of 2004, the fair value of our common stock as determined by management increased from $1.10 per share to $4.00. This change in valuation from the third quarter 2004 to the fourth quarter 2004 reflected the operational progress as noted below.
      During October 2004, we completed the second private placement of Series C preferred stock units for gross proceeds of $8.1 million at a price of $2.26 per unit (the post reverse split common stock equivalent value was $4.52 per unit). Each unit consisted of one share of Series C preferred stock and one warrant to purchase one share of common stock at an exercise price of $13.00 per share. Since no additional consideration was received for the warrant, the consideration for the preferred stock was less than $2.26 per share. Approximately 35% of the Series C preferred stock units were acquired by new unaffiliated investors. The common stock warrants attached to this issuance were valued at approximately $1.48 per warrant using the Black-Scholes model with a fair value of $4.00 per share of our common stock.
      During October 2004, we received a binding Protocol Agreement from the FDA defining the endpoints of the pivotal clinical trial for MelaFind® approval. We believe that the presence of a Protocol Agreement significantly enhances our ability to expedite the FDA approval process. To support our future growth and the commercialization of MelaFind®, our board of directors approved in December 2004, the appointment of key executives. In addition, our board of directors approved the issuance of 75,000 warrants to Allen & Co. to purchase common stock with an exercise price of $7.00 per share in exchange for financing advice, acknowledging the need for additional capital to support MelaFind® development. The fair value of the Allen & Co. warrant was determined to be $1.60 per warrant using the Black-Scholes method with the following assumptions: common stock value per share $4.00, warrant life of 5 years, a risk-free interest rate of 3.67%, and an expected volatility of 60%. For these reasons, we believe the fair value of our common stock during this period was $4.00 per common share, and accordingly the valuation of options and warrants issued during December 2004 was based upon the $4.00 per share common stock value.
      During the first quarter of 2005, we encountered operational issues and management believes these difficulties negatively impacted the fair value of our common stock for this period. Specifically, a study that was initiated in late 2004 under the Protocol Agreement was stopped due to technical difficulties with some of the MelaFind® clinical trial instruments. In addition, we were inspected by the FDA in connection with its DIFOTI® product in March 2005, and we were cited in a FDA Form 483 for failures to comply fully with the FDA’s QSR. Since no equity transactions were consummated during this period, we did not determine a new estimated fair value of our common stock during this calendar quarter.

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      During the second quarter of 2005, progress was made in addressing the issues that we encountered during the first quarter of 2005. With respect to the MelaFind® clinical instruments, we engaged a consultant to direct the MelaFind® product development efforts and oversee the manufacturing process. In addition, we entered into an agreement with ASKION, a precision optics specialty manufacturer, to develop methods for optimizing the design of the MelaFind® hardware. We provided a report to the FDA outlining our plan to address the technical difficulties with the MelaFind® instruments through a design modification and optimization process with ASKION. On June 30, 2005, we received written confirmation from the FDA that our plan is acceptable. These pre-commercialization instruments will be assembled by ASKION and are expected to be available for the pivotal trial we estimate will commence in early 2006.
      We decided to discontinue all operations associated with our DIFOTI® product effective as of April 5, 2005, in order to focus our resources and attention on the development and commercialization of MelaFind®. We are currently seeking an acquirer for the DIFOTI® assets, and we do not expect to have any significant continuing responsibility for the DIFOTI® business after its disposition. In addition, the inspectional findings identified in the FDA Form 483 were discussed in a subsequent meeting with the FDA on April 28, 2005 and did not result in a product recall. We are in the process of addressing the deficiencies noted.
      Based on our operational progress during the second quarter of 2005, we determined, in consultation with our underwriters, the fair value of our common stock for our proposed initial public offering to be in the range of $10.00 to $12.00 per share.
      In May 2005, we amended stock option agreements for 125,000 shares of our common stock in the aggregate, of three key employees to immediately vest upon the completion of this offering. We will record a charge to operations in the amount of $1.3 million.
      We have granted to certain employees stock options that vest with the attainment of various performance milestones. Upon the attainment of these milestones, we will be required to recognize a stock based compensation expense in an amount based on the then current market value of our common stock underlying the options which vest when the milestone is attained. Assuming that all shares offered are sold in this public offering at a price of $11.00 per share, the mid-point of our filing range, that upon the attainment of each of the relevant milestones such offering price remains the fair market value per share of our common stock, that the number of shares of our common stock outstanding after this offering remains 9,513,164, then we will record a compensation expense upon filing our MelaFind® PMA with the FDA of $0.5 million with respect to 50,000 shares underlying options, and upon our receipt of PMA approval for MelaFind® of $0.5 million with respect to 50,000 shares underlying options. The employment agreement with Dr. Gulfo includes three separate grants of common stock options. The first two stock option grants for a total of 81,753 shares of our common stock have fully vested. The number of shares of our common stock subject to the third stock option can only be calculated at the time of PMA approval of MelaFind®. The number of shares under this option is equal to that number of shares of our common stock equal to four percent of our fully diluted capital stock at the time of PMA approval of MelaFind® minus the 81,753 options granted to Dr. Gulfo under the employment agreement. Assuming that 9,513,164 shares are outstanding as of the completion of this offering and remain the total number of shares outstanding on the date we receive PMA approval, the number of shares subject to this option would be 345,699. This third stock option grant vests 50% at the time of PMA approval of MelaFind®, and the remaining 50% vest in four equal installments over the one year period following such PMA approval of MelaFind®. We will recognize compensation expense in the amount of $3.6 million over the vesting periods.
Accrued Expenses
      As part of the process of preparing financial statements, we are required to estimate accrued expenses. This process involves identifying services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for such service where we have not been invoiced or

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otherwise notified of the actual cost. This is done as of each balance sheet date in our financial statements. Examples of estimated accrued expenses include:
  •  professional service fees;
 
  •  contract clinical service fees;
 
  •  fees paid to contract manufacturers in conjunction with the production of clinical components or materials; and
 
  •  fees paid to third party data collection organizations and investigators in conjunction with the clinical trials.
      In connection with such service fees, our estimates are most affected by our projections of the timing of services provided relative to the actual level of services incurred by such service providers. The majority of our service providers invoice us monthly in arrears for services performed. In the event that we do not identify certain costs that have begun to be incurred or we under or over estimate the level of services performed or the costs of such services, our actual expenses could differ from such estimates. The date on which certain services commence, the level of services performed on or before a given date, and the cost of such services are often subjective determinations. We make these judgments based upon the facts and circumstances known to us in accordance with accounting principles generally accepted in the US.
Results of Operations (in thousands)
Six Months Ended June 30, 2005 Compared to Six Months Ended June 30, 2004 (Unaudited)
      Research and Development Expense. Research and development expense increased by $853 to $1,546 for the six months ended June 30, 2005 from $693 for the six months ended June 30, 2004. Of this increase, $410 was attributable to higher personnel and personnel related costs as we increased headcount to support our research and development programs and $418 relates to increased consulting and outside research fees for the development of our MelaFind® product.
      General and Administrative Expense. General and administrative expense increased by $357 to $996 for the six months ended June 30, 2005 from $639 for the six months ended June 30, 2004. The increase is primarily due to higher personnel and personnel related costs of $140 associated with the addition of key management positions, $44 related to rent and moving expenses on the additional office space, share-based compensation expense of $86, and general office related expenses of $79.
      Interest (Income)/Expense. Interest (income)/ expense for the six months ended June 30, 2005 was ($63) compared to $82 for the corresponding period in 2004. The increase in income for the six months ended June 30, 2005 was due to the higher average cash, cash equivalents and marketable securities balance compared to the prior year period. The interest expense for the six months ended June 30, 2004 principally relates to an imputed interest charge of $80 in connection with financings from related parties.
Year Ended December 31, 2004 Compared to Year Ended December 31, 2003
      Research and Development Expense. Research and development expenses increased by $1,064, from $828 for the year ended December 31, 2003 to $1,892 for the year ended December 31, 2004. This increase relates to increased headcount to support our research and development programs in the amount of $715, and $332 represents increased consulting and outside research fees related to the development of MelaFind®. For the year ended December 31, 2004 research and development costs were approximately 60% of total operating expenses. Clinical and regulatory expense, a component of research and development expense totaled approximately $797 for the year ended December 31, 2004. We expect our research and development expenses to increase in connection with our clinical trials and other development activities as we advance our MelaFind® pivotal study and complete the PMA regulatory approval process.
      General and Administrative Expense. General and administrative expenses increased by $200, to $1,234 for the year ended December 31, 2004 from $1,034 for the year ended December 31, 2003. The increase was principally attributable to $150 in stock-based compensation to non-employee board members, an increase in personnel costs of $63, MelaFind® reimbursement and pre-marketing costs of $69, offset in part by lower consulting fees of $82. For the year ended December 31, 2004, general and administrative

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expenses were approximately 40% of total operating expenses. We expect that our general and administrative expenses will increase to support the additional costs associated with being a public company. In the future, we will also incur selling and marketing expenses to support the commercialization of MelaFind®.
      Interest (Income)/ Expense. Interest (income)/ expense for the year ended December 31, 2004 was $67 compared to $76 for the corresponding period in 2003. The decrease was due principally to higher interest income in 2004 associated with a higher average cash, cash equivalents and marketable securities balance compared to the prior year.
Year Ended December 31, 2003 Compared to Year Ended December 31, 2002
      Revenue. Grant revenue generated in 2002 in the amount of $547 represents federal grants received in conjunction with an undertaking to perform certain research.
      Cost of Grant Revenue. The cost of grant revenue for the year ended December 31, 2002 represents the expenses attributable to the grant revenue and consists primarily of payroll and related costs amounting to $564.
      Research and Development Expense. Research and development expenses increased $424 to $828 for the year ended December 31, 2003 from $404 for the year ended December 31, 2002. This increase was principally attributable to personnel and personnel related costs that specifically supported the grant program in 2002, and were classified as cost of grant revenue in 2002 and $93 related to an increase in other consulting and outside research fees supporting the development of our MelaFind® product. For the year ended December 31, 2003 research and development costs were approximately 45% of total operating expenses. Clinical and regulatory expense, a component of research and development expense totaled approximately $50 for the year ended December 31, 2003.
      General and Administrative Expense. General and administrative expenses increased by $523 to $1034 for the year ended December 31, 2003 from $511 for the year ended December 31, 2002. The increase was principally attributable to personnel and personnel related costs of $488 and an increase in consulting fees of $35. For the year ended December 31, 2003 general and administrative expenses were approximately 55% of total operating expenses.
      Interest (Income)/ Expense. Interest (income)/ expense for the year ended December 31, 2003 was $76 compared to $8 for the corresponding period in 2002. The increase was due to a charge of $45 associated with the value of the beneficial conversion feature for a promissory note during 2003.
Liquidity and Capital Resources (in thousands)
      From inception, we have financed our operations primarily through the use of working capital from private placements of equity securities and by applying for and obtaining a series of National Institute of Health Small Business Innovative Research grants and similar grants. To date, we have not borrowed (other than by issuing convertible notes, all of which have been converted into equity) or financed our operations through significant equipment leases, financing loans or other debt instruments. As of June 30, 2005, we had $3,794 in cash, cash equivalents and marketable securities as compared to $6,703 at December 31, 2004. Our cash, cash equivalents and marketable securities are liquid investments with a maturity within one year and consist of investments in money market funds with a commercial bank and short-term US Treasury obligations and federal agency notes.
      Cash Flows from Operating Activities. Net cash used in operations was $2,890 for the six months ended June 30, 2005. For the years ended December 31, 2002, 2003 and 2004 the net cash used in operations was $684, $1,699, and $3,065 respectively. For all periods, cash used in operations was attributable primarily to net losses after adjustment for non-cash charges related to depreciation and other changes in operating assets and liabilities.
      Cash from Investing Activities. Net cash provided by our investing activities was $2,923 for the six months ended June 30, 2005 principally relating to the redemption of investments. For the years ended December 31, 2002, 2003 and 2004 the net cash provided by (used in) investing activities was $518, $(8)

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and $(6,677) respectively. The increase in cash used in investing activities in the years ended December 31, 2003 and 2004 was principally related to the net purchase of investments and equipment from the proceeds of our private placement financings. Cash used in investing activities for the year ended December 31, 2002 reflected the redemption of investments.
      Cash Flows from Financing Activities. Net cash provided by financing activities was $35 for the six months ended June 30, 2005. For the years ended December 31, 2002, 2003 and 2004 the net cash flows provided by financing activities was zero, $1,816 and $9,733 respectively. For these periods, financing cash flows reflected the proceeds from the issuance of common stock, and preferred stock.
Operating Capital and Capital Expenditure Requirements
      To date, we have not commercialized our principal product, MelaFind®. We anticipate that we will continue to incur net losses for the foreseeable future as we continue to develop the MelaFind® system, expand our clinical development team and corporate infrastructure, and prepare for the potential commercial launch of MelaFind®. We do not expect to generate significant product revenue until we successfully obtain PMA approval for and begin selling MelaFind®. We believe that the net proceeds from this offering, together with our current cash, cash equivalents and marketable securities and interest we earn on these balances, will be sufficient to meet our anticipated cash needs for working capital and capital expenditures through mid 2008. If existing cash and cash generated from this offering are insufficient to satisfy our liquidity requirements, or if we develop additional products, we may seek to sell additional equity or debt securities or obtain a credit facility. If additional funds are raised through the issuance of debt securities, these securities could have rights senior to those associated with our common stock, and could contain covenants that would restrict our operations. Any additional financing may not be available in amounts or on terms acceptable to us, or at all. If we are unable to obtain this additional financing, we may be required to reduce the scope of, delay or eliminate some or all of planned product research development and commercialization activities, which could harm our business.
      Because of the numerous risks and uncertainties associated with the development of medical devices such as MelaFind®, we are unable to estimate the exact amounts of capital outlays and operating expenditures associated with our current and anticipated clinical trials. Our future funding requirements will depend on many factors, including, but not limited to:
  •  the schedule, costs, and results of our clinical trials;
 
  •  the success of our research and development efforts;
 
  •  the costs and timing of regulatory approval;
 
  •  reimbursement amounts for the use of MelaFind® that we are able to obtain from Medicare and third party payors, or the amount of direct payments we are able to obtain from patients and/or physicians utilizing MelaFind®;
 
  •  the cost of commercialization activities, including product marketing and building a domestic direct sales force;
 
  •  the emergence of competing or complementary technological developments;
 
  •  the costs of filing, prosecuting, defending and enforcing any patent claims and other rights, including litigation costs and the results of such litigation;
 
  •  the costs involved in defending any patent infringement actions brought against us by third parties; and
 
  •  our ability to establish and maintain any collaborative, licensing or other arrangements, and the terms and timing of any such arrangements.

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Contractual Obligations
      The following table summarizes our outstanding contractual obligations as of December 31, 2004 and the effect those obligations are expected to have on our liquidity and cash flows in future periods:
Payments Due by Period
(dollars in thousands)
                                           
        Less than           More than
Contractual Obligations   Total   1 Year   1-3 Years   4-5 Years   5 Years
                     
Operating Leases
  $ 1,114     $ 205     $ 634     $ 275        
                               
 
Total
  $ 1,114     $ 205     $ 634     $ 275        
                               
      Our long-term obligations are two non-cancelable operating leases for space expiring June 2009 and November 2010. The lease on 3,700 square feet of office, laboratory and assembly space expires in June 2009 and the lease on 2,800 square feet of office space expires November 2010.
Related Party Transactions
      For a description of our related party transactions, see the “Related Party Transactions” section of this prospectus and the related notes to our financial statements appearing at the end of this prospectus.
Off-Balance Sheet Arrangements
      We do not currently have, nor have we ever had, any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts. As such, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.
Quantitative and Qualitative Disclosures about Market Risk
      Our exposure to market risk is confined to our cash equivalents and short-term investments. We invest in high-quality financial instruments; primarily money market funds, federal agency notes, and US Treasury obligations, with the effective duration of the portfolio within one year which we believe are subject to limited credit risk. We currently do not hedge interest rate exposure. Due to the short-term nature of our investments, we do not believe that we have any material exposure to interest rate risk arising from our investments.
Recent Accounting Pronouncements
      In May 2003, FASB issued Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (SFAS No. 150). This statement establishes how a company classifies and measures certain financial instruments with characteristics of both liabilities and equity, including redeemable convertible preferred stock. This statement is effective for financial instruments entered into or modified after May 31, 2003, and is otherwise effective at the beginning of the interim period commencing July 1, 2003, except for mandatorily redeemable financial instruments of nonpublic companies. FASB has indefinitely deferred implementation of some provisions of SFAS No. 150. The adoption of SFAS No. 150 did not have a material effect on our financial position or results of operations.

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OUR BUSINESS
Overview
      We are a medical device company focused on the design and development of a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma. Our flagship product, MelaFind® features a hand-held imaging device that emits multiple wavelengths of light to capture images of suspicious pigmented skin lesions and extract data. The data are then analyzed against our proprietary database of melanomas and benign lesions using our sophisticated algorithms in order to provide information to the physician and produce a recommendation of whether the lesion should be biopsied.
      The components of the MelaFind® system include:
  •  a hand-held imaging device, which employs high precision optics and multi-spectral illumination (multiple colors of light including near infra-red);
 
  •  our proprietary database of pigmented skin lesions, which we believe to be the largest in the US;
 
  •  our lesion classifiers, which are sophisticated mathematical algorithms that extract lesion feature information and classify lesions; and
 
  •  a central server in our offices that is intended to perform quality control functions and provide reports to the physician and in commercial use, will be connected to physicians’ offices via the internet.
      We have entered into a binding Protocol Agreement with the FDA which is an agreement for the conduct of the pivotal trial in order to establish the safety and effectiveness of MelaFind®. We believe the presence of the Protocol Agreement significantly enhances our ability to expedite the FDA approval process. We stopped a study that was initiated in late 2004 under the Protocol Agreement due to technical difficulties with some of the MelaFind® clinical trial instruments. The FDA has provided confirmation that our plan to correct the technical issues and start a new pivotal trial to satisfy the Protocol Agreement is acceptable. Management estimates that the pivotal trial will commence in early 2006 at over 20 US clinical study sites, and anticipates PMA approval to commercialize MelaFind® in 2007.
      To date, we have not generated any revenues from MelaFind®. All of our historical revenues have come from activities and products that have since been discontinued, including our DIFOTI® product, a non-invasive imaging device for the detection of dental cavities. We decided to discontinue all operations associated with our DIFOTI® product, effective as of April 5, 2005, in order to focus our resources on the development and commercialization of MelaFind®.
      Cancers of the skin have a higher incidence than all other cancers combined, and the rates are rising dramatically. In 2005, over 120,000 new cases of melanoma are projected. Melanoma is responsible for approximately 80% of skin cancer fatalities and is the deadliest of all skin cancers as there is currently no cure for advanced stage melanoma. However, early detection of skin cancers like melanoma can lead to virtually a 100% cure rate. Advanced stage melanoma is costly to treat and is responsible for approximately 90% of the total spending on melanoma treatment in the US, costing up to $170,000 per patient. If diagnosed early, however, melanoma is almost always cured by simple resection at a cost of approximately $1,800 per patient.
      Because early detection is critical to survival, the American Cancer Society recommends that individuals age 40 years and older have complete skin examinations on an annual basis. According to the 2000 US Census data, over 100 million Americans in the US are over age 40. Furthermore, there are more than 20 million individuals in the US who have dysplastic nevi, a type of pigmented skin lesion that when present is associated with an increased risk of melanoma. These individuals warrant more frequent observation.
      Melanomas are mainly diagnosed by dermatologists and/or primary care physicians using visual clinical evaluation. Physicians assess pigmented skin lesions using the “ABCDE” criteria, Asymmetry, Border irregularity, Color variation, Diameter greater than 6 mm, and Evolving — change in ABCD over time. This assessment is subjective and results in missed melanomas, as well as a ratio of benign lesions

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biopsied to melanomas confirmed that is highly variable and as high as 40 to 1 for dermatologists and as high as 50 to 1 for primary care physicians.
      To date, MelaFind® has been studied on over 5,000 skin lesions from over 3,500 patients at over 20 clinics. Our clinical studies have demonstrated that MelaFind® missed fewer melanomas and produced fewer false positives than experienced by study dermatologists, who are skin cancer specialists. The performance of a diagnostic is measured in terms of “sensitivity” (the ability to detect disease when disease is present) and “specificity” (the ability to exclude disease when disease is not present). In the largest blinded trial that we have performed to date on 352 suspicious pigmented skin lesions, using our most advanced system, MelaFind® did not miss a melanoma (measured sensitivity of 100%) and achieved 48.4% specificity compared to the study dermatologists’ sensitivity of 96.4% and specificity of 28.4%.
      We believe that with the assistance provided by MelaFind®, physicians could diagnose more melanomas at the earliest, curable stage, which would reduce both treatment costs and the number of unnecessary biopsies, and improve quality of life.
      Our objective is for MelaFind® to become an integral part of the standard of care in melanoma detection.
The Market Opportunity
      Cancer of the skin (nonmelanoma and melanoma skin cancers combined) is the most common of all cancers, projected to be over 1.3 million cases in 2005 and estimated to account for more than 50% of all cancers. In 2005, over 120,000 new cases of melanoma are projected. There are three significant forms of skin cancer: basal cell, accounting for approximately 75% of skin cancer; squamous cell, totaling approximately 20%; and melanoma, which accounts for an estimated 4% of skin cancer cases, but is responsible for approximately 80% of all deaths from skin cancer. The American Cancer Society projects 10,600 deaths from skin cancer in 2005 — 7,800 from melanoma and 2,800 from other skin cancers. Since 1973, the mortality rate for melanoma has increased by 50%. Since approximately 62% of melanomas and 45% of melanoma deaths occur prior to age 65, melanoma places significant burdens on the healthcare system well beyond Medicare.
      Melanoma, if left untreated, can be fatal. If diagnosed and removed early in its evolution, when confined to the outermost skin layer and deemed to be “in situ,” it is virtually 100% curable. Invasive melanomas that are thin and extend into the uppermost regions of the second skin layer still have excellent cure rates (greater than 90%). However, once the cancer advances into the deeper layers of skin, the risk of metastasis (spreading to other parts of the body) increases. Metastases can occur when the tumor enters into lymphatic channels and newly formed blood vessels, potentially resulting in significant morbidity (illness) and mortality (death). Once the cancer has advanced and metastasized to other parts of the body, it is difficult to treat. At this advanced stage, the five year survival rate is reported to be only 10%. Moreover, survival prospects for those with advanced melanoma have not improved over the past three decades.
      Melanoma is currently the subject of significant attention in the medical community. In part, this attention is due to the fact that it is the fastest growing cancer. It is also the most common cancer in young adults ages 20-30, and currently there are more new cases of melanoma than HIV/ AIDS. In women ages 25-30, melanoma is the primary cause of cancer death. In women ages 30-35, melanoma is the second leading cause of death after breast cancer. Recent published papers identify a strong correlation between breast cancer and melanoma.
      Because early detection is critical to survival, the American Cancer Society recommends that individuals 40 years and older have complete skin examinations on an annual basis. The 2000 US Census indicates that there are over 100 million Americans over the age of 40 in the US. Furthermore, there are more than 20 million individuals in the US who have dysplastic nevi, a type of pigmented skin lesion that

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when present is associated with an increased risk of melanoma. Such individuals warrant more frequent observation.
Our Strategy
      Our objective is for MelaFind® to become an integral part of the standard of care in melanoma detection. To achieve this objective, we are pursuing the following strategy:
  •  Pursue the timely FDA approval of MelaFind®: We have entered into a binding Protocol Agreement with the FDA for the conduct of the pivotal trial of MelaFind®. Management estimates that the study will commence in early 2006 at over 20 US clinical study sites, and anticipates PMA approval to commercialize MelaFind® in 2007.
 
  •  Establish MelaFind® as the leading technology for assisting in the detection of melanoma: We have invested considerable capital and expertise into developing our core technology platform, which is protected by six US patents. We will continue to refine and optimize this technology to ensure that MelaFind® is the leading system for assisting in the detection of melanoma.
 
  •  Obtain third party payor reimbursement to support our recurring revenue pricing model: We intend to offer MelaFind® on a per patient basis, creating a recurring revenue stream. To do so, we will seek to obtain third party reimbursement as well as private pay alternatives. We are working with experts to create an evidence-based medicine evaluation model consistent with those used to support positive coverage decisions by CMS and private payors for similar products. The value drivers in the model include the cost savings associated with early detection (approximately $168,000 per patient) and fewer biopsies. We believe that the use of MelaFind® could result in substantial savings to the US healthcare system.
 
  •  Commercialize MelaFind® using multiple sales and marketing strategies: Our internal sales and marketing effort will focus initially on “high volume/key opinion leader” dermatologists with specialties in the diagnosis and treatment of melanoma. To enter the larger US markets of general dermatologists, plastic surgeons, and primary care physicians, and for international markets, we intend to establish partnerships with pharmaceutical and/or diagnostic device companies with an established presence in these markets. While we believe obtaining a positive coverage decision from CMS may take an additional 18 to 36 months following PMA approval, and obtaining a positive coverage decision from private payors, managed care organizations and state Medicare administrative contractors may take at least 6 to 12 months following PMA approval, we intend to commence sales of MelaFind® immediately upon receiving PMA approval for physicians to offer MelaFind® to their patients on a self-pay basis.
Limitations of Current Melanoma Diagnosis
      The current primary method for detecting melanoma is based on physicians’ ability to recognize patterns using the naked eye; this is known as clinical examination. Physicians assess pigmented skin lesions using the “ABCDE” criteria, Asymmetry, Border irregularity, Color variation, Diameter greater than 6 mm, and Evolving — change in ABCD over time. This subjective interpretation relies on physician experience and skill. The ratio of benign lesions biopsied to melanomas confirmed can be variable, ranging as high as 40 to 1 for dermatologists and as high as 50 to 1 for primary care physicians. In contrast, MelaFind® delivers an objective assessment based on numerical scores assigned to the suspicious skin lesion under evaluation. Further, clinical examination is limited to the surface appearance of the suspicious pigmented skin lesion, whereas MelaFind® utilizes information derived from up to 2.5 mm deep into the skin.
      Dermatologists who specialize in the management of pigmented skin lesions may also use dermoscopy, a method of viewing lesions under magnification. Although dermoscopy provides more information than unaided visual examination, mastery of the technique necessitates many years of training

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and experience. Proper use of dermoscopy can reduce the number of unnecessary biopsies of benign lesions, but even dermoscopy experts biopsy 3-10 benign lesions for every melanoma detected.
      Most dermatologists generally use only visual clinical evaluation for melanoma detection. Consequently, they biopsy up to 40 benign lesions for every melanoma detected. While many primary care physicians immediately refer patients with suspicious pigmented skin lesions to a specialist, an increasing number perform biopsies on skin lesions themselves. Their lack of specialist training in identifying suspect lesions makes their diagnostic accuracy much lower in terms of both sensitivity and specificity. This results in 40% misdiagnosed melanomas and a ratio of benign lesions biopsied to melanomas confirmed of up to 50 to 1.
MelaFind® Product Description
      MelaFind® is a non-invasive system for assisting in the early detection of melanoma. The MelaFind® system is comprised of a point-of-care, hand-held imaging device that, in commercial use, is intended to be connected via the internet to a central server in our offices. MelaFind® employs multiple wavelengths of light to obtain data from images of suspicious lesions; the data are analyzed against our proprietary database of melanomas and benign lesions using our sophisticated algorithms. When marketed, a report will be transmitted to the physician’s office containing MelaFind®’s recommendation of whether the lesion should be biopsied. The key components of the MelaFind® system are listed below:
      A hand-held imaging device, which is comprised of several components:
  •  an illuminator that shines 10 different specific wavelengths of light, including near infra-red bands;
 
  •  a lens system composed of nine elements that creates images of the light reflected from the lesions;
 
  •  a photon (light) sensor; and
 
  •  an image processor employing proprietary algorithms to extract many discrete characteristics or features from the images.
  Our proprietary database of pigmented skin lesions, which includes in vivo MelaFind® images and corresponding histological results of over 5,000 biopsied lesions from over 3,500 patients, which we believe to be the largest such database in the US and a substantial barrier to competition.
 
  Our lesion classifiers, which are sophisticated mathematical algorithms that analyze the MelaFind® images and extract lesion feature information from the images; the features are used to classify the lesions as either suspicious for melanoma or not suspicious for melanoma.
 
  A central server located in our offices, which is intended to perform quality control functions and provide diagnostic reports to the physician.
      The “brain” of the MelaFind® system, the Lesion Classifier, distinguishes melanoma from non-melanoma using the lesion features extracted and measured by the hand-held imaging device. The Lesion Classifiers are developed from our proprietary database of pigmented skin lesions and sophisticated mathematical algorithms. The mathematical formulas and algorithms used by the Lesion Classifiers are devised and optimized through the process of “classifier training” using lesions from our proprietary database. Lesion Classifier development and training is an iterative process involving: (1) selection of the lesion features that provide for optimal lesion discrimination; (2) optimization of the mathematical formulas to differentiate benign lesions from melanoma; and (3) expansion of the size and diversity of our proprietary lesion database. The performance of the Lesion Classifiers is directly related to the size of the database used in classifier training, as well as the degree to which the training database is representative of the lesions that will be evaluated by MelaFind® in commercial use.
      As with many diagnostic systems, the diagnostic performance of MelaFind® is characterized using two measures: (1) sensitivity  — the ability to detect disease when it is present; and (2) specificity  — the ability to exclude disease when it is not present. Since sensitivity and specificity are typically trade-offs, meaning that as one parameter increases the other decreases, the MelaFind® Lesion Classifier is developed

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and trained with the intention that MelaFind® will detect all melanomas in the training data set with the highest possible specificity.
      Reliable functioning of the MelaFind® system is critical to its utility and success in the marketplace. Automated self-calibration tests are performed by the hand-held device to ensure proper functionality. When marketed, the central server will also perform tests on the hand-held device to determine whether its functioning is within appropriate limits, that is, that the quantitative data on lesion and calibration image features provided by MelaFind® are within a pre-determined expected range of values. The server will not permit MelaFind® to provide diagnostic information unless the hand-held device is functioning properly.
MelaFind® Regulatory Status
      In late 2004, we entered into a binding Protocol Agreement with the FDA for our pivotal clinical study. A pivotal trial is a clinical study that is used by the FDA as the basis for determining the effectiveness of a device in a PMA application. The Protocol Agreement specified the inclusion criteria (description of patients and lesions eligible for the trial), sample size, endpoints, and performance criteria necessary to establish the safety and effectiveness of MelaFind®. The Protocol Agreement requires that the study include at least 1,200 pigmented skin lesions, and at least 93 eligible melanomas for analysis.
      The primary endpoints of the study include: (1) greater than 95% (lower confidence bound (a statistically derived lower limit of a measured or observed value based on the number of observations used to derive the measured or observed value)) sensitivity for detection of melanoma (99% observed sensitivity); and (2) statistically significant greater specificity in ruling out melanoma when compared to study dermatologists. The lower confidence bound of 95% sensitivity is a statistically-derived lower limit of sensitivity based on an observed sensitivity of 99%. This means that in order to satisfy the sensitivity requirement, MelaFind® must correctly identify at least 92 of the 93 melanomas, that is, miss either none or one melanoma in the pivotal trial. In order to satisfy the specificity requirement, MelaFind® must demonstrate a higher specificity than study dermatologists at a level where the probability of obtaining such a result by chance is less than 5%. For illustrative purposes, assuming a specificity of 25% for study dermatologists, the specificity of MelaFind® would need to be at least 32% in order for the difference to be statistically significant at the 95% confidence level.
      We initiated a clinical trial under the terms of the Protocol Agreement at the end of 2004. However, technical operational issues with the systems were experienced, requiring further refinement. We are continuing this study as a supportive pilot study. A pilot study is one that provides information regarding the operation of a device in the clinical setting as well as the feasibility of various clinical trial evaluations. Pilot studies are often used to help refine certain elements of a planned pivotal trial and serve to train study personnel in advance of a pivotal trial.
      We are currently refining the hardware systems and expect to have new systems available in order to start the pivotal trial in early 2006. The pivotal trial for PMA approval of MelaFind® will be conducted under the terms of the Protocol Agreement. We have reviewed our strategy with the FDA and have obtained confirmation from the FDA that our plan to correct the technical issues by refining the hardware systems and to start a new pivotal trial to satisfy the Protocol Agreement is acceptable.
      For commercialization outside the US, approvals from appropriate regulatory bodies within other countries will be required. Once PMA approval is obtained, we may proceed with applications to commercialize in various countries pending further assessment of market opportunities and the possible identification of strategic partners.
Clinical Studies of MelaFind®
     Goals and Objectives
      MelaFind® has been studied on over 5,000 skin lesions from over 3,500 patients during the past five years at over 20 clinical sites in the US, as well as two sites in Europe and one in Australia. We aim to

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develop a system with a sensitivity of at least 95% in detecting melanoma. Our goals are to complete pre-commercialization design and testing of the hand-held imaging device and its associated software, as well as to establish a database of approximately 300 melanomas, including in vivo MelaFind® images and biopsy results, for MelaFind® Lesion Classifier algorithm development and training. Statistically, in order to have a high level of confidence of success, we set the lower confidence bound at 99%, which requires approximately 300 melanomas in the classifier training database. To date, the MelaFind® lesion database includes 225 melanomas.
      We are developing in parallel several MelaFind® Lesion Classifiers, which differ in the algorithms, as well as in the specific lesion features and relative weights used in the mathematical formulas. Prior to conducting the analysis of the data from the pivotal trial under the Protocol Agreement, the optimal Lesion Classifier will be selected. The primary means by which the performance of the MelaFind® Lesion Classifiers is evaluated is through measures of sensitivity (the ability to detect disease when present) and specificity (the ability to exclude disease when not present).
      The reference standard used for comparison of the results of MelaFind® and study dermatologists is histological analysis of the biopsied lesions by a group of expert pathologists. MelaFind® images of pigmented skin lesions (melanomas and non-melanomas) and the histological results of the corresponding biopsied lesions comprise our training database of lesions. When the Lesion Classifiers are tested on the database used in training, this is called a “training study.” When the Lesion Classifiers are tested on a set of lesions not used in training, this is called a “blinded test,” which is a simulation of anticipated real-life prospective classifier performance.
      Our ultimate goal for MelaFind® is to demonstrate sensitivity of at least 95%, and superior specificity as compared to study dermatologists in the pivotal blinded test for PMA approval.
     MelaFind® Development History — Hardware and Software
      In developing the MelaFind® system we have tested both a first and second generation hand-held imaging device, and are in the process of developing a pre-commercialization version for use in our pivotal clinical trial. Our research, development and clinical testing efforts have been designed to improve our MelaFind® technology platform, including the imaging device and lesion classifiers, and to enhance our lesion database.
      We began using first generation hand-held imaging devices in clinical studies in 2001. In 2002, we expanded the clinical research program to additional study sites equipped with second generation hand-held imaging devices. The aim of the study, which is ongoing, is to build the MelaFind® proprietary lesion database for use in Lesion Classifier training. The study calls for the MelaFind® hand-held imaging device to acquire images of pigmented skin lesions scheduled for biopsy. After biopsy, the histological slides are collected and sent for central histological review by a panel of experts.
      The results of initial training studies and blinded tests were not to the expected level of performance. We determined the cause to be a flaw in the second generation hand-held imaging devices, which were subsequently shown to exhibit highly variable levels of stray light, an optical artifact. Therefore, we ceased producing this generation of hand-held imaging devices and purged the training database of lesion images acquired with them. We also incorporated a manufacturing specification for stray light which, prior to this time, was not included. Subsequent training studies and blinded tests performed using only first generation hand-held imaging devices confirmed our earlier favorable results: MelaFind® missed none or very few melanomas, and was shown to have higher specificity than study dermatologists, as shown in the tables below. See “Our Business — Clinical Studies of MelaFind® — Results of Training Studies and Blinded Tests.”
      We initiated a clinical study under the terms of the Protocol Agreement with the FDA in late 2004 using first generation hand-held imaging devices. However, several technical operating issues with these older systems were experienced, requiring further refinement. Third generation hand-held imaging devices were produced in 2004 and early 2005. These serve as the basis of the design that is currently being used

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to generate final, pre-commercialization hand-held imaging devices, which will be utilized in the pivotal study for PMA approval under the terms of the Protocol Agreement.
      Along with hardware development efforts, we have also developed, tested, and continue to refine the software components of the system, including lesion filters, calibration algorithms, lesion classification algorithms, and hardware normalization software. We plan to finalize these key elements of the software prior to the analysis of the data obtained from the pivotal trial for PMA approval.
     Results of Training Studies and Blinded Tests
      The first iteration of MelaFind® Lesion Classifiers, Lesion Classifiers A-1 and B, employed a single-step process, that is, an algorithm that differentiates melanoma from all other pigmented skin lesions. These MelaFind® classifiers were trained on a total of 1,129 lesions  — 109 melanomas, 70 high grade dysplastic nevi, and 950 other pigmented skin lesions. For the blinded test, a different group of 477 pigmented skin lesions, including 26 melanomas, 11 high grade dysplastic nevi, and 440 other lesions were included. None of these lesions were used in classifier training. The results of the training study and blinded tests for MelaFind® Lesion Classifiers A-1 and B, as well as study dermatologists, are summarized below.
August 2003 — Training Study and Blinded Test Results
                                 
    Training Study   Blinded Test
         
    Sensitivity   Specificity   Sensitivity   Specificity
                 
MelaFind® Lesion Classifier A-1
    100 %     45.6 %     80.8 %     44.3 %
MelaFind® Lesion Classifier B
    96.3 %     21.9 %     80.8 %     25.5 %
Study Dermatologists
    N/A       N/A       96.2 %     17.3 %
      The performance of the MelaFind® Lesion Classifiers on the blinded data set was significantly below results from the training study. The first attempt to improve the performance was by developing a new MelaFind® Lesion Classifier A, employing a three-step process (A-3), which was accomplished in November 2003. A three-step process employs algorithms that differentiate melanoma from three other classes of pigmented skin lesions. The new classifier was re-trained on the original data set of lesions (109 melanomas, 70 high grade dysplastic nevi, and 950 other pigmented skin lesions), tested on the training set and then tested on the same blinded data set used in August 2003 (26 melanomas, 11 high grade dysplastic nevi, and 440 other lesions). The following table summarizes the results of the tests on the training and blinded data sets. Note that MelaFind® Lesion Classifier B, which accommodates a single-step process only, was not evaluated in these exercises.
November 2003 — Training Study and Blinded Test Results
                                 
    Training Study   Blinded Test
         
    Sensitivity   Specificity   Sensitivity   Specificity
                 
MelaFind® Lesion Classifier A-3
    100 %     28.5 %     100 %     25.7 %
Study Dermatologists
    N/A       N/A       96.2 %     17.3 %
      Review of the data indicated that the three-step MelaFind® Lesion Classifier A-3, which was trained with lesions acquired from first and second generation MelaFind® hand-held imaging devices, was much less specific on the training database (28.5%) than the single-step classifier MelaFind® Lesion Classifier A-1, which was trained on lesions acquired using only first generation hand-held imaging devices (45.6%). A complete analysis of all MelaFind® devices from the clinical sites indicated a systematic difference between the first generation and second generation MelaFind® hand-held imaging devices. The second generation hand-held imaging devices exhibited a significantly greater amount of stray light than the first generation hand-held imaging devices. Stray light induces variable imaging artifacts that cannot be predicted or accounted for in the software algorithms, and introduces higher probability for error. Therefore, in February 2004, all lesions acquired using second generation hand-held imaging devices were

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removed from the training and testing databases. The three-step MelaFind® Lesion Classifier A-3 was then trained on a set of lesions acquired solely from first generation hand-held imaging devices including 113 melanomas, 69 high grade dysplastic nevi, and 987 other pigmented skin lesions. A blinded test was conducted on 262 lesions (21 melanoma, 8 high grade dysplastic nevi, and 233 other lesions) not used in classifier training and acquired using first generation hand-held imaging devices only. The following table summarizes the results.
February 2004 — Results of Training Study and Blinded Test after Removing Lesions
Obtained from Second Generation Hand-Held Imaging Devices
                                 
    Training Study   Blinded Test
         
    Sensitivity   Specificity   Sensitivity   Specificity
                 
MelaFind® Lesion Classifier A-3
    100 %     43.8 %     100 %     44.2 %
Study Dermatologists
    N/A       N/A       95.0 %     28.3 %
      These results demonstrated the importance of minimizing stray light and establishing a product specification for stray light. This specification was instituted in our assembly process following this analysis. As part of the continued development, a four-step MelaFind® Lesion Classifier A-4 was introduced in March 2004. A four-step process employs algorithms that differentiate melanoma from four other classes of pigmented skin lesions. This classifier performed better compared with the three-step classifier, as summarized in the following table.
March 2004 — MelaFind® Lesion Classifiers: Three-step vs. Four-step
Training Study and Blinded Test Results
                                 
    Training Study   Blinded Test
         
    Sensitivity   Specificity   Sensitivity   Specificity
                 
MelaFind® Lesion Classifier A-3
    100 %     43.8 %     100 %     44.2 %
MelaFind® Lesion Classifier A-4
    100 %     48.9 %     100 %     48.1 %
Study Dermatologists
    N/A       N/A       95.0 %     28.3 %
      Due to the enhanced specificity of the four-step classifier A-4 compared to the three-step classifier A-3, as seen in the preceding table, the four-step classifier was selected for further development and testing. In May 2004, the largest blinded test was performed on a separate set of 352 lesions (including 28 melanomas, 14 high grade dysplastic nevi, and 310 other pigmented skin lesions) that were not used in classifier training. The results of sensitivity and specificity of MelaFind® Lesion Classifiers A-4 and B and study dermatologists are summarized in the following table.
May 2004 — Training Study and Blinded Test Results
                                 
    Training Study   Blinded Test
         
    Sensitivity   Specificity   Sensitivity   Specificity
                 
MelaFind® Lesion Classifier A-4
    100 %     53.2 %     100 %     48.4 %
MelaFind® Lesion Classifier B
    100 %     38.0 %     96.4 %     32.9 %
Study Dermatologists
    N/A       N/A       96.4 %     28.4 %
      In January 2005, with no additional classifier training and in an effort to rigorously test the limits of the MelaFind® Lesion Classifiers, another blinded test was performed on 228 new lesions (28 melanomas, 4 high grade dysplastic nevi, and 196 other pigmented skin lesions). The lesions in this blinded test were acquired from the first generation MelaFind® hand-held imaging devices that had been at the clinical sites for a longer period of time than in any blinded test to date. Lesion Classifier training was not performed using MelaFind® hand-held imaging devices that had been at the clinical sites for longer periods of time. A new four-step MelaFind® Lesion Classifier C-4 with a revised step was also evaluated in the blinded test. The results are summarized in the following table.

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January 2005 — Second Blinded Test Results using March 2004 Classifiers
                 
    Sensitivity   Specificity
         
MelaFind® Lesion Classifier A-4
    82.1 %     37.2 %
MelaFind® Lesion Classifier B
    96.4 %     21.0 %
MelaFind® Lesion Classifier C-4
    92.9 %     35.7 %
Study Dermatologists
    92.9 %     23.0 %
      In evaluating the MelaFind® hand-held imaging devices used in the January 2005 blinded test, we found that several MelaFind® devices were not performing within specifications. Certain lesions had some feature measurements significantly outside of the range of the previous data. This led to the identification of specific problems with the hardware, which enabled a new and more robust design of MelaFind® hand-held imaging devices. Had these devices performed within specifications, we believe that the sensitivity of MelaFind® Lesion Classifiers A-4 and C-4 would have been 96.4%, that is, they would have missed one melanoma, compared to study dermatologists who missed two melanomas.
      We are utilizing the findings of the blinded tests to refine the design of hardware to further develop the lesion classification algorithms, to expand the training database, and to develop improved calibration methods to ensure appropriate functioning of each hand-held imaging device. As demonstrated in the January 2005 blinded test, melanomas can be missed when MelaFind® systems that do not meet specifications are used to acquire images, and when melanoma lesion types (for instance, nodular melanomas, a melanoma type that is often missed by dermatologists in early stages) are not adequately represented in the training database. In order to address these situations, we have: (1) incorporated a weekly field calibration test to evaluate system performance in order to identify and disable MelaFind® systems that are not functioning within specifications; (2) intensified our effort to obtain images of nodular melanomas for inclusion in the targeted 300 melanoma database for the final Lesion Classifier; and (3) refined our algorithms to result in either a positive reading of melanoma when MelaFind® images reveal characteristics well outside the ranges of lesions in the final training database, or to report that MelaFind® cannot provide a diagnosis in this circumstance. As mentioned above, had these devices performed within specifications, we believe that the sensitivity of MelaFind® Lesion Classifiers A-4 and C-4 would have been 96.4%, that is, they would have missed one melanoma, compared to study dermatologists who missed two melanomas.
      Conclusion
      In the largest clinical study performed to date on 352 pigmented skin lesions, MelaFind® identified all melanomas (100% measured sensitivity) and had a specificity superior to study dermatologists on a statistically significant basis (48.4% versus 28.4%; the probability of obtaining this result by chance was less than 0.0001). Taken together, we believe the clinical studies performed to date demonstrate that MelaFind® hardware systems that are functioning within specifications and that use the most advanced MelaFind® software and classifiers, provide results consistent with the requirements of the Protocol Agreement, that is, specificity that is superior to study dermatologists on a statistically significant basis, and observed sensitivity of at least 99%.
      The studies performed to date have been executed with prototype hardware systems as well as MelaFind® classifiers and software that were under development. We believe that results similar or superior to the results obtained in the largest study will be observed in the pivotal clinical study for PMA approval, which will employ pre-commercialization hardware systems with the most advanced software and MelaFind® classifiers. We believe that the pivotal study will demonstrate specificity superior to study dermatologists on a statistically significant basis and satisfy the requirements of the Protocol Agreement.
Sales and Marketing
      We plan to offer MelaFind® as a point-of-care online service. This approach is intended to provide us with the advantage of recurring revenues corresponding to the number of patients examined and to provide the physician with access to our technology without having to make a significant capital investment.

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      Our sales and marketing strategy is to initially establish focused sales, marketing, and distribution organization in North America. We plan to focus our commercialization efforts initially on “high volume/key opinion leader” dermatologists who are strongly focused on the diagnosis and treatment of melanoma. For the expansion to the larger US markets of general dermatologists, plastic surgeons, and primary care physicians, and for international markets, we intend to establish development and commercialization partnerships with pharmaceutical and/or diagnostic device companies with an established competency in the market to accelerate the product introduction and to maximize the breadth of the commercial opportunity. At this time, we have not yet established any commercialization partnerships.
      We believe that the ultimate market for MelaFind® is in the primary care setting. When used by primary care physicians, MelaFind® could have a significant public health benefit and a favorable impact on healthcare costs. Primary care physicians are at the front line of early detection, but their lack of specialist training in identifying suspect lesions makes the achievement of a high level of diagnostic accuracy challenging. We believe that MelaFind® can significantly assist primary care physicians in improving their diagnostic acumen.
     The MelaFind® Value Proposition for the Healthcare System
      We are currently working with experts on a quantitative analysis of the value proposition of the use of MelaFind® by both dermatologists and primary care physicians using Evidence-Based Medicine evaluation techniques. This strategy is consistent with the approach that has been used to support positive coverage decisions by CMS and private payors for other products. The value drivers include: (1) the diagnosis of melanoma at the early curable stages, as opposed to advanced stages, allowing for both a greater opportunity to cure and a reduction in treatment costs by approximately 99%; and (2) reduced number of referrals for evaluation and biopsy of benign pigmented skin lesions. We believe that the use of MelaFind® could result in substantial savings to the US healthcare system.
     Our Reimbursement Strategy
      We are aware of no Current Procedural Terminology (CPT) code that is specifically applicable to the use of MelaFind®. Therefore, we have engaged the services of expert consultants with extensive experience in the CPT and coverage decision processes to assist us in the submission of appropriate applications to obtain a CPT code(s) and positive coverage decisions from CMS and private payors.
      In advance of obtaining a CPT code, we intend to extend our efforts to secure coverage by private payors and state Medicare administrative contractors. Securing coverage first through private payors and state Medicare administrative contractors is a common strategy for facilitating national Medicare coverage. Our efforts to secure reimbursement for services using MelaFind® will focus first on private payors and state Medicare administrative contractors, particularly in sunbelt locations and in areas that have been shown to be underserved by dermatologists.
      In the US, healthcare providers that utilize medical systems such as MelaFind®, generally rely on third-party payors, including Medicare, Medicaid, private health insurance carriers, and managed care organizations, to reimburse part, but not necessarily all, of the costs and fees associated with the procedures performed using these devices. Public and professional concern about the cost of medical care and new technologies has evoked a variety of remedies. Third-party payors are increasingly challenging the pricing of medical products and procedures. Guidelines have been established that recognize the need for clinical strategies to assess the cost-effectiveness of new diagnostic tools or procedures (Evidence-Based Medicine), in the hope of reducing the variations in diagnostic and treatment protocols and reducing healthcare expenditures.
      Insurers are also attempting to curb utilization by applying a rational analysis of the costs versus benefits of new technologies.
      The Evidence-Based Medicine evaluation that we are undertaking is central to our efforts to obtain positive coverage decisions from CMS and private insurers. The importance of Evidence-Based Medicine is underscored by recent actions by CMS, including its proposed Covered with Evidence Development

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initiative designed to provide quicker access to new technologies for beneficiaries while assuring that appropriate evidence for final coverage decisions will be obtained.
      Assuming FDA approval of MelaFind® in 2007, we anticipate submitting an application for a new CPT code to the American Medical Association (AMA) CPT Editorial Panel in late 2007, anticipating possible issuance of a new CPT code and positive national or regional Medicare coverage determinations in the first or second quarter of 2009. The Evidence-Based Medicine evaluation will be included in the application. If the CPT Editorial Panel concurs that a new CPT code is needed and appropriate, and we are able to demonstrate that MelaFind® is reasonable and necessary for the Medicare population, we anticipate that the new code would be referred to the AMA’s Relative Value Scale Update Committee (RUC) to determine the appropriate level of Medicare Part B reimbursement for the procedure, relative to other physician services. This analysis would include a survey of physicians utilizing MelaFind® in the commercial setting. In setting Medicare reimbursement rates, CMS is generally guided, though not bound, by the recommendation of the RUC. Medicare coverage and payment policies significantly influence the practices and policies of private payors, managed care organizations, and state Medicaid agencies. We expect to commence efforts to obtain positive coverage decisions from private payors, managed care organizations, Medicaid agencies, and state Medicare administrative contractors following the completion of the pivotal clinical trial or PMA submission. Presentations to the various committees that evaluate new technologies will be made. These will include the Evidence-Based Medicine evaluation and value proposition. We believe it is likely that the private payors, managed care organizations, and state Medicare administrative contractors will desire to establish pilot programs of MelaFind® to determine the impact of the product in their systems following PMA approval. In the case of private payors, managed care organizations and state Medicare administrative contractors, we anticipate that obtaining a positive coverage decision for MelaFind® may take at least 6 to 12 months following PMA approval.
      One of the keys to securing reimbursement is the desire of physicians to use a new technology in order to enhance their diagnostic acumen and improve the standard of care. Likewise, we believe that once patients become aware of the availability of MelaFind®, they may demand that their physicians utilize MelaFind®. We believe that MelaFind® will represent an improvement in the standard of care for the detection of melanoma. As such, we anticipate that its adoption by physicians and reimbursement by payors will be facilitated by medical and scientific evidence published in peer-reviewed journals and presentations at scientific and medical meetings including the American Academy of Dermatology annual and regional meetings. We plan to execute a publication strategy and to provide information for continuing medical education efforts in order to communicate the potential of MelaFind® to improve patient care. We also plan to sponsor clinical trials following PMA approval in order to evaluate MelaFind® in additional settings. We anticipate that the results of these studies will also be published in peer-reviewed journals and presented at scientific and medical meetings. We anticipate that these studies will help to demonstrate the potential of MelaFind® to improve patient care.
      We recognize that a favorable reimbursement environment will have a significant impact on MelaFind®’s adoption and commercial success. Even if a procedure is eligible for reimbursement, the level of reimbursement may not be adequate. In addition, third-party payors may deny reimbursement if they determine that the device used in the treatment was not cost-effective or was used for a non-approved indication. We have anticipated this need and have employed an active strategy to obtain medical coverage, identify appropriate coding and establish adequate payment.
      Pending approval of a CPT code and the availability of third party reimbursement, we plan to offer MelaFind® to physicians, who would pay for using MelaFind®, and may or may not charge patients directly for its use. For example, in capitated systems such as certain managed care plans (where physicians cannot pass costs on to patients, but rather are paid a fixed amount per patient managed under the plan, whether or not treated) physicians may conclude that it is cost-effective to use MelaFind® in order to reduce utilization of other services such as biopsies, for example, when the MelaFind® result indicates biopsy is not recommended. In addition, we believe that roughly ten percent of all dermatological practices are focused on cosmetic dermatology. Most procedures performed in cosmetic dermatological practices and Medi-Spas are provided on a patient self-pay basis. Medi-Spas are health and beauty clubs and spas in which medical care and supervision by licensed medical practitioners such as doctors, nurses and physicians assistants is provided; they specialize in

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aesthetic medicine. We believe that healthcare consumers that seek these services are likely to pay for MelaFind®, as well.
Competition
      We are not aware of any direct competitors to MelaFind®. A number of systems for visualization and assessment of pigmented skin lesions are in use or in development. These include clinical (naked eye) examination, whole body mole mapping systems, dermoscopes (also known as “dermatoscopes”), digital dermoscopes, spectrophotometric intercutaneous analysis (analysis of skin structures through measurement of how they absorb light of different wavelengths), confocal microscopy, and spectrophotometric (color) analysis. These systems rely on physician experience and expertise in recognizing patterns that are associated with melanoma and non-melanoma in order to render an interpretation and diagnosis.
      The current primary method for detecting melanoma relies on physicians to interpret whether a pigmented skin lesion is suspicious for melanoma (thereby requiring biopsy) based on their ability to recognize patterns using clinical examination. Physicians use the “ABCDE” criteria, Asymmetry, Border irregularity, Color variation, Diameter greater than 6 mm, and Evolving in ABCD, in their assessment. Whole body mole mapping consists of periodic photography of patients, typically those at high risk for developing melanoma. The pictures are reviewed clinically. This service is provided at some diagnostic imaging centers and dermatology offices. DigitalDerm, Inc. offers a computerized system for acquisition, storage, and review of the pictures.
      Dermoscopy, or epiluminescence microscopy, allows for non-invasive visualization of colors and microstructures of the epidermis, the dermal-epidermal junction, and the papillary dermis not visible to the naked eye. Manufacturers of dermoscopes include (but are not limited to) Welch Allyn, Inc. (US), Heine Optotechnik (Germany), and 3Gen, LLC (US). Digital dermoscopes allow for dermoscopic images to be visualized on a computer screen at larger magnification. In addition, images may be stored and compared to images taken previously. Manufacturers of digital dermoscopes include (but are not limited to) Derma Medical Systems, Inc. (Austria), ZN Vision Technologies AG (Germany), Polartechnics, Ltd. (Australia), Linos Photonics, Inc. (Germany), and Biomips Engineering (Italy). Dermoscopy is a tool used by approximately 25% of dermatologists in the US and is associated with a long learning curve. Physicians experienced in the use of dermoscopy have been shown to have an increased diagnostic accuracy of 10 to 20% over clinical examination. Although some digital dermoscopes provide information regarding the probability that a lesion may be melanoma compared to a database of lesions, no system, to our knowledge, is under PMA development for objective interpretation.
      A recent published article describes the results of a study utilizing the DB-Mips system from Biomips Engineering. The database of lesions used in this study differs significantly from our proprietary database. For example, our database includes a substantial number of lesions such as seborrheic keratoses and pigmented basal cell carcinomas, which can be difficult to differentiate from melanoma. The DB-Mips database included none of these lesions. Further, our database includes many more melanomas that are minimally invasive as well as a much higher percentage of dysplastic nevi compared to the DB-Mips database. Minimally invasive melanomas are more difficult to diagnose than melanomas that have significantly invaded the skin, and dysplastic nevi can be very difficult to differentiate from melanoma. Thus, we believe that the DB-Mips database does not include as many pigmented lesions that are difficult to differentiate from melanoma as our database. This is further confirmed by the fact that the specificity of dermatologists in other DB-Mips studies was reported to be over 80% while the specificity of dermatologists in MelaFind® studies is typically under 30%. The DB-Mips system has a reported specificity of up to 79%, which is roughly equivalent to the specificity of the dermatologists in DB-Mips studies. The DB-Mips system has a reported sensitivity to melanoma of about 95%. We believe that because the DB-Mips database includes relatively few early melanomas, direct comparison with MelaFind®’s sensitivity is not meaningful.
      Spectrophotometric intercutaneous analysis is a technique of visualizing collagen, blood, and pigment. Astron Clinica (UK) manufactures a device utilizing this technique. Confocal microscopy is an

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experimental approach for non-invasive visualization of skin structures at the cellular level; such a device utilizing this technique is in development by Lucid (US).
      A spectrophotometer (an instrument for measuring absorption of light of different wavelengths) is offered by Medical High Technologies S.p.A. (Switzerland). In contrast to MelaFind®, the product does not perform automatic quality control of images and has an external light source. We believe that the reported sensitivity of 80.4% would not gain market approval. Further, we are not aware of comparative data on physicians’ performance in corresponding data sets. The system does not have PMA approval, nor are we aware of efforts directed to obtain PMA approval of the product.
      The broad market for precision optical imaging devices used for medical diagnosis is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants. If our products are approved for marketing, we will potentially be subject to competition from major optical imaging companies, such as General Electric Co., Siemens AG, Bayer AG, Eastman Kodak Company, Olympus Corporation, Carl Zeiss AG Deutschland and others, each of which manufactures and markets precision optical imaging products for the medical market and could decide to develop or acquire a product to compete with MelaFind®.
Manufacturing
      We are currently focusing our manufacturing efforts on hardware engineering in order to make the functioning of the MelaFind® hand-held imaging devices more consistent and robust, and to facilitate larger-scale manufacturing methods of the pre-commercialization devices that will be used in the pivotal clinical trial. Data from the clinical studies as well as from engineering tests under stress and different environmental conditions are being used to refine appropriate manufacturing and field specifications before the design is fixed.
      For this crucial phase in development, we have contracted with a third-party vendor, ASKION (Gera, Germany), which specializes in precision optics. The pre-commercialization hand-held imaging devices to be assembled by ASKION are expected to be available for pivotal trial initiation planned for early 2006. The pre-commercialization hand-held imaging devices are expected to be more robust while having at least the same or better performance than the hand-held imaging devices used in the clinical program to date.
      We have recently been inspected by the FDA for the manufacturing and commercialization of DIFOTI®, our dental cavities detection product that has been discontinued for business reasons. The FDA inspectors observed deficiencies that were documented on FDA Form 483 that was issued to us following the inspection. We have had a follow-up meeting with the FDA and are working with the FDA and consultants to address the inspectional findings, particularly as they relate to current MelaFind® design development and ultimate MelaFind® commercial manufacturing. We believe that the issues can be addressed to the satisfaction of the FDA and will not materially adversely effect our operations.
Research and Development Efforts
      Our research and development efforts are currently focused on finalization and validation of the pre-commercialization hand-held imaging device, and completion of the development of the MelaFind® Lesion Classifiers. To date, we have developed and tested four-step classifiers (see “Results of Training Studies and Blinded Tests”), and we are currently working on five-step versions. The classifiers have been trained on 113 melanomas to date, and our goal is to use 300 melanomas (and over 4,000 non-melanoma pigmented lesions) for training. To date we have collected over 225 melanomas, which are available for classifier training.
      We have engaged Battelle Memorial Institute to perform specific technical services supporting our algorithm and software development and other efforts.
      Our R&D plan also includes further improvements such as incorporating wireless technology and an internet connection for hand-held imaging device quality monitoring, as well as faster and easier software

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downloads for future software versions. The internet based monitoring of the performance of our hand-held imaging device, known as Intelligent Device Management, is intended to enable us to continuously monitor our hand-held imaging device, advise the user of errors in handling, and thus enhance customer satisfaction and loyalty.
      We have performed feasibility studies of a MelaFind® software add-on feature called MelaMetertm, an enhancement to MelaFind® that provides information regarding the depth of penetration of a pigmented skin lesion. This information may be useful to physicians in determining the necessary depth and breadth of biopsy of a pigmented skin lesion. Initial clinical studies of MelaMetertm demonstrate the ability of MelaMetertm to non-invasively estimate the Breslow thickness (the thickness of a cutaneous malignant melanoma measured from the epidermis to the deepest malignant cells present) comparably to histological examination of excised lesions. We plan to continue the development of MelaMetertm and seek its FDA approval after receiving PMA approval of MelaFind®.
      Following commercialization of MelaFind®, we intend to evaluate the potential use of our light based computer vision platform in other applications, including the non-invasive detection of basal cell carcinoma, the most common skin cancer. New hardware systems for the imaging of blood and blood vessel patterns are needed since the majority of basal cell carcinomas are not pigmented and, accordingly, the MelaFind® system as currently developed is not appropriate for this use. However, we believe MelaFind®’s software programs and algorithms will be applicable.
Intellectual Property
      Our policy is to protect our intellectual property by obtaining US and foreign patents to protect technology, inventions and improvements important to the development of our business. To date we have been awarded 14 US patents with numerous foreign counterparts, of which six US patents and two Australian patents relate to various aspects of MelaFind®. In addition, we have applied for two additional US patents and have filed certain foreign patent applications relating to MelaFind®, of which two foreign patent applications are currently in the European regional phase. Also, we have obtained non-exclusive licenses from several of our suppliers for critical components of MelaFind®. We have not granted any significant licenses with respect to our intellectual property.
      We cannot be certain that our patents will not be challenged or circumvented by competitors. Whether a patent is infringed and is valid, or whether a patent application should be granted, are all complex matters of science and law, and therefore we cannot be certain that, if challenged, our patents, patent applications and/or other intellectual property rights would be upheld. If one or more of those patents, patent applications and other intellectual property rights are invalidated, rejected or found unenforceable, that could reduce or eliminate any competitive advantage.
      We also rely on trade secrets and technical know-how in the manufacture and marketing of MelaFind®. We require our employees, consultants and contractors to execute confidentiality agreements with respect to our proprietary information.
      We have obtained US trademark registrations for the following marks: “MelaFind®” and “DIFOTI®,” as well as the corporate logo for “eos-electro-optical sciences, inc.®” The goods covered by these registrations are in International Class 010 and US Classes 26, 39 and 44. For MelaFind®, the description of goods and services covered by the trademark is: “medical devices, namely, electro-optical devices incorporating hardware for obtaining images in different spectral bands and software for analyzing the images for use in analyzing skin lesions and determining the existence of melanoma.” For DIFOTI®, the description of goods and services covered by the trademark is: “electro-optical apparatus to diagnose dental conditions.” For “eos-electro-optical sciences, inc.®,” the description of goods and services covered by the trademark is: “instrumentation comprising computer assisted optical imagers and image analyzers for use in the detection of dental cavities, cutaneous melanoma, and other pathologies of the teeth, skin and other tissues.” We also have registered the internet domain names: www.eo-sciences.com, www.eosciences.com, www.melafind.com, www.difoti.com, www.smartlightsensors.com, and www.skinsurf.com.

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      The following table lists the fundamental US patents that cover the MelaFind® methodology, apparatus, and systems:
US Patents Relating to MelaFind®
                     
Patent #   Title   Issued   Expiration
             
6,081,612
  Systems and Methods for the Multispectral Imaging and     06/27/00       02/27/17  
    Characterization of Skin Tissue                
6,208,749
  Systems and Methods for the Multispectral Imaging and     03/27/01       02/27/17  
    Characterization of Skin Tissue                
6,307,957
  Multispectral Imaging and Characterization of Biological Tissue     10/23/01       02/27/17  
6,626,558
  Apparatus for Uniform Illumination of an Object     09/30/03       08/31/21  
6,657,798
  Method for Optimizing the Number of Good Assemblies     12/02/03       02/10/23  
    Manufacturable From a Number of Parts                
6,710,947
  Method for Assembling Lens Elements     03/23/04       02/27/23  
      The first two listed patents improve the specificity and sensitivity of the software algorithms that classify lesions as suspicious for melanoma or as not suspicious. The third patent extends the prior patents for potential use in evaluating gastro-intestinal lesions. The fourth patent covers a novel way of providing illumination with which to capture images. The fifth and sixth patents describe cost-saving methods of lens assembly. We believe that our patented methods and apparatus, together with unpatented related trade-secret technology, give us a competitive advantage; however, we cannot be certain that, if challenged, our patented methods and apparatus and/or trade-secret technology would be upheld. If one or more of our patented methods, patented apparatus or trade secret technology rights are invalidated, rejected or found unenforceable, that could reduce or eliminate any competitive advantage we might otherwise have had.
      US patent No. 6,081,612 relates to the MelaFind® system and methods employed in building MelaFind® classification algorithms involving the use of novel multi-spectral lesion features by means of wavelet maxima representations. Wavelet maxima representations use specific types of mathematical transformations called wavelets to represent a signal, such as an image of a lesion taken by the MelaFind® system, at different detail levels. The wavelet maxima representation retains information of potential diagnostic value. This information is quantified in the form of statistical features used for automatic classification. Patent No. 6,208,749 relates to methods employed in building MelaFind® classification algorithms involving the use of novel features of multispectral lesion images that do not involve the use of wavelet transformations to determine whether the lesion is or is not a melanoma. We believe the inclusion of the described wavelets and non-wavelets features improves significantly the sensitivity and specificity of the melanoma classifiers. Patent No. 6,307,957 extends the use of the novel features of the MelaFind® system to endoscopy (examination of gastro-intestinal tissues using fiber-optic probes). We have no present plans to develop endoscopy applications of our technology.
      Patent 6,626,558 covers the array of numerous light-emitting diodes (LED’s) that are used in the MelaFind® hand-held device to provide uniform illumination of lesions in multiple spectral bands of illumination. Patent 6,657,798 involves the use of a computer algorithm to optimize the number of lens assemblies possible from a given number of sets of lens elements. Patent 6,710,947 describes a method for the economical assembly of the nine elements of the MelaFind® hand-held device’s optical lens apparatus.
      We also have developed trade secret calibration methods, classifier programs, and search engines; these programs have been developed over many years and incorporate decades of experience in optical computer vision. In addition, our proprietary MelaFind® database of over 5,000 lesions has been compiled over a number of years and would be difficult to replicate.

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FDA Regulation
      Our product, MelaFind®, is regulated as a medical device and is subject to extensive regulation by the FDA and other regulatory authorities in the US. The FD&C Act and other federal and state statutes and regulations govern the research, design, development, preclinical and clinical testing, manufacturing, safety, approval or clearance, labeling, packaging, storage, record keeping, servicing, promotion, import and export, and distribution of medical devices.
      Unless an exemption applies, each medical device we wish to commercially distribute in the US will require either prior premarket notification, or 510(k) clearance, or PMA approval, from the FDA. The FDA classifies medical devices into one of three classes. Devices requiring fewer controls because they are deemed to pose lower risk are placed in Class I or II. Class I devices are subject to general controls such as labeling, premarket notification, and adherence to the FDA’s QSR. Class II devices are subject to special controls such as performance standards, postmarket surveillance, FDA guidelines, as well as general controls. Some Class I and Class II devices are exempted by regulation from the premarket notification, or 510(k), clearance requirement or the requirement of compliance with certain provisions of the QSR. Devices are placed in Class III, which requires approval of a PMA application, if insufficient information exists to determine that the application of general controls or special controls are sufficient to provide reasonable assurance of safety and effectiveness, or they are life-sustaining, life-supporting or implantable devices, or the FDA deems these devices to be “not substantially equivalent” either to a previously 510(k) cleared device or to a “preamendment” Class III device in commercial distribution before May 28, 1976, for which PMA applications have not been required. The FDA classifies MelaFind® as a Class III device, requiring PMA approval.
      A PMA application must be supported by valid scientific evidence, which typically requires extensive data, including technical, pre-clinical, clinical, manufacturing and labeling data, to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device. A PMA application must include, among other things, a complete description of the device and its components, a detailed description of the methods, facilities and controls used to manufacture the device, and proposed labeling. A PMA application also must be accompanied by a user fee, unless exempt. For example, the FDA does not require the submission of a user fee for a small business’s first PMA. After a PMA application is submitted and found to be sufficiently complete, the FDA begins an in-depth review of the submitted information. During this review period, the FDA may request additional information, or clarification of information already provided. Also during the review period, the FDA has informed us that an advisory panel of experts from outside the FDA will be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. In addition, the FDA generally will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with the QSR, which requires manufacturers to follow design, testing, control, documentation and other quality assurance procedures.
      We commenced the PMA application process for MelaFind® by filing a proposed Shell (an outline of a PMA) for a three module PMA on September 30, 2002. We filed as a Small Business Entity exempt from the user fee requirement. The Shell was accepted and two Modules have been filed and reviewed. The third Module will include the results of the pivotal clinical study, and cannot be filed until after that study is complete and its results have been evaluated. The FDA can delay, limit or deny approval of a PMA application for many reasons, including:
  •  MelaFind® may not be safe or effective to the FDA’s satisfaction;
 
  •  the data from our pre-clinical studies and clinical trials may be insufficient to support approval;
 
  •  the manufacturing process or facilities we use may not meet applicable requirements; and
 
  •  changes in FDA approval policies or adoption of new regulations may require additional data.
      If the FDA evaluations of both the PMA application and the manufacturing facilities are favorable, the FDA will either issue an approval letter, or approvable letter, which usually contains a number of conditions which must be met in order to secure final approval of the PMA. When and if those conditions

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have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing commercial marketing of the device for certain indications. If the FDA’s evaluation of the PMA or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not approvable letter. The FDA may also determine that additional clinical trials are necessary, in which case the PMA approval may be delayed while the trials are conducted and the data acquired is submitted in an amendment to the PMA. Even with additional trials, the FDA may not approve the PMA application. The PMA process can be expensive, uncertain and lengthy and a number of devices for which FDA approval has been sought by other companies have never been approved for marketing.
      New PMA applications or PMA supplements may be required for modifications to the manufacturing process, labeling and device specifications, materials or design of a device that is approved through the PMA process. PMA supplements often require submission of the same type of information as an initial PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application, and may not require as extensive clinical data or the convening of an advisory panel.
      Clinical trials are almost always required to support a PMA application, and are sometimes required for a 510(k) clearance. These trials generally require submission of an application for an IDE to the FDA. We have not been required to file an IDE application for the MelaFind® clinical studies because FDA has considered the trials “non-significant risk” (NSR) studies subject to abbreviated IDE regulations, which do not require formal IDE submission. An IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE application must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a non-significant risk device and eligible for more abbreviated IDE requirements. Generally, clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the study protocol and informed consent form are approved by appropriate institutional review boards at the clinical trial sites. The FDA’s approval of an IDE allows clinical testing to go forward, but does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and effectiveness, even if the trial meets its intended success criteria. All clinical trials must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. As stated above, the clinical studies of MelaFind® are considered by the FDA as NSR. Consequently, the trials are conducted under the auspices of an abbreviated IDE. Clinical trials must further comply with the FDA’s regulations for IRB approval and for informed consent. Required records and reports are subject to inspection by the FDA. The results of clinical testing may be unfavorable or, even if the intended safety and effectiveness success criteria are achieved, may not be considered sufficient for the FDA to grant approval or clearance of a product. The commencement or completion of any of our clinical trials may be delayed or halted, or be inadequate to support approval of a PMA application, or 510(k) clearance, for numerous reasons, including, but not limited to, the following:
  •  the FDA, other regulatory authorities, or an IRB do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;
 
  •  patients do not enroll in clinical trials at the rate we expect;
 
  •  physicians do not comply with trial protocols;
 
  •  patient follow-up is not at the rate we expect;
 
  •  patients experience adverse events;
 
  •  IRBs and third-party clinical investigators may delay or reject our trial protocol;
 
  •  third-party clinical investigators decline to participate in a trial or do not perform a trial on our anticipated schedule or consistent with the clinical trial protocol, GCPs or other FDA requirements;

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  •  third-party organizations do not perform data collection and analysis in a timely or accurate manner;
 
  •  regulatory inspections of our clinical trials or manufacturing facilities may, among other things, require us to undertake corrective action or suspend or terminate our clinical trials, or invalidate our clinical trials;
 
  •  changes in governmental regulations or administrative actions; and
 
  •  the interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness.
      Our clinical trials may not generate favorable data to support any PMA applications, and we may not be able to obtain such approvals on a timely basis, or at all. Delays in receipt of or failure to receive such approvals, the withdrawal of previously received approvals, or failure to comply with existing or future regulatory requirements would have a material adverse effect on our business, financial condition and results of operations. Even if granted, the approvals may include significant limitations on the intended use and indications for use for which our products may be marketed.
      After a device is approved or cleared and placed in commercial distribution, numerous regulatory requirements apply. These include:
  •  establishment registration and device listing;
 
  •  QSR, which requires manufacturers to follow design, testing, control, documentation and other quality assurance procedures;
 
  •  labeling regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;
 
  •  medical device reporting regulations, which require that manufacturers report to the FDA if a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; and
 
  •  corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act that may present a risk to health.
      Also, the FDA may require us to conduct postmarket surveillance studies or order us to establish and maintain a system for tracking our products through the chain of distribution to the patient level. The FDA enforces regulatory requirements by conducting periodic, unannounced inspections and market surveillance. Inspections may include the manufacturing facilities of our subcontractors. Thus, we must continue to spend time, money, and effort to maintain compliance.
      Failure to comply with applicable regulatory requirements, including those applicable to the conduct of our clinical trials, can result in enforcement action by the FDA, which may lead to any of the following sanctions:
  •  warning letters;
 
  •  fines and civil penalties;
 
  •  unanticipated expenditures;
 
  •  delays in approving or refusal to approve our applications, including supplements;
 
  •  withdrawal of FDA approval;
 
  •  product recall or seizure;
 
  •  interruption of production;
 
  •  operating restrictions;

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  •  injunctions; and
 
  •  criminal prosecution.
      We and our contract manufacturers, specification developers, and some suppliers of components, are also required to manufacture our products in compliance with cGMP requirements set forth in the QSR. The QSR requires a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and includes extensive requirements with respect to quality management and organization, device design, equipment, purchase and handling of components, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing, and record keeping. The FDA enforces the QSR through periodic unannounced inspections that may include the manufacturing facilities of our subcontractors. We expect that our manufacturing facility and those of our subcontractors will be subject to domestic and international regulatory inspection and review. If the FDA believes we or any of our contract manufacturers or regulated suppliers are not in compliance with these requirements, it can shut down our manufacturing operations, require recall of our products, refuse to approve new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations, or assess civil and criminal penalties against us or our officers or other employees. Any such action by the FDA would have a material adverse effect on our business. We cannot assure you that we will be able to comply with all applicable FDA regulations.
Government Regulation
      The advertising of our MelaFind® product will be subject to both FDA and Federal Trade Commission regulations. In addition, the sale and marketing of MelaFind® will be subject to a complex system of federal and state laws and regulations intended to deter, detect, and respond to fraud and abuse in the healthcare system. These laws and regulations restrict and may prohibit pricing, discounting, commissions and other commercial practices that may be typical outside of the healthcare business. In particular, anti-kickback and self-referral laws and regulations will limit our flexibility in crafting promotional programs and other financial arrangements in connection with the sale of our products and related services, especially with respect to physicians seeking reimbursement through Medicare or Medicaid. These federal laws include, by way of example, the following:
  •  the anti-kickback statute prohibits certain business practices and relationships that might affect the provision and cost of healthcare services reimbursable under Medicare, Medicaid and other federal healthcare programs, including the payment or receipt of remuneration for the referral of patients whose care will be paid by Medicare or other federal healthcare programs;
 
  •  the physician self-referral prohibition, commonly referred to as the Stark Law, which prohibits referrals by physicians of Medicare or Medicaid patients to providers of a broad range of designated healthcare services in which the physicians or their immediate family members have ownership interests or with which they have certain other financial arrangements;
 
  •  the anti-inducement law, which prohibits providers from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use items or services covered by either program;
 
  •  the Civil False Claims Act, which prohibits any person from knowingly presenting or causing to be presented false or fraudulent claims for payment by the federal government, including the Medicare and Medicaid programs; and
 
  •  the Civil Monetary Penalties Law, which authorizes HHS to impose civil penalties administratively for fraudulent or abusive acts.
      Sanctions for violating these federal laws include criminal and civil penalties that range from punitive sanctions, damage assessments, money penalties, imprisonment, denial of Medicare and Medicaid payments, or exclusion from the Medicare and Medicaid programs, or both. These laws also impose an affirmative duty on those receiving Medicare or Medicaid funding to ensure that they do not employ or contract with persons excluded from the Medicare and other government programs.

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      Many states have adopted or are considering legislative proposals similar to the federal fraud and abuse laws, some of which extend beyond the Medicare and Medicaid programs to prohibit the payment or receipt of remuneration for the referral of patients and physician self-referrals regardless of whether the service was reimbursed by Medicare or Medicaid. Many states have also adopted or are considering legislative proposals to increase patient protections, such as limiting the use and disclosure of patient-specific health information. These state laws typically impose criminal and civil penalties similar to the federal laws.
      In the ordinary course of their business, medical device manufacturers and suppliers have been and are subject regularly to inquiries, investigations and audits by federal and state agencies that oversee these laws and regulations. Recent federal and state legislation has greatly increased funding for investigations and enforcement actions, which have increased dramatically over the past several years. This trend is expected to continue. Private enforcement of healthcare fraud also has increased, due in large part to amendments to the Civil False Claims Act in 1986 that were designed to encourage private persons to sue on behalf of the government. These whistleblower suits by private persons, known as qui tam relators, may be filed by almost anyone, including physicians and their employees and patients, our employees, and even competitors. HIPAA, in addition to its privacy provisions, created a series of new healthcare-related crimes.
Environmental Regulation
      Our research and development and clinical processes involve the handling of potentially harmful biological materials as well as hazardous materials. We and our investigators and vendors are subject to federal, state and local laws and regulations governing the use, handling, storage and disposal of hazardous and biological materials and we incur expenses relating to compliance with these laws and regulations. If violations of environmental, health and safety laws occur, we could be held liable for damages, penalties and costs of remedial actions. These expenses or this liability could have a significant negative impact on our financial condition. We may violate environmental, health and safety laws in the future as a result of human error, equipment failure or other causes. Environmental laws could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We are subject to potentially conflicting and changing regulatory agendas of political, business and environmental groups. Changes to or restrictions on permitting requirements or processes, hazardous or biological material storage or handling might require an unplanned capital investment or relocation. Failure to comply with new or existing laws or regulations could harm our business, financial condition and results of operations.
International Regulation
      International sales of medical devices are subject to foreign government regulations, which may vary substantially from country to country from having no regulations to having a premarket notice or premarket acceptance. The time required to obtain approval in a foreign country may be longer or shorter than that required for FDA approval, and the requirements may differ. There is a trend towards harmonization of quality system standards among the European Union, US, Canada and various other industrialized countries.
      The European Union, which includes most of the major countries in Europe, has adopted numerous directives and standards regulating the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices. Devices that comply with the requirements of a relevant directive will be entitled to bear the CE conformity marking, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, can be commercially distributed throughout Europe. The method of assessing conformity varies depending on the class of the product, but normally involves a combination of self-assessment by the manufacturer and a third party assessment by a “Notified Body.” This third party assessment may consist of an audit of the manufacturer’s quality system and specific testing of the manufacturer’s product. An assessment by a Notified Body of one country within the European Union is required in order for a manufacturer to commercially distribute the product throughout

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the European Union. As part of the CE compliance, manufacturers are required to comply with the ISO 9000 series of standards for quality operations (an international standard for quality management requirements maintained by the International Organization for Standardization (ISO)). Other countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the European Union with respect to medical devices. Outside of the European Union, regulatory approval needs to be sought on a country-by-country basis in order for us to market our products.
Product Liability and Insurance
      Our business exposes us to the risk of product liability claims that is inherent in the testing, manufacturing and marketing of medical devices, including those which may arise from the misuse or malfunction of, or design flaws in, our products. We may be subject to product liability claims if MelaFind® causes, or merely appears to have caused, an injury. Claims may be made by patients, healthcare providers or others involved with MelaFind®. MelaFind® will require from the FDA approval prior to commercialization in the US. The clinical studies of MelaFind® are considered by the FDA as NSR. Consequently, the trials are conducted under the auspices of an abbreviated IDE. We therefore do not maintain domestic clinical trial liability insurance. We have placed clinical trial liability insurance in certain European countries where required by statute or clinical site policy. Although we have general liability insurance that we believe is appropriate, and anticipate obtaining adequate product liability insurance before commercialization of MelaFind®, this insurance is and will be subject to deductibles and coverage limitations. Our anticipated product liability insurance may not be available to us in amounts and on acceptable terms, if at all, and, if available, the coverages may not be adequate to protect us against any future product liability claims. If we are unable to obtain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may harm our business.
Employees
      As of June 30, 2005, we had 27 full-time and two part-time employees, of whom 13 were engaged in research and development (including clinical and regulatory affairs), seven in production (including document control and quality assurance) and nine in marketing, sales and administrative activities. We believe that our relationship with our employees is good.
Facilities
      We lease approximately 2,800 square feet of office space at 3 West Main Street, Suite 201, Irvington, New York, and an additional 3,700 square feet of office, laboratory, and assembly space in an adjacent building with the street address of 1 Bridge Street, Suite 15, Irvington, New York. The lease on the 2,800 square feet of space expires in November 2010. The lease on the 3,700 square feet of space expires in June 2009. We believe that these facilities are adequate to meet our current and reasonably foreseeable requirements. We believe that we will be able to obtain additional space, if required, on commercially reasonable terms.
Legal Proceedings
      We are not currently a party to any legal proceedings.
Discontinued Business
      As of April 5, 2005, we decided to discontinue all operations associated with our DIFOTI® product, a non-invasive imaging device for the detection of dental cavities, in order to focus our resources on the development and commercialization of MelaFind®. We are currently seeking an acquirer for the DIFOTI® assets. Once a disposition relating to the DIFOTI® assets is complete, we do not expect to have any significant continuing responsibility for the DIFOTI® business.

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MANAGEMENT
Executive Officers and Directors
      The following table sets forth the names, ages as of June 30, 2005 and a brief account of the business experience of each person who is a current executive officer or director of our company and each person who has been elected to serve as a director effective upon the close of this offering. Each director of our company will hold office until the next annual meeting of shareholders of our company or until his successor has been elected and qualified.
             
Name   Age   Position
         
Joseph V. Gulfo, M.D. 
    42     Director, President and Chief Executive Officer
Karen Krumeich
    51     Vice President, Finance, Chief Financial Officer and Treasurer
Jon I. Klippel
    50     Vice President, Marketing and Sales
William R. Bronner
    59     Vice President, Legal Counsel and Compliance
Breaux Castleman(1)(2)
    64     Director, Chairman of the Board of Directors
Sidney Braginsky(1)
    68     Director
George C. Chryssis(1)
    58     Director
Martin D. Cleary(2)(3)(4)
    59     Director Elect
Dan W. Lufkin(2)(3)
    73     Director
Gerald Wagner, Ph.D. 
    62     Director
 
(1)  Member of Compensation Committee
 
(2)  Member of Nominating and Governance Committee
 
(3)  Member of Audit Committee
 
(4)  Director elected to serve effective as of the completion of this offering
Executive Officers
      Joseph V. Gulfo, M.D., M.B.A. has served as our President and Chief Executive Officer and a member of our board of directors since January 2004. From May 1999 to November 2004, he served as Chairman, Chief Executive Officer and President of Antigen Express, Inc., a development-stage company developing immunodiagnostics and therapeutics for cancer. Dr. Gulfo serves as a director of ProCertus BioPharm, Inc., a privately-held company. Dr. Gulfo received a B.S. in Biology from Seton Hall University, an M.D. from the University of Medicine and Dentistry of New Jersey and an M.B.A. in Finance from Seton Hall University.
      Karen Krumeich has served as our Vice President, Finance and Chief Financial Officer since January 2005 and Treasurer since May 2005. From August 2004 to January 2005 she served as a financial consultant with Horn Murdock Cole, a financial consulting firm. From September 2002 to July 2004, she served as divisional Chief Financial Officer of the hospital group division of Henry Schein, Inc., a publicly-held medical and dental products distributor. From March 2000 to August 2002, she served as a financial consultant with Consulting Associates, a financial consulting firm. Ms. Krumeich received her B.S. in Pharmacy from the University of Toledo College of Pharmacy and completed additional coursework in accounting at Cleveland State University.
      Jon I. Klippel has served as our Vice President, Marketing and Sales since December 2004. From April 2004 to November 2004, he was a marketing and sales consultant. From January 2003 to March 2004, he served as Senior Marketing Manager of PDI, Inc., a publicly-traded company offering outsourced marketing, sales and sale support services to biopharmaceutical and medical device companies. From February 2002 to December 2002, he was a marketing and sales consultant. From July 2000 to February 2002, he served as Director of Marketing and Business Development at National Imaging Associates, Inc.,

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a privately-held diagnostic imaging management company. Mr. Klippel received a B.A. in Political Science from Albright College and an M.B.A. from Rutgers University Graduate School of Business.
      William R. Bronner has served as our Vice President, Legal Counsel and Compliance since July 2000 and as our Secretary since May 2002. From 1986 to July 2000, Mr. Bronner served as Vice President, General Counsel and Secretary of Kronos, Inc. Mr. Bronner received a B.A. in Government from Dartmouth College and a J.D. from Columbia University Law School.
      Our executive officers are elected by, and serve at the discretion of our board of directors. There are no family relationships between our directors and executive officers.
Non-Executive Directors
      Breaux Castleman has served as a member of our board of directors and Chairman of our board since July 2003. Since August 2001, he has served as President, Chief Executive Officer and Chairman of Syntiro Healthcare Services, Inc. Mr. Castleman also serves as a director of FemPartners, Inc., Integrated Diagnostic Centers, Inc. and Radiology Practice Management, Inc., each of which are privately-held companies. From December 1999 to July 2001, he served as Chief Executive Officer of Physia Corp. He served as President of Scripps Clinic from July 1996 to October 1999. He holds a B.A. in economics from Yale University and attended New York University Graduate School of Business Administration.
      Sidney Braginsky has served as a member of our board of directors since 2001. He also currently serves as the Chairman and Chief Executive Officer of Digilab, LLC (a spectroscopy instruments manufacturer), Chief Executive Officer and President of Ineedmd, Ltd., Chairman of Double D Venture Fund, LLC, Chairman of the Board of the City University of New York Robert Chambers Laboratory and Trustee on the Boards of Long Island High Tech Incubator and the Long Island Museum of Science and Technology. He formerly served as President of Olympus America and Mediscience Corp., Chairman of Atropos Technologies, LLC and International Standards Organization Optics, and a director for Noven Pharmaceuticals, Inc. Mr. Braginsky received his B.S. in biology from Queens College.
      George C. Chryssis has served as a member of our board of directors since 2001. Since 2003, he has served as President, Chief Executive Officer and Chairman of the Board of MISTsoft Corp., a privately-held software company which he founded. Since 2000, he has served as the Managing Member of Arcadian Capital Management, LLC, and General Partner of Arcadian Venture Partners, LP, a venture capital firm with investments in early stage technology companies, including EOS. Since 2003, he has also served as Chairman of the Board of Directors of DelCom Corp., a privately-held telecommunications software company. Mr. Chryssis received a B.S. and M.S. in electrical engineering from Northeastern University.
      Martin D. Cleary will become a member of our board of directors upon completion of this offering. Since February 2003, he has served as the President and Chief Executive Officer of Juvaris Biotherapeutics, Inc., a company engaged in the development of therapeutic vaccines for cancer and infectious diseases. From September 1999 to May 2002, he served as the President and Chief Executive Officer of Genteric, Inc., a company engaged in non-viral gene delivery. Mr. Cleary received a B.S. in accounting from Rutgers University in 1971, and a certificate in international studies from Columbia University in 1973.
      Dan W. Lufkin has served as a member of our board of directors since July 2003. He is also a co-founder and former Chairman of the investment banking firm, Donaldson, Lufkin & Jenrette, Inc. Mr. Lufkin currently serves as a consultant to and/or board member of a number of private companies and non-profit endeavors. Mr. Lufkin received a B.A. degree from Yale University and an M.B.A. from Harvard Business School.
      Gerald Wagner, Ph.D. was appointed as a member of our board of directors in May 2005. Since 2002, he has owned and operated Gerald Wagner Consulting LLC, an international consulting company specializing in: international project management; technology and application consulting; and company assessments. From March 1992 to September 2003, he was a Senior Vice President, Lab Testing Systems, at Bayer, Inc. Mr. Wagner received a Masters and Ph.D. in electro-mechanical design from Technical University, Darmstadt, Germany.

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Board of Directors Composition
      Our current charter documents and the charter documents we expect to be in effect upon completion of this offering authorize up to nine (9) directors. We currently have six (6) directors and expect to have seven (7) directors upon completion of the initial public offering. Joseph V. Gulfo, M.D., Breaux Castleman, Dan W. Lufkin and George C. Chryssis were elected pursuant to voting provisions contained in a voting agreement that we entered into with certain holders or our common stock and preferred stock. Upon the closing of this offering, the voting agreement will be terminated and none of our stockholders will have any special rights regarding board representation. See “Related Party Transactions — Voting Agreement” for additional information regarding the voting agreement.
Board Committees
      Audit Committee. The current members of our audit committee are Messrs. Braginsky and Lufkin, each of whom we believe satisfies the independence requirements of the NASDAQ National Market and the SEC. Mr. Cleary will join the audit committee upon completion of the offering and will chair the committee. We believe Mr. Cleary satisfies the independence requirements of the NASDAQ National Market and the SEC. In addition, we believe Mr. Cleary is qualified as an audit committee financial expert under the regulations of the SEC, and has the accounting and related financial management expertise required by the NASDAQ National Market. Our audit committee assists our board in its oversight of:
  •  the integrity of our financial statements;
 
  •  our independent registered public accounting firm’s qualifications and independence; and
 
  •  the performance of our independent auditors.
      The audit committee has the sole and direct responsibility for appointing, evaluating and retaining our independent registered public accounting firm and for overseeing their work. All audit services to be provided to us and all non-audit services, other than de minimis non-audit services, to be provided to us by our independent auditors must be approved in advance by our audit committee.
      Compensation Committee. The members of our compensation committee are Messrs. Castleman, Braginsky and Chryssis, each of whom we believe satisfies the independence requirements of the NASDAQ National Market and the SEC. Mr. Castleman chairs this committee. The purpose of our compensation committee is to discharge the responsibilities of our board of directors relating to compensation of our executive officers. Specific responsibilities of our compensation committee include:
  •  reviewing and recommending compensation of our executive officers;
 
  •  administering our stock incentive plans; and
 
  •  reviewing and recommending incentive compensation and equity plans.
      Nominating and Governance Committee. The members of our nominating and governance committee are Messrs. Lufkin and Castleman, each of whom we believe satisfies the independence requirements of the NASDAQ National Market. Mr. Lufkin will chair this committee. Mr. Cleary will join the nominating and governance committee upon completion of the offering. Our nominating and governance committee:
  •  identifies and recommends nominees for election to our board of directors;
 
  •  develops and recommends our corporate governance principles; and
 
  •  oversees the evaluation of our board of directors and management.
Compensation Committee Interlocks and Insider Participation
      We did not have a compensation committee until May 2005. Dr. Gulfo, our Chief Executive Officer, previously participated in the deliberations regarding executive compensation. None of our executive officers has served as a member of the compensation committee, or other committee serving an equivalent function, of any other entity, one of whose executive officers served as a member of our compensation committee.

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Election of Directors
      The number of directors is determined by the stockholders at their annual meeting, subject to the right of the stockholders to change such number between annual meetings and to the right of our board to increase such number between annual meetings.
Director Compensation
      After completion of this offering, in addition to reimbursement of expenses incurred in attending meetings of our board of directors and committees of our board, our non-employee directors will receive an annual fee of $10,000 for serving as directors and an additional $500 per meeting for each meeting attended, whether in person or by telephone. In addition, after completion of this offering, the chairman of our board of directors, the chairman of our audit committee and the chairman of our nominating and governance committee will each receive an annual fee of $10,000. After completion of this offering, each member of our board who is not a company employee will receive an annual stock option grant to purchase up to 5,000 shares of common stock. Such stock options will vest in full upon the first anniversary of issuance and have an exercise price equal to the fair market value of our common stock on the date of the grant. In addition, we reimburse each member of our Board who is not a company employee for reasonable travel and other expenses in connection with attending meetings of the Board.
Scientific and Medical Advisory Committee
      We have established a Scientific and Medical Advisory Committee made up of leading experts in the fields of dermatology and oncology. Members of our Scientific and Medical Advisory Committee consult with us regularly on matters relating to:
  •  our research and development programs;
 
  •  the design and implementation of our clinical trials;
 
  •  market opportunities from a clinical perspective;
 
  •  new technologies relevant to our research and development programs; and
 
  •  scientific and technical issues relevant to our business.
      The current members of our Scientific and Medical Advisory Committee are:
     
Name   Professional Affiliation
     
Jeffrey P. Callen, M.D.
  Professor and Chief of the Division of Dermatology, University of Louisville School of Medicine; Member of the Board of Directors of the American Board of Dermatology, Inc.
Armand B. Cognetta, Jr., M.D.
  Dermatologist in private practice with Dermatology Associates of Tallahasee; Member, American Academy of Dermatology; former President of Florida Society of Dermatology; former President of Dermatology Photography Society.
Robert Friedman, M.D.
  Clinical Assistant Professor, Department of Dermatology, New York University School of Medicine; Past Director, American Cancer Society, New York City Division, and Member, Professional Education Committee; American Academy of Dermatology: Member, Skin Cancer/ Melanoma Committee, Past Chairman, Industry Liaison Committee.

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Name   Professional Affiliation
     
Martin C. Mihm, Jr., M.D., Chairman
  Professor and Chief of Dermatopathology at Harvard Medical School; Chief of Dermatopathology at Massachusetts General Hospital; Co-Director of the Pigmented Skin Lesion Clinic at Massachusetts General Hospital; Co-Chairman of the Melanoma Pathology Program of the World Health Organization; Co-Director of the Rare Tumor Institute of the World Health Organization; member of the editorial and advisory board of the American Journal of Dermatopathology and the International Journal of Surgical Pathology; Member of the American Academy of Dermatology; New England Pathology Society; American Society of Dermatopathology; American Society of Clinical Oncology; and College of American Pathologists.
Harold S. Rabinovitz, M.D.
  Dermatologist in private practice with Skin and Cancer Associates in Plantation, Florida; Voluntary Professor of Dermatology at the University of Miami-School of Medicine; Associate Editor of the Journal of Dermatologic Surgery; member of the Board of Directors of the South Florida Dermatology Foundation.
Darrell S. Rigel, M.D.
  Clinical Professor of Dermatology, New York University Medical Center; Secretary and Treasurer of the American Dermatological Association; Past President, American Academy of Dermatology; Member, Board of Directors of the American Cancer Society New York City Division and Chairman of its Subcommittee on Skin Cancer.
Arthur J. Sober, M.D.
  Professor of Dermatology, Harvard Medical School; Director of Dermatology Clinical Investigation Unit, Massachusetts General Hospital; Member, American Joint Commission on Cancer.
Medical Advisor and Liaison to Our Board of Directors
      Robert Friedman, M.D., a member of our Scientific and Medical Advisory Committee, serves as a medical advisor to our board of directors and a liaison between our Scientific and Medical Advisory Committee and our board of directors. See “Consulting Agreements — Consulting Agreement with Robert Friedman, M.D.”

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Executive Compensation
      The following table sets forth summary compensation information for the years ended December 31, 2002, December 31, 2003 and December 31, 2004 for our chief executive officer and each of our two other most highly compensated executive officers whose salary and bonus for 2004 was more than $100,000. As of December 31, 2004, there were no other persons serving as executive officers. We have also included summary compensation information for two executive officers who would have been among the four other most highly compensated executive officers whose salary and bonus for 2004 would have been more than $100,000 had they served as executive officers for the full year. We refer to these officers collectively as our named executive officers.
Summary Compensation Table
                                           
            Long Term    
        Annual Compensation   Compensation    
                 
            Securities    
            Underlying   All Other
Name and Principal Position   Year   Salary ($)   Bonus ($)   Options   Compensation
                     
Joseph V. Gulfo, M.D. 
    2004     $ 173,656             81,753 (1)   $ 19,880 (1)
  President and Chief     2003                          
  Executive Officer     2002                          
Marek Elbaum, Ph.D. 
    2004       173,549             10,000        
  Founder and former Chief Science     2003       81,085             29,071        
  and Technology Officer     2002       30,204                    
William Bronner
    2004       132,612             37,000        
  Vice President, Legal Counsel     2003       106,255             32,161        
  and Compliance     2002       26,444             1,875        
Karen Krumeich(2)
    2004                   60,000        
  Vice President Finance, Chief     2003                          
  Financial Officer     2002                          
Jon I. Klippel(3)
    2004       9,346             45,000        
  Vice President Marketing     2003                          
  and Sales     2002                          
 
(1)  Dr. Gulfo has been granted another stock option which is not reflected in this table because the number of shares purchasable under the option can only be calculated at the time of PMA approval of MelaFind®. The number of shares granted under this option is equal to that number of shares of our common stock equal to four percent of our fully-diluted capital stock at that time of PMA approval of MelaFind® minus 81,753 shares of our common stock. The exercise price of this option is $0.46 per share.
 
(2)  Ms. Krumeich’s employment with us began in January 2005 at an annual salary of $165,000.
 
(3)  Mr. Klippel’s employment with us began in December 2004 at an annual salary of $135,000.

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Stock Options Granted in 2004
      The following table provides information regarding stock options granted during 2004 to the named executive officers in that period. We have not granted any stock appreciation rights.
                                                 
                    Potential Realizable
                    Value of Assumed
                    Annual Rates of Stock
    Number of   % of Total Options           Price Appreciation for
    Securities   Granted to   Exercise or Base       Option Term(2)
    Underlying   Employees in   Price Per   Expiration    
Name   Options Granted   Fiscal Year   Share(1)   Date   5%   10%
                         
Joseph V. Gulfo, M.D.(3) 
    75,227       11.07 %   $ 0.46       2/02/09     $ 1,021,515     $ 1,298,088  
      6,526       0.09       0.46       2/02/09       88,617       112,610  
Marek Elbaum, Ph.D.(4)
    10,000       1.47       0.46       2/02/09       135,791       172,556  
Karen Krumeich
    60,000       8.82       0.46       12/17/09       814,746       1,035,337  
William R. Bronner
    17,000       2.50       0.46       2/02/09       230,845       293,345  
      20,000       2.94       0.46       12/17/09       271,582       345,112  
Jon I. Klippel
    45,000       6.62       0.46       12/17/09       611,059       776,502  
 
(1) Exercise price is equal to the fair market value on the date of grant as determined by our board of directors.
 
(2)  The dollar amounts under these columns are the result of calculations at rates set by the SEC and, therefore, are not intended to forecast possible future appreciation, if any, in the price of the underlying common stock. The potential realizable values are calculated using an assumed initial public offering price of $11.00 per share, the mid-point of our filing range, and assuming that the market price appreciates from this price at the indicated rate for the entire term of each option and that each option is exercised and sold on the last day of its term at the assumed appreciated price. Actual gains, if any, on stock option exercises depend on the future performance of the common stock and overall stock market conditions. The amounts reflected in the following table may not necessarily be achieved.
 
(3) Dr. Gulfo has been granted another stock option which is not reflected in this table because the number of shares purchasable under the option can only be calculated at the time of PMA approval of MelaFind®. The number of shares granted under this option is equal to that number of shares of our common stock equal to four percent of our fully-diluted capital stock at that time of PMA approval of MelaFind® minus 81,753 shares of our common stock.
(4)  Formerly our Chief Science and Technology Officer.
Aggregated Option Exercises in 2004 and Year-End Option Values
      The following table provides information about the number of shares issued upon option exercises by our named executive officers as of December 31, 2004 and the value realized by our named executive officers. The table also provides information about the number and value of options held by our named executive officers at December 31, 2004.
                                 
    Number of Unexercised    
    Securities Underlying   Value of Unexercised
    Options at   In-the-Money Options at
    December 31, 2004   December 31, 2004(1)
         
Name   Exercisable   Unexercisable   Exercisable   Unexercisable
                 
Joseph V. Gulfo, M.D.(2) 
    71,535       10,218     $ 753,979     $ 107,698  
Marek Elbaum, Ph.D.(3)
    14,070       25,000     $ 140,700     $ 264,400  
Karen Krumeich
    0       60,000     $     $ 632,400  
William R. Bronner
    49,160       21,875     $ 500,940     $ 229,469  
Jon I. Klippel
    0       45,000     $     $ 474,300  

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(1)  There was no public trading market for our common stock as of December 31, 2004. Accordingly, as permitted by the rules of the SEC, we have calculated the value of unexercised in-the-money options assuming an initial public offering price of $11.00 per share, the mid-point of our filing range, less the aggregate exercise price, without taking into account any taxes that might be payable in connection with the transaction.
 
(2)  Dr. Gulfo has been granted another stock option which is not reflected in this table because the number of shares purchasable under the option can only be calculated at the time of PMA approval of MelaFind®. The number of shares granted under this option is equal to that number of shares of our common stock equal to four percent of our fully-diluted capital stock at that time of PMA approval of MelaFind® minus 81,753 shares of our common stock.
 
(3)  Formerly our Chief Science and Technology Officer.
Equity Compensation Plans
2005 Stock Incentive Plan
      In 2005, we adopted our 2005 Stock Incentive Plan (2005 Plan). The 2005 Plan permits the granting of awards to key employees, directors, officers, consultants and scientific collaborators in the form of incentive or nonqualified stock options and equity-based awards. Stock options granted under the 2005 Plan may be “incentive stock options” meeting the requirements of Section 422 of the Code or nonqualified stock options, which do not meet the requirements of Section 422. Stock awards granted under the 2005 Plan to eligible participants may take the form of the issuance and transfer to the recipient of shares of common stock or a grant of stock units representing a future right to such shares of common stock. As of the date of this offering, there are 1,000,000 shares of our common stock authorized and reserved for issuance upon exercise of options which may be granted under the 2005 Plan and no options or other equity based awards have been issued under the 2005 Plan. Pursuant to the 2005 Plan on each of January 1, 2006 and January 1, 2007, the number of shares of common stock authorized for issuance will be automatically increased by an amount equal to 3% of the then outstanding shares of common stock unless the board decides to reduce the amount of the increase.
2003 Stock Incentive Plan
      In 2003, we adopted our 2003 Stock Incentive Plan, as amended (2003 Plan). The 2003 Plan permitted the granting of awards to our employees and other key persons (including directors, officers, consultants and scientific collaborations) in the form of restricted stock, and incentive or nonqualified stock options. Stock options granted under the 2003 Plan may be “incentive stock options” meeting the requirements of Section 422 of the Code or nonqualified stock options which do not meet the requirements of Section 422. As of June 30, 2005, options to purchase 639,697 shares of our common stock are outstanding under the 2003 Plan. No options or other equity-based awards have been granted under the 2003 Plan since the adoption of the 2005 Plan, and no further options or other equity-based awards are issuable under the 2003 Plan. As of June 30, 2005, no options granted under the 2003 Plan have been exercised.
1996 Stock Option Plan
      In 1996, we adopted our 1996 Stock Option Plan (1996 Plan). The 1996 Plan permitted the granting of awards to our officers, key employees, directors and collaborating scientists in the form of incentive or nonqualified stock options. Stock options granted under the 1996 Plan may be “incentive stock options” meeting the requirements of Section 422 of the Code or nonqualified stock options which do not meet the requirements of Section 422. Since the adoption of the 2003 Plan, we have not granted any stock options under the 1996 Plan. As of June 30, 2005, options to purchase 260,178 shares of our common stock are outstanding under the 1996 Plan. No further options or other equity-based awards are issuable under the 1996 Plan. As of June 30, 2005, no options granted under the 1996 Plan have been exercised.

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Employment Agreement
Employment Agreement with Joseph V. Gulfo, M.D.
      On January 5, 2004, we entered into an employment agreement with Dr. Joseph V. Gulfo, our President and Chief Executive Officer. Pursuant to the agreement, Dr. Gulfo is required to devote substantially all of his business time, attention and efforts to the performance of his duties under the agreement. The initial term of the employment agreement extends until December 31, 2005 and will automatically renew for successive twelve-month (12) terms unless either party sends a written notice of termination within 90 days of the expiration of the initial term or renewal term, as the case may be.
      The employment agreement provides Dr. Gulfo with an annual base salary of $175,000 subject to periodic review by our board of directors. Our board of directors has determined that Dr. Gulfo was entitled to a review and salary increase in an amount to be agreed by Dr. Gulfo and the Company as a result of the equity financing consummated in October 2004, but to date our board of directors has not conducted a review or granted a salary increase. Dr. Gulfo is also entitled to receive yearly bonuses at the discretion of our board of directors. The target for such bonuses is 50% of Dr. Gulfo’s then current base salary.
      In addition, Dr. Gulfo is entitled to be reimbursed for certain travel expenses up to $1,100 per month, $2,000 per month for lodging expenses and for certain communication expenses, including cellular phone service and broadband internet service.
      If Dr. Gulfo’s employment is terminated by us without cause or Dr. Gulfo resigns for good reason, then Dr. Gulfo would be entitled to receive severance pay equal to 15 months of his then current base salary and, if Dr. Gulfo is then covered by health insurance provided by us, the cost to Dr. Gulfo of COBRA coverage for 15 months. If we elect not to renew Dr. Gulfo’s employment agreement, Dr. Gulfo is entitled to an amount equal to his then current base salary for nine months and, if Dr. Gulfo is covered by our health insurance policy at such time, the cost of COBRA for nine months (subject to reduction to the extent Dr. Gulfo received comparable benefits from a subsequent employer during such nine month period).
      Dr. Gulfo is subject to a non-compete covenant upon termination of his employment by us or him. The term of Dr. Gulfo’s non-compete covenant is one (1) year, which can be extended to two (2) years in the event we elect to pay him additional severance equal to twelve (12) months of his base salary at the time of termination and his most recent bonus (if any).
      The employment agreement provides for three separate grants of stock options. As of May 15, 2005, the first two stock option grants for the purchase of a total of 81,753 shares of our common stock at an exercise price of $0.46 per share have fully vested. The number of shares of our common stock subject to the third stock option can only be calculated at the time of PMA approval of MelaFind®. The number of shares purchasable under this option at an exercise price of $0.46 per share is equal to that number of shares of our common stock equal to four percent of our fully-diluted capital stock at the time of PMA approval of MelaFind® minus the number of shares of common stock underlying options granted to Dr. Gulfo under the employment agreement, which is 81,753. Assuming that 9,513,164 shares are outstanding as of the completion of this offering and remain the total number of shares outstanding on the date we receive PMA approval of MelaFind®(assuming in both cases the exercise of all outstanding options and warrants and the conversion of all convertible securities), the number of shares subject to this option would be 345,699. This third stock option grant vests 50% at the time of PMA approval of MelaFind®, and the remaining 50% vests in four equal installments over the one year period following such PMA approval of MelaFind®.
Consulting Agreements
Consulting Agreement with Breaux Castleman
      In June 2003, we entered into a consulting agreement with Breaux Castleman for consulting services related to FDA approval of MelaFind®, administrative matters, financial reporting, and our business and

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financial strategy. Under this agreement, Mr. Castleman receives compensation for each month of services rendered. During 2003 Mr. Castleman was paid at the rate of $8,000 for each month of services rendered and thereafter from 2004 onward he has been paid at the rate of $2,000 for each month of services rendered. We made payments pursuant to this consulting agreement of $48,000 in 2003, $22,000 in 2004, and $12,000 in 2005. These payments did not exceed $60,000 in any twelve-month period since June 2003. In connection with our consulting agreement with Mr. Castleman, we granted Mr. Castleman a restricted stock award of 75,000 shares of our common stock under our 2003 Plan for an aggregate purchase price of $34,500. Mr. Castleman issued an interest-bearing promissory note in the principal amount of $34,500 as payment for these shares. During the second quarter of 2005, this note was repaid in full. Our consulting agreement with Mr. Castleman is terminable by either party on 30 days’ written notice.
Consulting Agreement with Marek Elbaum, Ph.D.
      Pursuant to a consulting agreement effective as of May 31, 2005, we retained Marek Elbaum, Ph.D., our founder and former Chief Science and Technology Officer, as our Chief Scientist to provide services relating to the integration of our product development, mentoring and advising our staff scientists, providing new product vision, supporting of our research and development and providing such other services as assigned to him by our Chief Executive Officer. Pursuant to the consulting agreement, Dr. Elbaum will provide us with a majority of his business time in consideration of a monthly fee of approximately $14,500. The term of such agreement extends for a period of two years and is automatically renewable for an additional one year period unless either Dr. Elbaum or we decide to not so renew. In the event of a non-renewal, and in the event that Dr. Elbaum’s services terminate as a result of his death or disability, we will pay to Dr. Elbaum a termination fee of $100,000. In addition, upon termination of the consulting agreement for any reason other than a termination by us for cause, we will pay to Dr. Elbaum for 18 months an amount equal to what Dr. Elbaum would have had to pay to extend his insurance coverage under COBRA. Dr. Elbaum is subject to a non-compete covenant during the term of the consulting agreement and for a period of two years after the term of the consulting agreement. We have also agreed that all stock options previously granted to Dr. Elbaum will continue to vest in accordance with their original terms.
Consulting Agreement with Robert Friedman, M.D.
      Pursuant to a consulting agreement effective as of June 1, 2005, we have retained the services of Robert Friedman, M.D. for an initial term of one year as a consultant, medical advisor to our board of directors, and as a liaison between our board of directors and our Scientific and Medical Advisory Committee, and in connection with the clinical testing of MelaFind®. In consideration of rendering of these services, Dr. Friedman will be paid at a rate of $5,000 per day (assuming an eight-hour day) for up to 30 days of service. The consulting agreement is automatically renewed for successive one-year terms unless either party terminates the agreement at least 30 days prior to the expiration of the agreement.
Consulting Agreement with Gerald Wagner, Ph.D.
      Pursuant to a consulting agreement dated as of June 1, 2005 with Gerald Wagner Consulting LLC (GWC), a company owned and operated by Dr. Gerald Wagner, GWC has agreed to direct our MelaFind® product development efforts and oversee the manufacturing process for a period that began June 1, 2005 and ends three months following the initiation of our pivotal clinical trial of MelaFind®. The consulting agreement provides for a flat fee of $150,000, payable ratably over the course of the term, and the grant to Dr. Wagner immediately after completion of this offering of a non-qualified stock option to purchase up to 50,000 shares of our common stock at the public offering price per share.
Limitation of Liability and Indemnification of Directors and Officers
      Our fourth amended and restated certificate of incorporation and third amended and restated bylaws provide that we will indemnify our directors and executive officers and may indemnify our other officers and employees and other agents to the fullest extent permitted by law. Our fourth amended and restated

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certificate of incorporation and third amended and restated bylaws also permit us to secure insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in such capacity, regardless of whether the bylaws would permit indemnification. We maintain directors’ and officers’ liability insurance. We believe that these provisions and agreements are necessary to attract and retain qualified persons as directors and executive officers.
RELATED PARTY TRANSACTIONS
      We also describe below certain other transactions with our directors, executive officers and stockholders.
     Common Stock
      In June 2003, we sold 75,000 shares of our common stock at a price of $0.46 per share to Dr. Robert Friedman, a former member of our board of directors, and 75,000 shares of our common stock at a price of $0.46 per share to Breaux Castleman, a member of our board of directors, and the chairman of our board. In May 2004, we issued 125,000 shares of our common stock at a per share purchase price of $0.46 to investors who loaned an aggregate of $1,000,000 to the Company, which loans were evidenced by convertible promissory notes, all of which converted into shares of our Series C preferred stock on October 26, 2004.
     Preferred Stock
      All share numbers and share prices presented below for our preferred stock and Series C preferred stock warrants do not reflect the 1-for-2 reverse stock split approved by our board of directors on May 13, 2005 with respect to our common stock. The reverse split will be effective after the conversion of our preferred stock and thus the shares of our common stock into which our preferred stock will convert will be subject to the reverse stock split.
      In 1998, we issued 198,000 shares of our Series A preferred stock at a per share purchase price of $5.00 to 22 accredited investors for an aggregate consideration of $990,000. All shares of Series A preferred stock will convert into an aggregate of 115,201 shares of our common stock upon completion of this offering.
      In 2000 and 2001, we issued an aggregate of 947,986 shares of our Series B preferred stock in three transactions at per share purchase prices of $5.1282 and $6.50 to 149 accredited investors for an aggregate consideration of $5,894,409. The rights of the holders of Series B preferred stock were identical except for the purchase prices paid for such stock. The purchasers of our Series B preferred stock included Arcadian Venture Partners L.P., a venture fund with which George C. Chryssis, a member of our board of directors, is affiliated, and Double D Venture Fund, LLC, a venture fund with which Sidney Braginsky, a member of our board of directors, is affiliated.
      On June 20, 2003, we issued an aggregate of 45,000 shares of our Series B preferred stock to the original Series B preferred stock investors in consideration of certain amendments to their investment agreements, bringing the total number of shares of our Series B preferred stock outstanding to 992,986. All shares of our Series B preferred stock will convert into an aggregate of 575,532 shares of our common stock upon completion of this offering.
      From June 2003 to October 2004, we sold an aggregate of 5,414,779 shares of our Series C preferred stock (together with warrants to purchase an aggregate of 2,610,643 shares of our common stock, all of which warrants will be converted into an aggregate of 1,305,321 shares of our common stock pursuant to the warrant exchange described below under “Warrants to Purchase Common Stock”) to 73 accredited investors for an aggregate consideration of $12,191,480. These investors included: Breaux Castleman, a member of our board of directors and chairman of our board; Dr. Robert Friedman, a member of our scientific and medical advisory committee and former member of our board of directors; Double D Venture Fund, LLC, a venture fund with which Sidney Braginsky, a member of our board of directors, is affiliated; and Dan W. Lufkin, a member of our board of directors. All shares of our Series C preferred

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stock will convert into an aggregate of 2,707,372 shares of our common stock upon completion of this offering.
     Warrants to Purchase Preferred Stock
      In June 2003, we issued a warrant to purchase up to 24,890 shares of our Series C preferred stock at an exercise price of $2.26 per share to Koji Miyazaki, one of our Series C preferred stock investors.
      In February 2004, we issued a warrant to purchase up to 121,681 shares of our Series C preferred stock with an exercise price of $2.26 per share to Health Partners I, LLC (HP I). In November 2004, HP I was dissolved and this warrant, together with all shares of our Series C preferred stock and warrants to purchase our common stock previously issued to HP I, were distributed to HP I’s members, which included: Dr. Robert Friedman, a member of our scientific and medical advisory committee and a former member of our board of directors; Breaux Castleman, a member of our board of directors and chairman of our board; and Dan W. Lufkin, a member of our board of directors. Assuming conversion of our preferred stock immediately prior to completion of this offering, these warrants and the warrant issued to Mr. Miyazaki will be exercisable for an aggregate of 73,280 shares of our common stock at an exercise price of $4.52 per share.
     Warrants to Purchase Common Stock
      Prior to the closing of this offering, we will consummate an exchange of warrants to purchase our common stock for shares of our common stock under a plan of recapitalization to be adopted by our board of directors. During the period from June 2003 through October 2004, we issued warrants to purchase an aggregate of up to 2,610,643 shares of our common stock to certain holders of our Series C preferred stock. All of these warrants have an exercise price of $13.00 per share. In June 2003, we also issued a warrant to Dr. Marek Elbaum, our former Chief Science and Technology Officer, to purchase up to 25,000 shares of our common stock at per share exercise price of $13.00. In December 2004, we issued a warrant to Allen & Company LLC to purchase up to 75,000 shares of our common stock at an exercise price of $7.00 per share (Allen & Company Warrant) in consideration of Allen & Company’s agreement to provide certain advisory services to us. Warrants to purchase a total of 2,610,643 shares of our common stock will be exchanged for a total of 1,305,321 shares of our common stock based on an exchange ratio of one share of our common stock for every two shares of our common stock purchasable under the warrants (Warrant Exchange).
      After completion of the Warrant Exchange, the only warrants that will remain outstanding as of the date of this offering are the Allen & Company Warrant, the underwriters’ warrant (see “Underwriting”) and warrants to purchase an aggregate of 146,571 shares of our Series C preferred stock, which assuming conversion of such Series C preferred stock will be exercisable for an aggregate of 73,280 shares of our common stock.
     Options
      From inception to June 30, 2005, we have granted an aggregate of 525,989 options to our current directors and named executive officers, with exercise prices ranging from $0.46 to $10.00 per share.
     Voting Agreement
      We entered into a voting agreement with certain holders of our common stock and preferred stock, which fixes the size of our board of directors at nine and entitles the holders of a majority of our common stock to designate two directors, the holders of a majority of our Series B preferred stock to designate one director and the holders of a majority of our Series C preferred stock to designate four directors. Currently, Joseph V. Gulfo, M.D. is the sole designee of the holders of our common stock, George C. Chryssis is the designee of the holders of our Series B preferred stock, and Breaux Castleman and Dan W. Lufkin are the sole designees of the holders of our Series C preferred stock. Upon the closing of this offering, the voting agreement will be terminated and none of our stockholders will have any special rights regarding board representation.

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PRINCIPAL STOCKHOLDERS
      The following tables set forth as of June 30, 2005, and as adjusted to reflect the sale of the shares offered hereby, certain information regarding beneficial ownership of our common stock by:
  •  each person or group of affiliated persons known to us to beneficially own more than 5% of our common stock;
 
  •  each named executive officer;
 
  •  each of our directors; and
 
  •  all of our executive officers and directors as a group.
      The percentage of ownership indicated in the following table is based on 6,513,164 shares of common stock outstanding on June 30, 2005 and 9,513,164 shares of common stock outstanding immediately following the completion of this offering, each of which assumes the conversion of all outstanding shares of our preferred stock and consummation of the Warrant Exchange. The table assumes no exercise of the underwriters’ over-allotment option.
      Information with respect to beneficial ownership has been furnished by each director, officer, beneficial owner of more than 5% of our common stock or selling stockholder and is determined in accordance with the rules of the SEC. Except as indicated by footnote and subject to community property laws where applicable, to our knowledge, the persons named in the table below have sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them. In computing the number of shares beneficially owned by a person and the percentage of ownership of that person, shares of common stock subject to options or warrants held by that person that are currently exercisable or will become exercisable within 60 days after June 30, 2005 are deemed outstanding, while such shares are not deemed outstanding for purposes of computing percentage ownership of any other person.
                                   
    Number of        
    Shares of Common    
    Stock Beneficially   Percentage of Shares
    Owned   Beneficially Owned
         
        Options and    
        Warrants    
        Exercisable    
        Within 60   Before the   After the
Name of Beneficial Owner   Shares   Days   Offering   Offering
                 
Named Executive Officers
                               
Joseph V. Gulfo, M.D. 
          81,753       1.2 %     *  
Marek Elbaum, Ph.D.(1)
    462,500       14,070       7.3       5.0 %
Karen Krumeich
          60,000       *       *  
William R. Bronner
    4,850       70,285       1.1       *  
Jon I. Klippel
          45,000       *       *  
 
Directors
                               
Breaux Castleman
    91,570       6,168       1.5       1.0  
Sidney Braginsky(2)
    51,500       5,000       *       *  
George C. Chryssis(3)
    94,717       12,500       1.6       1.1  
Dan W. Lufkin(4)
    356,231       29,187       5.9       4.0  
Gerald Wagner, Ph.D. 
                       
All directors and named executive
                               
 
officers as a group (all 10 persons)
    1,061,368       323,963       20.3 %     14.1 %
 
Holders of more than 5%
                               
Patricia and Stanley Brilliant(5)
    349,532       2,342       5.4       3.7  
S. Donald Sussman(6)
    917,767       11,693       14.2       9.8  
Eric Dobkin(7)
    351,523       7,015       5.5       3.8  

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  *   Less than one percent.
(1)  Marek Elbaum, Ph.D. resigned as a director and our Chief Science and Technology Officer effective as of May 31, 2005.
 
(2)  Includes 51,500 shares of common stock held by Double D Venture Fund, LLC, an investment fund with which Mr. Braginsky is affiliated. Mr. Braginsky expressly disclaims ownership of these shares except to the extent of his pecuniary interest in Double D Venture Fund, LLC
 
(3)  Includes 94,717 shares of common stock held by Arcadian Venture Partners, L.P., an investment fund with which Mr. Chryssis is affiliated. Mr. Chryssis expressly disclaims ownership of these shares except to the extent of his pecuniary interest in Arcadian Venture Partners, L.P.
 
(4)  Includes 140,570 shares of common stock held by trusts the beneficiaries of which are family members of Mr. Lufkin and 5,840 shares of common stock issuable upon exercise of Series C preferred stock warrants. Mr. Lufkin expressly disclaims ownership of the shares held by these trusts.
 
(5)  Patricia and Stanley Brilliant are husband and wife. Their business address is: 180 East End Avenue, Apt. 4A, New York, NY 10128.
 
(6)  The business address of S. Donald Sussman is: 2 American Lane, Greenwich, CT 06836.
 
(7)  The business address of Eric Dobkin is: 160 Old Church Lane, Pound Ridge, NY 10576.

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DESCRIPTION OF CAPITAL STOCK
      The following information describes our common stock and preferred stock and provisions of our fourth amended and restated certificate of incorporation and our third amended and restated bylaws as in effect upon the closing of this offering. This description is only a summary. You should also refer to the fourth restated certificate of incorporation and third amended and restated bylaws which will be filed with the SEC as exhibits to our registration statement of which this prospectus forms a part. The descriptions of the common stock and preferred stock reflect changes to our capital structure that will occur upon the receipt of the requisite board and stockholder approvals and upon the closing of this offering in accordance with the terms of the fourth amended and restated certificate of incorporation.
      Upon completion of this offering, and after giving effect to the conversion of all outstanding convertible preferred stock into common stock and the amendment of our fourth amended and restated certificate of incorporation, our authorized capital stock will consist of 30,000,000 shares of common stock, $0.001 par value per share, and 10,000,000 shares of preferred stock, $0.10 par value per share. As of June 30, 2005, there were 6,513,164 shares of our common stock outstanding held of record by 242 stockholders.
Common Stock
      Subject to preferences that may be applicable to any shares of preferred stock outstanding at the time, the holders of common stock are entitled to the following:
      Dividends. The holders of outstanding shares of our common stock are entitled to receive dividends out of assets legally available for the payment of dividends at the times and in the amounts as our board of directors from time to time may determine, subject to any preferential dividend rights of any holder of outstanding shares of our preferred stock.
      Voting. Each holder of common stock is entitled to one vote for each share of common stock held on all matters submitted to a vote of stockholders, including the election of directors. We have not provided for cumulative voting for the election of directors in our fourth restated certificate of incorporation. This means that the holders of a majority of the shares voted can elect all of the directors then standing for election.
      Preemptive rights, conversion and redemption. Our common stock is not entitled to preemptive rights and is not subject to conversion or redemption.
      Liquidation, dissolution and winding-up. Upon our liquidation, dissolution or winding-up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities and the liquidation preferences of any preferred stock.
      Each outstanding share of common stock is, and all shares of common stock to be issued in this offering when they are paid for, will be duly and validly issued, fully paid and non-assessable.
Options
      As of June 30, 2005, options to purchase a total of 899,875 shares of common stock were outstanding. All options issued under the 2003 Plan or issuable under the 2005 Plan are subject to 180-day lock-up provisions under the terms of the 2003 Plan and the 2005 Plan, respectively. Options to purchase a total of 1,000,000 shares of common stock remain available for grant under the 2005 Plan. Following this offering, no options to purchase, or other equity-based awards with respect to shares of our common stock, will be available under the 2003 Plan or the 1996 Plan.
Preferred Stock
      Upon the closing of this offering, all outstanding shares of our preferred stock will convert into an aggregate of 3,398,105 shares of common stock.
      Following the offering, our board of directors will be authorized, subject to the limits imposed by the Delaware General Corporation Law, to issue 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any of its qualifications,

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limitations and restrictions. Our board of directors can also increase or decrease the number of shares of any series, but not below the number of shares of that series then outstanding, without any further vote or action by our stockholders.
      Our board of directors may authorize the issuance of preferred stock with voting or conversion rights that adversely affect the voting power or other rights of our common stockholders. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions, financings and other corporate purposes, could have the effect of delaying, deferring or preventing a change in control and may cause the market price of our common stock to decline or impair the voting and other rights of the holders of our common stock. We have no current plans to issue shares of preferred stock.
Warrants
      See “Related Party Transactions — Warrants to Purchase Preferred Stock” and “Related Party Transactions — Warrants to Purchase Common Stock.”
Registration Rights
      Under a second amended and restated investors’ rights agreement, following this offering, the holders of 5,090,001 shares of common stock (including shares of our common stock purchasable pursuant to warrants to purchase our common stock) have the right to require us to register their shares with the SEC so that those shares may be publicly resold or to include their shares in any registration statement we file with the SEC.
     Demand Rights
      At any time after the earlier of October 26, 2009 or the date which is one year after the effective date of this offering, if the holders of more than 20% of the outstanding shares of common stock issued or issuable upon conversion of our existing Series B preferred stock or Series C preferred stock or upon exercise of warrants to purchase our common stock held by holders of our existing Series B preferred stock or Series C preferred stock, request that we file a registration statement with the SEC having an aggregate offering price to the public (after deduction of underwriter’s discounts and expenses) of not less than $2,000,000, we are obligated to use our commercially reasonable efforts to cause such shares to be registered and to include in such registration, if requested, additional shares of our common stock requested to be included by holders of registration rights who deliver a written notice to us within 20 days of our receipt of notice from the initiating holders. We are only required to effect two such registrations, and we are not required to effect any such registration during period commencing 90 days before a company initiated registration and ending 90 days after a company initiated registration. Our board of directors has the right to defer for not more than 90 days and not more than twice in any 12-month period any such registration if in its good faith judgment such registration would be detrimental to us and not in our best interest.
      If we are eligible to file a registration statement on Form S-3, holders of shares having registration rights have the right to demand on or prior to the fifth anniversary of the effective date of this offering that we file a registration statement on Form S-3. We are only required to effect two such registrations in any 12-month period, and we are not required to effect any such registration during period commencing 90 days before a company-initiated registration and ending 90 days after a company-initiated registration.
     Piggy Back Registration Rights
      The holders of shares having registration rights are entitled to unlimited “piggy-back” registration rights on all registrations of our stock other than a registration relating solely to employee benefit plans, a registration on Form S-4 or any other form that does not permit secondary sales or a registration pursuant to the demand rights described above. Pursuant to the lock-up agreements we expect to enter into with our directors, officers and certain stockholders, any such person holding “piggy-back” registration rights will waive such rights with respect to this offering.

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     Limitations on Registration Rights
      We and the underwriters of any underwritten offering will have the right to limit the number of shares having registration rights to be included in the registration statement. The underwriters have excluded any sales by existing investors in this offering.
     Expenses of Registration
      We shall bear all registration expenses, exclusive of underwriting discounts, selling commissions, stock transfer taxes and fees and disbursements of counsel for the holders of registration rights (other than customary fees of one counsel in the case of a demand registration), of all demand and piggy-back registrations.
Delaware Anti-Takeover Law
      We are subject to the provisions of Section 203 of the Delaware General Corporation Law, or Delaware law, regulating corporate takeovers. In general, these provisions prohibit a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the date that the stockholder became an interested stockholder, unless:
  •  the transaction is approved by the board of directors before the date the interested stockholder attained that status;
 
  •  upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced; or
 
  •  on or after the date the business combination is approved by the board of directors and authorized at a meeting of stockholders, by at least two-thirds of the outstanding voting stock that is not owned by the interested stockholder.
Section 203 defines “business combination” to include the following:
  •  any merger or consolidation involving the corporation and the interested stockholder;
 
  •  any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder;
 
  •  subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
 
  •  any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or
 
  •  the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.
      In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling or controlled by any of these entities or persons.
      A Delaware corporation may opt out of this provision either with an express provision in its original certificate of incorporation or in an amendment to its certificate of incorporation or bylaws approved by its stockholders. However, we have not opted out of this provision. The statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts to acquire us.

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Provisions of our Certificate of Incorporation and Bylaws and Certain Regulatory Requirements That May Have an Anti-Takeover Effect or Entrench Current Management
      Our fourth amended and restated certificate of incorporation and third amended and restated bylaws will contain certain provisions that are intended to enhance the likelihood of continuity and stability in the composition of our board of directors and the policies formulated by our board of directors. These provisions are also expected to discourage certain types of coercive takeover practices and inadequate takeover bids and to encourage persons seeking to acquire control of us to first negotiate with us. These provisions, as well as certain provisions of contracts to which we are a party, may discourage or hinder attempts to acquire us or remove incumbent directors or management even if some, or a majority, of our stockholders believe that such action is in their best interest.
           Certificate of Incorporation and Bylaws.
      The provisions in our fourth amended and restated certificate of incorporation and third amended and restated bylaws with the intent described above include:
  •  Vacancies Filled by the Board. Vacancies on our board of directors may be filled by a majority of the remaining directors (even if they constitute less than a quorum), or by a sole remaining director.
 
  •  Removal of Directors. None of our directors may be removed other than for cause.
 
  •  Stockholder Meetings. Only our board of directors, the chairman of our board of directors or our chief executive officer may call special meetings of stockholders. Stockholders cannot call special meetings of stockholders.
 
  •  No Action by Written Consent. Stockholders may take action only at an annual or special meeting of stockholders. Stockholders may not act by written consent.
 
  •  Requirements for Advance Notification of Stockholder Proposals and Director Nominations. Stockholders must comply with advance notice procedures with respect to stockholder proposals and the nomination of candidates for election as directors. In general, these provisions will provide that notice of intent to nominate a director or raise matters at such meetings must be received in writing by us not less than 90 nor more than 120 days prior to the anniversary of the date of the proxy statement for the previous year’s annual meeting of stockholders, and must contain certain information concerning the person to be nominated or the matters to be brought before the meeting and concerning the stockholder submitting the proposal.
 
  •  No Cumulative Voting. There is no cumulative voting in the election of directors.
 
  •  “Blank Check” Preferred Stock. We will be authorized to issue, without any further vote or action by the stockholders, up to 10,000,000 shares of preferred stock in one or more classes or series and, with respect to each such class or series, to fix the number of shares constituting the class or series and the designation of the class or series, the voting powers (if any) of the shares of the class or series, and the preferences and relative, participating, optional and other special rights, if any, and any qualifications, limitations or restrictions, of the shares of such class or series.
 
  •  Regulatory Approval. We are also required to obtain the approval of certain regulatory agencies, such as the NASD, for certain transactions that could result in a change of control. See “Our Business — Regulation.”
Transfer Agent and Register
      The transfer agent and registrar for the common stock is the American Stock Transfer and Trust Company.

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Listing
      We have applied to have our common stock approved for listing, subject to official notice of issuance, on the NASDAQ National Market under the symbol “MELA.” We have not applied to list our common stock on any other exchange or quotation system.
SHARES ELIGIBLE FOR FUTURE SALE
      Prior to this offering, there has been no market for our common stock, and a liquid trading market for our common stock may not develop or be sustained after this offering. Future sales of substantial amounts of our common stock, including shares issued upon exercise of outstanding options and warrants or in the public market after this offering, or the anticipation of those sales, could adversely affect the price of our common stock from time to time and could impair our ability to raise capital through sales of our equity securities. Upon completion of this offering, we will have outstanding an aggregate of 9,513,164 shares of common stock, after giving effect to the issuance of 3,000,000 shares of common stock in this offering and the conversion of all outstanding shares of our convertible preferred stock into an aggregate of 3,398,105 shares of our common stock.
Sales of Restricted Shares
      Of the shares to be outstanding after the completion of this offering, the 3,000,000 shares sold in this offering will be freely tradable without restriction under the Securities Act of 1933, as amended (Securities Act) unless purchased by our “affiliates,” as that term is defined in Rule 144 under the Securities Act. Of the remaining 6,513,164 shares of common stock, 598,868 are held by “affiliates.” The shares of common stock held by affiliates and all other shares of common stock other than those sold in this offering are “restricted securities” within the meaning of Rule 144. All of the shares of common stock held by affiliates will be subject to the 270-day lock-up period described below. After the 270-day lock-up period, these restricted securities may be sold in the public market only if registered or if they qualify for an exemption from registration under Rules 144, 144(k) or 701 promulgated under the Securities Act, which are summarized below. Sales of the restricted securities in the public market, or the availability of such shares for sale, could adversely affect the market price of our common stock.
      Our directors, officers and certain significant stockholders intend to enter into lock-up agreements in connection with the offering generally providing that they will not offer, sell, contract to sell or grant any option to purchase or otherwise dispose of our common stock or any securities exercisable for or convertible into our common stock owned by them for a period of 270 days after the date of this prospectus without the prior written consent of the underwriters, which consent may be withheld in their sole discretion. Such shareholders may make gifts of our common stock within the restricted period provided the recipient agrees in advance to be bound by the lock-up restrictions. Taking into account the lock-up agreements, and assuming the underwriters do not release any stockholders from these agreements, we estimate that the number of restricted shares that will be available for sale in the public market under the provisions of Rule 144 and 144(k) will be approximately as follows:
  •  beginning on the effective date of this prospectus, in addition to the shares sold in the offering, approximately 1,306,000 shares of our restricted shares will be eligible for sale subject to the volume, manner of sale and other limitations under Rule 144;
 
  •  beginning 270 days after the effective date, approximately 6,386,000 shares of our restricted shares will be eligible for sale subject to the volume, manner of sale and other limitations under Rule 144; and
 
  •  beginning 270 days after the effective date, approximately 3,026,000 shares of our restricted shares will be eligible for sale as unrestricted shares under Rule 144(k).

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      In general, under Rule 144 as currently in effect, after the expiration of the lock-up agreements, a person who has beneficially owned restricted securities for at least one year would be entitled to sell within any three-month period a number of shares that does not exceed the greater of:
  •  one percent of the number of shares of common stock then outstanding, which will equal approximately 95,136 shares immediately after the offering; or
 
  •  the average weekly trading volume of our common stock during the four calendar weeks preceding the filing of a notice on Form 144 with respect to that sale.
      Sales under Rule 144 are also subject to requirements with respect to manner of sale, notice and the availability of current public information about us. Under Rule 144(k), generally, a person who is not deemed to have been our affiliate at any time during the three months preceding a sale and who has beneficially owned the shares proposed to be sold for at least two years, is entitled to sell such shares without complying with the manner of sale, public information, volume limitation or notice provisions of Rule 144.
Rule 701
      In general, under Rule 701 of the Securities Act as currently in effect, any of our employees, directors or consultants who purchased shares of our common stock from us in connection with our stock option plans before the effective date of the registration statement of which this prospectus is a part, or who hold stock options as of that date, may rely on the resale provisions of Rule 701. Under Rule 701, these persons who are not our affiliates may generally sell their eligible securities, commencing 90 days after the effective date of the registration statement in reliance on Rule 144, but without compliance with some of the restrictions, including the holding period and volume limitations contained in Rule 144. Rule 152 under the Securities Act provides a safe harbor for transactions not involving any public offering even if the issuer subsequently files a registration statement. Also, Rule 701 states that offers and sales exempt under Rule 701 are deemed to be part of a single, discrete offering and are not subject to integration with other offers or sales (whether registered or not). We therefore believe that the issuance of common stock upon the exercise of options by our employees, directors or consultants should not be integrated with the issuance of common stock in this offering.
      Subject to the 270-day lock-up period described above, as of the date 90 days after the effective date of this offering, holders of vested options exercisable for approximately 573,550 shares of our common stock will be eligible to exercise their options and to sell their shares in accordance with Rule 701.
Stock Options
      We intend to file a registration statement under the Securities Act covering the shares of common stock reserved for issuance upon exercise of outstanding options under our 2005 Plan, our 2003 Plan and our 1996 Plan. The registration statement is expected to be filed 270 days after the closing of this offering and become effective as soon as practicable after filing. Accordingly, shares registered under the registration statement will be available for sale in the open market after the effective date of the registration statement subject to manner of sale, public information, volume limitation and notice provisions of Rule 144 applicable to our affiliates, and any limitations on sale under the applicable option plan and the lock-up agreements described above. See “Risk Factors — If there are substantial sales of our common stock, our stock price could decline.”

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MATERIAL US FEDERAL INCOME AND
ESTATE TAX CONSIDERATIONS FOR NON-US HOLDERS
      The following is a general discussion of the material US federal income and estate tax consequences of the ownership and disposition of our common stock by a non-US holder that purchases shares pursuant to this offer. As used in this discussion, the term non-US holder means a beneficial owner of our common stock that is not, for US federal income tax purposes:
  •  an individual who is a citizen or resident of the US;
 
  •  a corporation or partnership (including any entity treated as a corporation or partnership for US federal income tax purposes) created or organized in or under the laws of the US or any State thereof or the District of Columbia, other than a partnership treated as foreign under US Treasury regulations;
 
  •  an estate whose income is includible in gross income for US federal income tax purposes regardless of its source; or
 
  •  a trust (1) if a US court is able to exercise primary supervision over the administration of the trust and one or more US persons have authority to control all substantial decisions of the trust, or (2) that has a valid election in effect under applicable Treasury regulations to be treated as a US person.
      This discussion does not consider:
  •  US federal gift tax consequences, US state or local or non-US tax consequences;
 
  •  specific facts and circumstances that may be relevant to a particular non-US holder’s tax position, including, if the non-US holder is a partnership or trust that the US tax consequences of holding and disposing of our common stock may be affected by certain determinations made at the partner or beneficiary level;
 
  •  the tax consequences for the stockholders, partners or beneficiaries of a non-US holder;
 
  •  special tax rules that may apply to particular non-US holders, such as financial institutions, insurance companies, tax-exempt organizations, hybrid entities, US expatriates, broker-dealers, and traders in securities; or
 
  •  special tax rules that may apply to a non-US holder that holds our common stock as part of a straddle, hedge, conversion transaction, synthetic security or other integrated investment.
      The following discussion is based on provisions of the Code, applicable US Treasury regulations and administrative and judicial interpretations, all as in effect on the date of this prospectus, and all of which are subject to change, retroactively or prospectively. The following summary assumes that a non-US holder holds our common stock as a “capital asset” within the meaning of section 1221 of the Code (generally, property held for investment). Each non-US holder should consult a tax advisor regarding the US federal, state, local and non-US income and other tax consequences of acquiring, holding and disposing of shares of our common stock.
Dividends
      We do not plan to pay any dividends on our common stock for the foreseeable future. However, in the event that we pay dividends on our common stock, we will have to withhold a US federal withholding tax at a rate of 30%, or a lower rate under an applicable income tax treaty, from the gross amount of dividends paid to a non-US holder.
      Dividends that are effectively connected with a non-US holder’s conduct of a trade or business in the US or, if an income tax treaty applies, attributable to a permanent establishment in the US (effectively connected income or ECI), are taxed on a net income basis at the regular graduated rates and in the manner applicable to US persons. In that case, we will not have to withhold US federal withholding tax if

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the non-US holder complies with applicable certification and disclosure requirements. In addition to the US tax on ECI, in the case of a holder that is a foreign corporation and has ECI, a branch profits tax may be imposed at a 30% rate, or a lower rate under an applicable income tax treaty, on the dividend equivalent amount.
      In order to claim the benefit of an income tax treaty or claim exemption from withholding because the income is effectively connected with the conduct of a trade or business in the US, the non-US holder must provide a properly executed Form W-8BEN, for treaty benefits, or W-8ECI, for effectively connected income, prior to the payment of dividends. These forms must be periodically updated. Non-US holders should consult their tax advisors regarding their entitlement to benefits under a relevant income tax treaty and their ability to claim exemption from withholding because the income is effectively connected with the conduct of a trade or business in the US, and related certification requirements.
      A non-US holder that is eligible for a reduced rate of US federal withholding tax under an income tax treaty may obtain a refund or credit of any excess amounts withheld by filing an appropriate claim for a refund with the US Internal Revenue Service (IRS) in a timely manner.
Gain on Disposition of Common Stock
      A non-US holder generally will not be taxed on gain recognized on a disposition of our common stock unless:
  •  the gain is effectively connected with a non-US holder’s conduct of a trade or business in the US or, alternatively, if an income tax treaty applies, is attributable to a permanent establishment maintained by the non-US holder in the US; in these cases, the gain will be taxed on a net income basis at the regular graduated rates and in the manner applicable to US persons, unless an applicable treaty provides otherwise, and, if the non-US holder is a foreign corporation, the branch profits tax described above may also apply;
 
  •  the non-US holder is an individual who holds our common stock as a capital asset, is present in the US for 183 days or more in the taxable year of the disposition and meets other requirements; in this case, the non-US holder will be subject to a 30% tax on the gain derived from the disposition; or
 
  •  we are or have been a US real property holding corporation (USRPHC) for US federal income tax purposes at any time during the shorter of the five-year period ending on the date of disposition or the period that the non-US holder held our common stock; in this case, the non-US holder may be subject to US federal income tax on its net gain derived from the disposition of our common stock at regular graduated rates. Generally, a corporation is a USRPHC if the fair market value of its US real property interests equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests plus its other assets used or held for use in a trade or business. If we are, or were to become, a USRPHC, gain realized upon disposition of our common stock by a non-US holder that did not directly or indirectly own more than 5% of our common stock during the shorter of the five-year period ending on the date of disposition or the period that the non-US holder held our common stock generally would not be subject to US federal income tax, provided that our common stock is “regularly traded on an established securities market” within the meaning of Section 897(c)(3) of the Code. We believe that we are not currently, and we do not anticipate becoming in the future, a USRPHC.
Federal Estate Tax
      Common stock owned or treated as owned by an individual who is a non-US holder at the time of death, unless an applicable estate tax or other treaty provides otherwise, will be included in the individual’s gross estate for US federal estate tax purposes, and therefore may be subject to US federal estate tax.

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Information Reporting and Backup Withholding Tax
      We must report annually to the IRS and to each non-US holder the amount of dividends paid to that holder and the tax withheld from those dividends. These reporting requirements apply regardless of whether withholding was reduced or eliminated by an applicable income tax treaty. Copies of the information returns reporting those dividends and withholding may also be made available to the tax authorities in the country in which the non-US holder is a resident under the provisions of an applicable income tax treaty or agreement.
      Under some circumstances, US Treasury regulations require additional information reporting and backup withholding (currently at a rate of 28%) on some payments on our common stock. The gross amount of dividends paid to a non-US holder that fails to certify its non-US holder status in accordance with applicable US Treasury regulations generally will be reduced by backup withholding at the applicable rate.
      The payment of the proceeds of the disposition of our common stock by a non-US holder to or through the US office of any broker generally will be reported to the IRS and reduced by backup withholding unless the non-US holder either certifies its status as a non-US holder under penalties of perjury or otherwise establishes an exemption. The payment of the proceeds of the disposition of our common stock by a non-US holder to or through a non-US office of a non-US broker generally will not be reduced by backup withholding or reported to the IRS unless the non-US broker has certain enumerated connections with the US. In general, the payment of proceeds from the disposition of our common stock by or through a non-US office of a broker that is a US person or that has certain enumerated connections with the US will be reported to the IRS and may, in limited circumstances, be reduced by backup withholding, unless the broker receives a statement from the non-US holder, signed under penalty of perjury, certifying its non-US status or the broker has documentary evidence in its files that the holder is a non-US holder.
      Non-US holders should consult their own tax advisors regarding the application of the information reporting and backup withholding rules to them.
      Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules from a payment to a non-US holder will be refunded, or credited against the holder’s US federal income tax liability, if any, provided that the required information or appropriate claim for refund is furnished to the IRS in a timely manner.

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UNDERWRITING
      Under the terms and subject to the conditions in an underwriting agreement dated               , 2005, we have agreed to sell to the underwriters named below, for whom Ladenburg Thalmann & Co. Inc. and Stanford Group Company are acting as the representatives, the following respective numbers of shares of common stock:
         
Underwriters   Number of Shares
     
Ladenburg Thalmann & Co. Inc. 
       
Stanford Group Company
       
       
Total
    3,000,000  
       
      Subject to the terms and conditions of the underwriting agreement, the underwriters have agreed to purchase from us 3,000,000 shares of our common stock at the public offering price, less the underwriting discounts and commissions set forth on the cover page of this prospectus. The underwriting agreement provides that the underwriters’ obligations to purchase our shares are subject to approval of legal matters by counsel and to the satisfaction of other conditions. The underwriters are obligated to purchase all of the shares (other than those covered by the over-allotment option described below) if they purchase any shares. The underwriting agreement also provides that, if an underwriter defaults, the purchase commitments of non-defaulting underwriters may be increased or this offering may be terminated.
Commissions and Expenses
      The underwriters propose to offer the shares to the public at the public offering price set forth on the cover of this prospectus. The underwriters may offer the shares to securities dealers at the price to the public less a concession not in excess of $              per share. Securities dealers may reallow a concession not in excess of $              per share to other dealers. After the shares are released for sale to the public, the underwriters may vary the offering price and other selling terms from time to time. The underwriters will also receive a nonaccountable expense allowance equal to 1% of the public offering price set forth on the cover of this prospectus for the sale of all the shares sold (excluding shares sold pursuant to the overallotment option, if any).
      The following table shows the underwriting discounts and commissions that we are to pay to the underwriters in connection with this offering. These amounts are shown assuming no exercise and full exercise of the underwriters’ over-allotment option to purchase additional shares.
                 
    No Exercise   Full Exercise
         
Per Share
  $       $    
Total
  $       $    
      We estimate that the total expenses of this offering, excluding underwriting discounts and commissions, will be approximately $              .
Warrant
      We have agreed to sell to the representatives, for nominal consideration, a warrant (Underwriters’ Warrant) to purchase up to a total of 225,000 shares of our common stock. The Underwriters’ Warrant is not exercisable during the first year after the date of this prospectus and thereafter is exercisable at an exercise price equal to 125% of the public offering price per share set forth on the cover of this prospectus for a period commencing on the first anniversary of the date of this prospectus and ending on the fifth anniversary of the date of this prospectus. The Underwriters’ Warrant contains customary antidilution provisions and certain demand and participatory registration rights. The Underwriters’ Warrant also includes a “cashless” exercise provision entitling the holder to convert the Underwriters’ Warrant into shares of our common stock. The Underwriters’ Warrant may not be sold, transferred, assigned or hypothecated for a period of one year from the date of this prospectus, except to officers or partners of the underwriters and members of the selling group and/or their officers or partners.

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Over-Allotment Option
      We have granted to the underwriters an option, exercisable not later than 45 days after the date of this prospectus, to purchase up to an aggregate of 450,000 additional shares of common stock at the public offering price set forth on the cover page of this prospectus less the underwriting discounts and commissions. The underwriters may exercise this option in whole or in part only to cover over-allotments, if any, made in connection with the sale of shares offered hereby.
Lock-Up and Related Agreements
      Except as noted below, our directors, executive officers and principal stockholders will agree with the representatives that for a period of 270 days following the date of this prospectus, they will not offer, sell, assign, transfer, pledge, contract to sell or otherwise dispose of or hedge any of our shares of common stock or any securities convertible into or exchangeable for shares of common stock. Such shareholders may make gifts of our common stock within the restricted period provided the recipient agrees in advance to be bound by the lock-up restrictions. The representatives may, in their sole discretion, at any time without prior notice, release all or any portion of the shares from the restrictions in any such agreement. We have entered into an agreement with the representatives, stating that we will not issue additional shares (with the exception of shares issued pursuant to the over-allotment option) of our common stock prior to the end of the 270 day period following the date of this prospectus, other than with respect to our issuing shares pursuant to employee benefit plans, qualified option plans or other employee compensation plans already in existence, or pursuant to currently outstanding options, warrants or other rights to acquire shares of our common stock. There are no agreements between the representatives and any of our directors, executive officers or principal stockholder releasing them from these lock-up agreements, or with us pertaining to our issuance of additional shares, prior to the expiration of the 270 day period.
Indemnification
      We have agreed to indemnify the underwriters against certain civil liabilities, including liabilities under the Securities Act and liabilities arising from breaches of representations and warranties contained in the underwriting agreement, and to contribute to payments the underwriters may be required to make in respect of any such liabilities.
Stabilization, Short Positions and Penalty Bids
      The representatives may engage in over-allotment, stabilizing transactions, syndicate covering transactions, and penalty bids or purchases for the purpose of pegging, fixing or maintaining the price of the common stock, in accordance with Regulation M under the Securities Exchange Act of 1934:
  •  Over-allotment transactions involve sales by the underwriters of shares in excess of the number of shares the underwriters are obligated to purchase, which creates a syndicate short position. The short position may be either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they may purchase in the over-allotment option. In a naked short position, the number of shares involved is greater than the number of shares in the over-allotment option. The underwriters may close out any short position by either exercising their over-allotment option and/or purchasing shares in the open market.
 
  •  Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specific maximum.
 
  •  Syndicate covering transactions involve purchases of the common stock in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase shares through the over-allotment option. If the underwriters sell more shares

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  than could be covered by the over-allotment option, a naked short position, the position can only be closed out by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on the price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering.
 
  •  Penalty bids permit the representatives to reclaim a selling concession from a syndicate member when the common stock originally sold by the syndicate member is purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.
      These stabilizing transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of our common stock. As a result, the price of our common stock may be higher than the price that might otherwise exist in the open market. These transactions may be effected on the NASDAQ National Market or otherwise and, if commenced, may be discontinued at any time. Neither we nor any of the underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our common stock. In addition, neither we nor any of the underwriters make any representation that the representatives will engage in these stabilizing transactions or that any transaction, once commenced, will not be discontinued without notice.
Offering Price Determination
      Prior to this offering, there has been no market for our common stock. The public offering price has been, due to our lack of operating history, arbitrarily determined by negotiations between us and the representatives, bears no relationship to our earnings, book value, net worth or other financial criteria of value and may not be indicative of the market price for the common stock after this offering. After completion of this offering, the market price of the common stock will be subject to change as a result of market conditions and other factors.
Discretionary Accounts
      The representatives of the underwriters have advised us that they do not intend to confirm sales of the shares to discretionary accounts.
LEGAL MATTERS
      The validity of the common stock being offered hereby is being passed upon for us by Dreier LLP. We have received certain advice from our legal counsel in connection with the matters described herein. Certain legal matters relating to the offering will be passed upon for the underwriters by Greenberg Traurig, LLP, New York, New York. Prospective investors should consult with their own legal and other counsel.
EXPERTS
      The financial statements of Electro-Optical Sciences, Inc. as of December 31, 2003 and 2004, and for each of the three years in the period ended December 31, 2004, as set forth in their report, have been included herein and in the Registration Statement in reliance upon the report of Eisner LLP, independent registered public accounting firm, appearing elsewhere herein, and upon the authority of said firm as experts in accounting and auditing.

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WHERE YOU CAN FIND MORE INFORMATION
      We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of common stock we are offering to sell. This prospectus, which constitutes part of the registration statement, does not include all of the information contained in the registration statement. You should refer to the registration statement and its exhibits for additional information. Whenever we make reference in this prospectus to any of our contracts, agreements or other documents, the references are not necessarily complete and you should refer to the exhibits attached to the registration statement for copies of the actual contract, agreement or other document. When we complete this offering, we will also be required to file annual, quarterly and special reports, proxy statements and other information with the SEC. We anticipate making these documents publicly available, free of charge, on our website at www.eo-sciences.com as soon as reasonably practicable after filing such documents with the Securities and Exchange Commission.
      You can read the registration statement and our future filings with the SEC, over the internet at the SEC’s website at http://www.sec.gov. You may also read and copy any document that we file with the Securities and Exchange Commission at its public reference room at 450 Fifth Street, N.W., Washington, DC 20549.
      You may also obtain copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC at 450 Fifth Street, NW, Washington, DC 20549. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the public reference room.

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ELECTRO-OPTICAL SCIENCES, INC.
CONTENTS
           
Financial Statements:
       
Report of Independent Registered Public Accounting Firm
    F-2  
 
Balance sheets as of December 31, 2004 and 2003 and June 30, 2005 (unaudited)
    F-3  
 
Statements of operations for the years ended December 31, 2004, 2003 and 2002 and six months ended June 30, 2004 and 2005 (unaudited)
    F-4  
 
Statements of changes in stockholders’ (deficiency) equity for the years ended December 31, 2004, 2003 and 2002 and six months ended June 30, 2005 (unaudited)
    F-5  
 
Statements of cash flows for the years ended December 31, 2004, 2003 and 2002 and six months ended June 30, 2004 and 2005 (unaudited)
    F-6  
 
Notes to financial statements
    F-7  

F-1


 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Electro-Optical Sciences, Inc.
      The following report is in the form that will be signed upon the effectiveness of the one-for-two reverse common stock split described in Note 1 to the financial statements.
/s/ Eisner LLP
New York, New York
July 15, 2005
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
Electro-Optical Sciences, Inc.
      We have audited the accompanying balance sheets of Electro-Optical Sciences, Inc. (the “Company”) as of December 31, 2004 and 2003, and the related statements of operations, stockholders’ (deficiency) equity and cash flows for each of the years in the three year period ended December 31, 2004. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.
      We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
      In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Electro-Optical Sciences, Inc. as of December 31, 2004 and 2003, and the results of its operations and its cash flows for each of the years in the three year period ended December 31, 2004, in conformity with accounting principles generally accepted in the United States of America.
Eisner LLP
New York, New York
May 31, 2005

F-2


 

ELECTRO-OPTICAL SCIENCES, INC.
BALANCE SHEETS
                                     
    December    December        Pro-Forma
    31, 2003   31, 2004        
            June 30,   June 30,
            2005   2005
                 
    (audited)   (audited)   (unaudited)   (unaudited)
                (Note 1)
ASSETS
Current Assets:
                               
 
Cash and cash equivalents
  $ 116,691     $ 108,705     $ 176,208     $ 176,208  
 
Marketable securities
          6,594,751       3,617,713       3,617,713  
 
Accounts receivable, net
    16,679       7,128              
 
Inventories
    72,865       69,755              
 
Prepaid expenses and other current assets
    10,697       32,844       23,550       23,550  
 
Assets held for sale
                156,677       156,677  
 
Deferred registration costs
                752,042       752,042  
                         
   
Total Current Assets
    216,932       6,813,183       4,726,190       4,726,190  
Property and equipment, net
    18,418       89,306       154,510       154,510  
Patents and trademarks, net
    178,157       163,459       86,517       86,517  
Other assets
    18,248       30,201       30,201       30,201  
                         
   
Total Assets
  $ 431,755     $ 7,096,149     $ 4,997,418     $ 4,997,418  
                         
LIABILITIES AND STOCKHOLDERS’ (DEFICIENCY) EQUITY
Current Liabilities:
                               
 
Accounts payable (includes related parties of $2,000 as of December 31, 2004, and $79,645 as of June 30, 2005)
  $ 211,810     $ 338,821     $ 233,504     $ 233,504  
 
Accrued expenses
    363,270       228,583       339,283       339,283  
 
Accrued registration costs
                672,873       672,873  
 
Deferred revenues
          106,335              
 
Notes payable — stockholders and employees
    48,000                    
 
Notes payable — other
    15,000                    
 
Other current liabilities
    11,976       17,284              
                         
   
Total Current Liabilities
    650,056       691,023       1,245,660       1,245,660  
                         
REDEEMABLE CONVERTIBLE PREFERRED STOCK
                               
 
Redeemable preferred stock Series B convertible 992,986 shares designated (liquidation preference $2.26 per share); issued and outstanding 992,986 shares at December 31, 2003 and 2004 and June 30, 2005 and 0 shares at June 30, 2005, pro forma
    2,244,147       2,244,147       2,244,147        
                         
 
Redeemable preferred stock Series C convertible 5,744,340 shares designated (liquidation preference $2.26 per share); issued and outstanding 907,077 shares at December 31, 2003 and 5,414,779 shares at December 31, 2004 and June 30, 2005 and 0 shares at June 30, 2005, pro forma
    1,822,950       6,340,666       7,182,925        
                         
COMMITMENTS AND CONTINGENCIES
                               
Stockholders’ (Deficiency) Equity:
                               
 
Preferred stock — $.10 par value; authorized 16,936,704 shares:
                               
 
Series A convertible preferred stock, 199,380 shares designated — (liquidation preference $5.00 per share); issued and outstanding 198,000 shares at December 31, 2003 and 2004 and June 30, 2005 and 0 shares at June 30, 2005, pro forma
    972,311       972,311       972,311        
 
Common stock — $.001 par value; authorized 30,000,000 shares; issued and outstanding 1,684,760 shares at December 31, 2003 and 1,809,758 shares at December 31, 2004 and June 30, 2005 and 6,513,164 shares at June 30, 2005, pro forma
    1,685       1,810       1,810       6,513  
 
Additional paid-in capital
    5,119,923       10,981,455       10,209,995       20,604,675  
 
Notes receivable for stock subscriptions
    (69,000 )     (69,000 )            
 
Deferred compensation
    (22,500 )     (159,300 )     (143,370 )     (143,370 )
 
Accumulated deficit
    (10,287,817 )     (13,906,963 )     (16,716,060 )     (16,716,060 )
                         
   
Stockholders’ (Deficiency) Equity
    (4,285,398 )     (2,179,687 )     (5,675,314 )     3,751,758  
                         
   
Total Liabilities and Stockholders’ (Deficiency) Equity
  $ 431,755     $ 7,096,149     $ 4,997,418     $ 4,997,418  
                         
See accompanying notes to financial statements

F-3


 

ELECTRO-OPTICAL SCIENCES, INC.
STATEMENTS OF OPERATIONS
                                           
    Year Ended   Six Months Ended
         
    December 31,   December 31,   December 31,   June 30,   June 30,
    2002   2003   2004   2004   2005
                     
    (audited)   (audited)   (audited)   (unaudited)   (unaudited)
Revenue from grants
  $ 547,290     $     $     $     $  
                               
Operating expenses:
                                       
 
Cost of grant revenue
    563,598                          
 
General and administrative expenses
    511,225       1,034,397       1,234,210       639,079       995,931  
 
Research and development
    404,331       828,239       1,891,551       693,052       1,545,824  
                               
Operating loss from continuing operations
    (931,864 )     (1,862,636 )     (3,125,761 )     (1,332,131 )     (2,541,755 )
                               
Interest income
    (2,189 )     (1,373 )     (27,935 )     (543 )     (62,769 )
Interest expense
    10,117       76,923       94,976       82,340        
                               
      7,928       75,550       67,041       81,797       (62,769 )
                               
Loss from continuing operations
    (939,792 )     (1,938,186 )     (3,192,802 )     (1,413,928 )     (2,478,986 )
Loss from discontinued operations
    (201,259 )     (11,917 )     (426,344 )     (101,853 )     (330,111 )
                               
Net loss
    (1,141,051 )     (1,950,103 )     (3,619,146 )     (1,515,781 )     (2,809,097 )
Less:
                                       
 
Preferred stock deemed dividends
    214,245       321,830       676,218       242,693       719,064  
 
Preferred stock accretion
    180,009       25,228       322,800       25,228       842,260  
Stock distribution of preferred Series B shares
          101,700                      
                               
Net Loss Attributable to Common Stockholders
  $ (1,535,305 )   $ (2,398,861 )   $ (4,618,164 )   $ (1,783,702 )   $ (4,370,421 )
                               
Net loss per share, basic and diluted:
                                       
Continuing operations
    (0.87 )     (1.48 )     (2.37 )     (0.98 )     (2.23 )
Discontinued operations
    (0.13 )     (0.01 )     (0.24 )     (0.06 )     (0.18 )
                               
Basic and diluted net loss per common share
  $ (1.00 )   $ (1.49 )   $ (2.61 )   $ (1.04 )   $ (2.41 )
                               
Basic and diluted weighted average number of shares outstanding
    1,534,760       1,614,897       1,766,608       1,722,743       1,809,758  
                               
Pro forma basic and diluted net loss per common share (unaudited)
                  $ (0.91 )           $ (0.43 )
                               
Pro forma basic and diluted weighted average number of common shares outstanding (unaudited)
                    3,967,024               6,513,164  
                               
See accompanying notes to financial statements

F-4


 

ELECTRO-OPTICAL SCIENCES, INC.
STATEMENT OF STOCKHOLDERS’ (DEFICIENCY) EQUITY
Years ended December 31, 2002, 2003 and 2004, and the six months ended June 30, 2005 (unaudited)
                                                                         
    Convertible                            
    Preferred Stock                        
    Series A   Common Stock   Additional               Total
            Paid-In   Notes   Deferred   Accumulated   Stockholders’
    Shares   Amount   Shares   Amount   Capital   Receivable   Compensation   Deficit   (Deficiency)
                                     
Balance at January 1, 2002
    198,000     $ 972,311       1,534,760     $ 1,535     $ 2,932,174             $ (117,000 )   $ (7,196,663 )   $ (3,407,643 )
Amortization of deferred compensation
                                                    72,000               72,000  
Net loss
                                                            (1,141,051 )     (1,141,051 )
Preferred stock accretion
                                    (180,009 )                             (180,009 )
                                                       
Balance at December 31, 2002
    198,000     $ 972,311       1,534,760     $ 1,535     $ 2,752,165           $ (45,000 )   $ (8,337,714 )   $ (4,656,703 )
                                                       
Preferred stock accretion
                                    (25,228 )                             (25,228 )
Amortization of deferred compensation
                                                    22,500               22,500  
Issuance of common stock in exchange for notes receivable
                    150,000       150       68,850       (69,000 )                      
Adjustment for reduction to liquidation value of Series B preferred stock
                                    2,329,000                               2,329,000  
Stock distribution of preferred Series B shares
                                    (101,700 )                             (101,700 )
Common stock options issued for consulting fees
                                    96,836                               96,836  
Net loss
                                                            (1,950,103 )     (1,950,103 )
                                                       
Balance at December 31, 2003
    198,000     $ 972,311       1,684,760     $ 1,685     $ 5,119,923     $ (69,000 )   $ (22,500 )   $ (10,287,817 )   $ (4,285,398 )
                                                       
Sale of common stock
                    124,998       125       137,375                               137,500  
Deferred compensation-stock option awards to employees
                                    159,300               (159,300 )              
Issuance of options to non-employee directors
                                    150,450                               150,450  
Preferred stock accretion
                                    (322,800 )                             (322,800 )
Warrants issued in connection with preferred Series C stock
                                    3,158,948                               3,158,948  
Beneficial conversion feature in connection with preferred Series C stock
                                    2,385,063                               2,385,063  
Issuance of options to consultants
                                    72,800                               72,800  
Issuance of warrants to consultant
                                    120,396                               120,396  
Amortization of deferred compensation
                                                    22,500               22,500  
Net loss
                                                            (3,619,146 )     (3,619,146 )
                                                       
Balance at December 31, 2004
    198,000     $ 972,311       1,809,758     $ 1,810     $ 10,981,455     $ (69,000 )   $ (159,300 )   $ (13,906,963 )   $ (2,179,687 )
                                                       
Preferred stock accretion
                                    (842,260 )                             (842,260 )
Value of options vesting on attainment of milestone
                                    70,800                               70,800  
Retirement of note receivable
                                            69,000                       69,000  
Amortization of deferred compensation
                                                    15,930               15,930  
Net loss
                                                            (2,809,097 )     (2,809,097 )
                                                       
Balance at June 30, 2005 (unaudited)
    198,000     $ 972,311       1,809,758     $ 1,810     $ 10,209,995     $     $ (143,370 )   $ (16,716,060 )   $ (5,675,314 )
                                                       
See accompanying notes to financial statements

F-5


 

ELECTRO-OPTICAL SCIENCES, INC.
STATEMENTS OF CASH FLOWS
                                                 
    Year Ended   Six Months Ended
         
    December 31,   December 31,   December 31,   June 30,   June 30,
    2002   2003   2004   2004   2005
                     
    (audited)   (audited)   (audited)   (unaudited)   (unaudited)
Cash flows from operating activities:
                                       
 
Loss from continuing operations
  $ (939,792 )   $ (1,938,186 )   $ (3,192,802 )   $ (1,413,928 )   $ (2,478,986 )
 
Loss from discontinued operations
    (201,259 )     (11,917 )     (426,344 )     (101,853 )     (330,111 )
                               
   
Net loss
  $ (1,141,051 )   $ (1,950,103 )   $ (3,619,146 )   $ (1,515,781 )   $ (2,809,097 )
                               
 
Adjustments to reconcile net loss to net cash used in operating activities:
                                       
     
Allowance for doubtful accounts
          (13,288 )     (9,000 )           (1,000 )
     
Depreciation and amortization
    33,329       30,987       35,860       14,578       25,098  
     
Noncash compensation and amortization of deferred compensation
    72,000       22,500       172,950       11,250       86,730  
     
Common stock options and warrant issued for consulting fees
          96,836       193,196              
     
Retirement of stock subscription receivable for consulting services
                            34,500  
     
Amortization of discount on marketable securities
                (10,001 )           (30,072 )
     
Imputed interest expense attributable to preferred Series C
          45,000                    
     
Imputed interest expense on bridge loan
                80,000       80,000        
     
Changes in operating assets and liabilities:
                                       
       
(Increase) decrease in receivables
    (3,326 )     53,585       20,662       (64,794 )     8,128  
       
Decrease (increase) in inventories
    67,279       (39,296 )     3,110       (8,826 )     (16,122 )
       
Decrease (increase) in prepaid expenses and other current assets
    6,060       (3,464 )     (36,211 )     (4,768 )     9,293  
       
Deferred registration costs
                            (79,169 )
       
Increase (decrease) in accounts payable and accrued expenses
    237,660       137,414       (7,676 )     (76,936 )     5,382  
       
(Decrease) increase in deferred revenues
          (57,300 )     106,335       10,000       (106,335 )
       
Increase (decrease) in other current liabilities
    44,373       (21,879 )     5,308       (11,976 )     (17,284 )
                               
       
Net cash used in operating activities
    (683,676 )     (1,699,008 )     (3,064,613 )     (1,567,253 )     (2,889,948 )
                               
Cash flows from investing activities:
                                       
 
Patent costs
          (5,986 )     (3,166 )     (2,712 )     (2,822 )
 
Purchases of property and equipment
          (2,432 )     (88,884 )     (6,050 )     (81,337 )
 
Redemption (purchase) of marketable securities
    518,050             (6,584,750 )           3,007,110  
                               
       
Net cash provided by (used in) investing activities
    518,050       (8,418 )     (6,676,800 )     (8,762 )     2,922,951  
                               
Cash flows from financing activities:
                                       
 
Proceeds from issuance of Series C preferred stock
          1,500,000       9,171,480       1,100,000        
 
Expenses related to Series C preferred stock offering
          (252,278 )     (447,553 )            
 
Proceeds from (repayment of) notes payable to stockholders
          48,000       (48,000 )            
 
Proceeds from issuance of notes payable
          520,000       920,000       920,000        
 
Proceeds from sale of common stock
                137,500       137,500        
 
Payment for stock subscription receivable
                                34,500  
                               
       
Net cash provided by financing activities
          1,815,722       9,733,427       2,157,500       34,500  
                               
Net (decrease) increase in cash and cash equivalents
    (165,626 )     108,296       (7,986 )     581,485       67,503  
Cash and cash equivalents at beginning of period
    174,021       8,395       116,691       116,691       108,705  
                               
Cash and cash equivalents at end of period
  $ 8,395     $ 116,691     $ 108,705     $ 698,176     $ 176,208  
                               
Supplemental Cash Flow Information:
                                       
Cash paid for interest
  $     $ 24,378     $ 14,976     $     $  
Supplemental Schedule of Noncash Financing Activities:
                                       
Notes payable exchanged for Series C preferred stock
  $     $ 505,000     $ 1,015,000     $     $  
Notes receivable received for common stock
  $     $ 69,000     $     $     $  
Preferred stock accretion
  $ 180,009     $ 25,228     $ 322,800     $ 25,228     $ 842,260  
Reduction to liquidation value Series B preferred stock
          $ 2,329,000                          
Beneficial conversion feature in connection with Series C preferred stock
                  $ 2,385,063                  
Fair value of warrants issued in connection with Series C preferred stock
                  $ 3,158,948                  
Accrued registration costs
                                  $ 672,873  
Reclassification of inventories and patents to assets held for sale
                                  $ 156,677  
See accompanying notes to financial statements

F-6


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS
(In thousands, except for share and per share data)
(Information for the six months ended June 30, 2004 and 2005 is unaudited)
1. PRINCIPAL BUSINESS ACTIVITIES AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
Organization and Business
      Electro-Optical Sciences, Inc., a Delaware corporation (the “Company”) is focused on the design and development of a non-invasive, point-of-care instrument for assisting in the early diagnosis of melanoma. The Company has entered into a Protocol Agreement with the Food and Drug Administration (FDA) which is an agreement for the conduct of the pivotal trial and to establish the safety and effectiveness of the MelaFind® device. Upon obtaining premarket approval, or PMA, from the FDA, the Company plans to launch MelaFind® in the United States.
      To date the Company has not generated any revenues from MelaFind®. All of the Company’s historical revenues have come from activities and products that have since been discontinued, including our DIFOTI® product, a non-invasive imaging device for the detection of dental cavities. The Company discontinued all operations associated with its DIFOTI® product effective as of April 5, 2005, in order to focus its resources on the development and commercialization of MelaFind®. The Company is currently seeking a buyer for the DIFOTI® assets, and does not expect to have any significant continuing responsibility for the DIFOTI® business after the sale of the DIFOTI® assets. (See note 12)
Interim Financial Statements
      The accompanying balance sheet as of June 30, 2005, and the statements of operations, stockholders’ equity (deficiency) and cash flows for the six months ended June 30, 2004 and 2005 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company’s financial position and results of operations and cash flows for the six months ended June 30, 2004 and 2005. The financial data and other information disclosed in these notes to financial statements related to the six month periods are unaudited. The results for the six months ended June 30, 2005 are not necessarily indicative of the results to be expected for the year ending December 31, 2005.
Pro Forma Balance Sheet
      The Pro Forma Balance Sheet gives effect as of June 30, 2005 to the conversion of all of the Company’s outstanding preferred stock into 3,398,105 shares of common stock which will occur upon the closing of the proposed initial public offering. Upon such conversion, the deemed dividends on the convertible preferred stock will be forfeited. Additionally, it is assumed for pro forma purposes that 2,610,643 of the Company’s warrants to purchase the Company’s common stock will be exchanged for a total of 1,305,321 shares of the Company’s common stock based on an exchange ratio of one share of the Company’s common stock for every two shares of the Company’s common stock purchaseable under the warrants and will occur prior to the closing of the proposed initial public offering.
Reverse Stock Split
      The Board of Directors approved on May 13, 2005, a one-for-two reverse stock split, which will become effective upon the earlier of the conversion of the preferred stock or September 30, 2005. All references to common stock, common shares outstanding, average number of common shares outstanding, per share amounts, common stock options and warrants in these financial statements and notes to financial statements have been restated to reflect the one-for-two common stock reverse split on a retroactive basis.

F-7


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
Cash and Cash Equivalents
      The Company maintains cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses on these accounts. Cash equivalents include all highly-liquid debt instruments with an original maturity of three months or less at the date of acquisition.
Marketable Securities
      Marketable securities consist of debt securities that the Company has the intent and ability to hold to maturity. The Company classifies the marketable securities as held-to-maturity in accordance SFAS No. 115, “Accounting for Certain Investments in Debt and Equity Securities.” Held-to-maturity securities are recorded at amortized cost.
Accounts Receivable
      Accounts receivable are reported at their outstanding unpaid principal balances reduced by an allowance for doubtful accounts. The Company estimates doubtful accounts based on historical bad debts, factors related to specific customers’ ability to pay and current economic trends. The Company writes off accounts receivable against the allowance when a balance is determined to be uncollectible.
Inventories
      Inventories, which consist primarily of DIFOTI® supplies, are stated at the lower of cost, determined by the first-in, first-out method, or market.
Assets Held for Sale
      Assets held for sale at June 30, 2005 consisted of DIFOTI® related inventories and patents.
Deferred Registration Costs
      The costs associated with the Company’s proposed initial public offering have been recorded as deferred registration costs and will reduce additional paid-in capital if the offering is effective. Should the offering not be consummated, the deferred registration costs will be recognized as a charge to operations.
Property and Equipment
      Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the lesser of the assets’ useful lives or the remaining term of the lease.
Patents
      Patents are carried at cost less accumulated amortization which is calculated on a straight-line basis over a period of 15 years.
Revenue Recognition
      During April 2005, the Company discontinued the sale of the DIFOTI® product line. (Note 12). Revenue from DIFOTI® product sales was recognized at the time of delivery and acceptance, and after consideration of all the terms and conditions of the customer contract. Certain of the Company’s products which were being sold prior to December 31, 2004 included a 30-day return policy. Revenue on these products was recognized after the shipment was made and the 30-day return period had elapsed. Effective January 1, 2005 all products were sold without a right of return and revenue was therefore recognized

F-8


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
upon shipment. Deferred revenues at December 31, 2004 consisted of revenues that were billed and paid in advance of the shipment of the product.
      The Company has not received FDA approval for the sale of MelaFind® and has had no revenues from products other than DIFOTI®.
      Grant revenue generated in 2002 represents federal grants received by the Company in conjunction with an undertaking to perform certain research. The cost of grant revenue consists primarily of payroll and related costs amounting to $564.
Warranty Costs
      The Company generally warranted its only commercialized product, DIFOTI®, for one year after the sale had been completed. Through March 31, 2005, warranty costs were de minimus, and were recorded by the Company as incurred. During the quarter ended June 30, 2005, in connection with the discontinuance of its DIFOTI® product line, the Company recorded a reserve for warranty expense in accordance with the requirements of Statement of Financial Accounting Standards No. 5 “Accounting for Contingencies” (SFAS No. 5), in the amount of $20 since the Company believes it is probable that such discontinuance will lead to warranty claims. As of June 30, 2005, prior sales of approximately $200 were subject to possible warranty claims.
Income Taxes
      Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the amounts of existing assets and liabilities recorded in the financial statements and their respective tax bases and the benefits arising from the realization of operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized.
Estimates
      The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires the use of estimates and assumptions by management that affect reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.
Long-lived Assets
      The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An asset is considered to be impaired when the sum of the undiscounted future net cash flows expected to result from the use of the asset and its eventual disposition exceeds its carrying amount. The amount of impairment loss, if any, is measured as the difference between the net book value of the asset and its estimated fair value.
Research and Development
      Research and development costs are expensed as incurred.

F-9


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
Stock-Based Compensation
      The Company applies the intrinsic-value method of accounting prescribed by the Accounting Principles Board (APB) Opinion No. 25 and related interpretations to account for the Company’s fixed-plan employee stock options. Under this method, compensation expense is recorded on the date of grant only if the then current market price of the underlying stock exceeded the exercise price. Statement of Financial Accounting Standards (SFAS) No. 123, Accounting for Stock-Based Compensation, as amended by SFAS No. 148, Accounting for Stock-Based Compensation, Transition and Disclosure, established accounting and disclosure requirements using a fair-value based method of accounting for stock-based employee compensation plans. As allowed by SFAS No. 123 and No. 148, the Company has elected to continue to apply the intrinsic-value based method of accounting for employee stock options described above, and has adopted only the disclosure requirements of SFAS No. 123. Had the Company elected to recognize compensation cost based on the fair value of the options granted at the grant date, as prescribed by SFAS No. 123, the Company’s net loss and net loss per share would have been adjusted to the pro forma amounts indicated below:
                                         
    December 31,   June 30,
         
    2002   2003   2004   2004   2005
                     
Net loss attributable to common stockholders, as reported
  $ (1,535 )   $ (2,399 )   $ (4,618 )   $ (1,784 )   $ (4,370 )
Add: stock-based employee compensation included in reported net loss, net of income tax effect
    72       23       173       11       87  
Deduct: stock-based employee compensation expense determined under fair-value-based method, net of related tax effect
    (75 )     (65 )     (186 )     (8 )     (90 )
                               
Pro forma net loss
  $ (1,538 )   $ (2,441 )   $ (4,631 )     (1,781 )   $ (4,373 )
                               
Basic and diluted loss per share, as reported
  $ (1.00 )   $ (1.49 )   $ (2.61 )   $ (1.04 )   $ (2.41 )
                               
Basic and diluted loss per share, pro forma
  $ (1.00 )   $ (1.51 )   $ (2.62 )   $ (1.04 )   $ (2.42 )
                               
      The per share weighted-average fair value of stock options granted during 2002, 2003 and 2004 was $.26, $.34, and $3.00, respectively, on the dates of grant using the Black-Scholes option-pricing model.
      During the six months ended June 30, 2005, the Company did not grant any stock options. The per share weighted average fair value of stock options granted during the six months ended June 30, 2004 was determined using the Black-Scholes option pricing model resulting in a weighted average fair value of $0.25 per share. The following weighted-average assumptions were used:
                                         
    December 31,   June 30,
         
    2002   2003   2004   2004   2005
                     
Expected volatility
    1 %     1 %     60 %     60 %      
Risk-free interest rate
    4.52 %     4.52 %     3.17 %     3.39 %        
      to       to       to                  
      5.43 %     5.43 %     3.94 %                
Expected option life (in years)
    10       10       5       5          
Expected dividend yield
    0 %     0 %     0 %     0 %        

F-10


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
      Options or warrants issued to non-employees for services are recorded at fair value and accounted for in accordance with Emerging Issues Task Force (EITF) No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. For equity instruments that are not immediately vested, compensation cost is measured on the date such instruments vest or a performance commitment, as defined in EITF 96-18, is reached. The costs are classified in the accompanying statements of operations based on the nature of the services performed.
Deferred Compensation
      Deferred compensation attributable to unvested common stock options is measured at the measurement date for the respective grants, and reflected as a deduction from stockholders’ equity. Compensation expense is recognized ratably over the vesting period.
Financial Instruments
      The Company’s financial instruments consist principally of cash and cash equivalents, marketable securities, accounts receivable and accounts payable. The Company believes the financial instruments’ recorded values approximate current values because of their nature and respective durations. The Company maintains cash in bank deposit accounts, which, at times, may exceed federally insured limits. The Company has not experienced any losses on these accounts.
Net Loss per Common Share
      Net loss per share is presented in accordance with the provisions of SFAS No. 128, “Earnings Per Share” (EPS). Basic EPS excludes dilution for potentially dilutive securities and is computed by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted EPS gives effect to dilutive options, warrants and other potential common shares outstanding during the period. Diluted net loss per common share is equal to basic net loss per common share since all potentially dilutive securities are anti-dilutive for each of the periods presented. Diluted net loss per common share for the years ended December 31, 2002, 2003 and 2004 does not include the effects of options to purchase 142,581, 290,678 and 965,203 shares of common stock, respectively and 407,182 and 899,875 shares for the six months ended June 30, 2004 and 2005 respectively; 690, 369,993 and 2,758,923 common stock warrants for the years ended December 31, 2002, 2003 and 2004, respectively, and 673,662 and 2,758,923 common stock warrants for the six months ended June 30, 2004 and 2005, respectively.
      The pro forma basic and diluted net loss per common share for the year ended December 31, 2004 and for the six months ended June 30, 2005 gives effect to the conversion of the existing shares of preferred stock into 3,398,105 shares of common stock at the conversion ratios which would apply upon consummation of the proposed initial public offering and the exchange of 2,610,643 warrants for 1,305,321 shares of common stock as described in Note 9. In addition, the net loss attributable to the Company’s common stockholders used in the computation of basic and diluted net loss per share for the unaudited pro forma net loss attributable to the Company’s common stockholders has been adjusted to reverse the accretion on the Company’s preferred stock and also excludes the preferred stock dividends for the respective periods.
Recently Issued Pronouncements
      In December 2004, the Financial Accounting Standards Board (FASB) issued the revised SFAS No. 123, Share-Based Payment (SFAS 123R), which addresses the accounting for share-based payment transactions in which the Company obtains employee services in exchange for (a) equity instruments of the Company or (b) liabilities that are based on the fair value of the Company’s equity instruments or that may be settled by the issuance of such equity instruments. SFAS 123R eliminates the

F-11


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
ability to account for employee share-based payment transactions using APB No. 25 and requires instead that such transactions be accounted for using the grant-date fair value based method. SFAS 123R will be effective as of the beginning of the first interim or annual reporting period that begins after December 15, 2005 (January 1, 2006 for the Company) and applies to all awards granted or modified after the effective date. In addition, compensation cost for the unvested portion of previously granted awards that remain outstanding on the effective date shall be recognized on or after the effective date, as the related services are rendered, based on the awards’ grant-date fair value as previously calculated for the pro-forma disclosure under SFAS 123. The Company expects that upon the adoption of SFAS 123R it will apply the modified prospective application transition method, as permitted by the statement. Under such transition method, upon the adoption of SFAS 123R, the Company’s financial statements for periods prior to the effective date of the statement will not be restated. The impact of this statement on the Company’s financial statements or its results of operations in 2005 and beyond will depend upon various factors, among them, its future compensation strategy. The Company expects that the effect of applying this statement on its results of operations in 2005 as it relates to existing option plans would not be materially different from the SFAS 123 pro forma effect previously reported.
      In March 2004, the FASB issued EITF Issue No. 03-1, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments,” which provides new guidance for assessing impairment losses on debt and equity investments. Additionally, EITF Issue No. 03-1 includes new disclosure requirements for investments that are deemed to be temporarily impaired. In September 2004, the FASB delayed the accounting provisions of EITF Issue No. 03-1; however, the disclosure requirements remain effective and have been adopted by the Company in the financial statements. The Company will evaluate the effect, if any, of EITF Issue No. 03-1 when final guidance is released.
2. MARKETABLE SECURITIES:
      The Company’s investments mature within one year. Investments in marketable securities are summarized as follows at December 31, 2004 and June 30, 2005:
                                                 
    December 31, 2004   June 30, 2005
         
    Gross       Gross    
    Unrealized   Fair   Amortized   Unrealized   Fair   Amortized
    Loss   Value   Cost   Loss   Value   Cost
                         
Corporate commercial paper
  $     $ 2,500     $ 2,500     $     $     $  
Corporate debt
    (10 )     2,497       2,507       (2 )     2,024       2,026  
United States Treasury note
    (8 )     1,580       1,588       (7 )     1,585       1,592  
                                     
    $ (18 )   $ 6,577     $ 6,595     $ (9 )   $ 3,609     $ 3,618  
                                     
3. PROPERTY AND EQUIPMENT:
      Property and equipment, at cost, consists of the following:
                                 
    December 31,        
        June 30,   Estimated
    2003   2004   2005   Useful Life
                 
Leasehold improvements
  $ 23     $ 32     $ 65       5-10 years  
Laboratory and research equipment
    61       119       119       5 years  
Office furniture and equipment
    113       135       184       5 years  
                         
      197       286       368          
Less accumulated depreciation and amortization
    179       197       213          
                         
    $ 18       89     $ 155          
                         

F-12


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
      Depreciation expense amounted to approximately $16, $15 and $18, for the years ended December 31, 2002, 2003 and 2004, respectively and $6 and $15 for the six months ended June 30 2004 and 2005 respectively.
4. PATENTS:
      Patents are shown in the accompanying balance sheets net of accumulated amortization of $83 and $101 at December 31, 2003 and 2004, respectively. At June 30, 2005, accumulated amortization applicable to patents in use amounted to $61. In connection with the discontinuance of DIFOTI® operations in April 2005, patents with a net book value of $71 have been reclassified as assets held for sale. Amortization expense related to the patents was approximately $17, $17 and $18 for the years ended December 31, 2002, 2003 and 2004, respectively and $9 and $10 for the six months ended June 30, 2004 and 2005, respectively.
      The estimated future amortization expense related to the patents is as follows:
           
Year ended December 31,
       
 
2005
  $ 14  
 
2006
    10  
 
2007
    10  
 
2008
    10  
 
2009
    10  
Thereafter
    40  
       
    $ 94  
       
5. NOTES PAYABLE-STOCKHOLDERS:
      During 2003, the Company had notes payable to two of its stockholders totaling $48. These notes were payable in October 2004, bore interest at 6%, and were repaid during 2004. Interest expense amounted to approximately $1 and $2 for the years ended December 31, 2003 and 2004, respectively. In addition, the Company had a demand note payable to one of its stockholders in the amount of $15 with interest accruing at 12% per annum. During October 2004, the note and accrued interest of $1 were converted into 6,999 shares of Series C preferred stock.
6. COMMITMENTS AND CONTINGENCIES:
      The Company is obligated under two non cancelable operating leases for office space expiring June 2009 and November 2010. The leases are subject to escalations for increases in operating expenses. The approximate aggregate minimum future payments under these leases are due as follows:
           
Year ended December 31,
       
 
2005
  $ 205  
 
2006
    204  
 
2007
    213  
 
2008
    217  
 
2009
    170  
Thereafter
    105  
       
    $ 1,114  
       

F-13


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
      Rent expense charged to operations amounted to approximately $88, $113 and $110 for the years ended December 31, 2002, 2003 and 2004, respectively, and $54 and $94 for the six months ended June 30, 2004 and 2005, respectively.
      During January 2004, the Company entered into an employment agreement with its President and Chief Executive Officer through December 31, 2005, which provides for a base salary of $175, stock options and performance bonuses. The agreement provides for automatic one year renewal terms.
      During January 2004 the Company amended its employment agreement with its former president, who now holds the title Chief Science and Technology Officer. The agreement was originally entered into in May 2003 with a three-year term. The agreement now includes a salary of $175 and provides for stock options and performance bonuses. As of May 31, 2005, this former employee is now a consultant to the Company.
      The Company had been involved in various claims and legal actions arising in the ordinary course of business. The ultimate outcome of these matters did not have a material adverse impact on the financial position of the Company or the results of its operations.
7. EMPLOYEE BENEFIT PLAN:
      The Company has a defined contribution plan under Section 401(k) of the Internal Revenue Code covering all qualified employees. An officer of the Company serves as trustee of the plan. The Company provides a matching contribution of up to 3% of each employee’s salary. Contributions to this plan amounted to approximately $29, $12 and $25 for the years ended December 31, 2002, 2003 and 2004, respectively, and $11 and $15 for the six months ended June 30, 2004 and 2005, respectively.
8.  STOCKHOLDERS’ (DEFICIENCY) EQUITY AND REDEEMABLE PREFERRED STOCK:
      During January 2003, the Company received $180 in exchange for issuing a convertible promissory note bearing interest at 10% per annum, The note was convertible at a discount of 20% on the next round of financing. In June 2003, the note was converted into Series C redeemable convertible preferred stock. (See discussion below.) Upon conversion of the note the Company recorded a charge of $45 to reflect the value of the beneficial conversion of the shares since the shares were converted at $1.81 per share, a 20% discount. In addition, the Company granted the note holder five-year warrants to purchase 25% of the total number of securities issued upon conversion of the note, which amounted to 99,558 shares (or 24,890 warrants), at an exercise price equal to the per share price of the next financing as defined in the loan agreement. The value of these warrants was de minimus. For the year ended December 31, 2003, interest on these notes amounted to approximately $8.
      During February 2003, certain stockholders loaned the Company $325 bearing interest at 12% per annum. In June 2003, these loans were converted into 143,802 shares of Series C redeemable convertible preferred stock at $2.26 per share. For the year ended December 31, 2003, interest on these notes amounted to approximately $21.
      During June 2003, the Company completed a private placement whereby investors agreed to acquire up to 1,400,000 preferred Series C units. Each unit consists of one share of Series C redeemable convertible preferred stock and one warrant to purchase one share of common stock at an exercise price of $13.00 per share. Of the 1,400,000 units, the first tranche of 663,717 units was sold for an aggregate of $1,500. Costs associated with this issuance amounted to $252. This amount will be accreted to the Series C over the redemption period. For the year ended December 31, 2003, $25 was accreted. The value of the warrants was de minimus.

F-14


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
      In order to complete the June 2003 private placement, the Series A and B stockholders consented to modifications to certain of their rights, preferences, and privileges. The Series A preferred shares were split 1,000 for 1 and due to the anti-dilution provision, the conversion ratio of Series A was changed to 0.5818 to 1 (totaling 16,202 shares of common stock). Additionally, the Company granted a stock distribution of 45,000 shares of Series B preferred stock to the Series B stockholders, valued at $102 or $2.26 per share. As a result of these modifications, the Company adjusted the carrying amount of the Series B preferred stock. Due to the anti-dilution provision, the conversion ratio of Series B was changed to 0.5796 to 1 (totaling 79,043 shares of common stock). The Series C redeemable convertible preferred stock converts to common stock at a ratio of 0.50 to 1.
      In connection with the private placement, 150,000 shares of common stock were sold to the promoters, who are related parties, at $.46 per share. Notes of $69 were received for this purchase and is shown as a reduction in stockholders’ equity (deficiency). The note bears interest at 3.06% and is due June 20, 2008. Interest income amounted to approximately $2 and $1 for the years ended December 31, 2004 and 2003, respectively. During June 2005, the notes of $69 were retired by a cash payment and consulting services rendered.
      During 2004, the second tranche of the Series C private placement was completed and an additional 486,725 of Series C units were issued for total proceeds of $1,100. An additional 427 units were distributed in order to comply with minimum ownership provisions. The value of the distribution was de minimus. In order to induce the investment in this second tranche, the Company issued additional warrants to purchase 60,840 shares of Series C redeemable convertible preferred stock at a price of $4.52 per share. These warrants were valued at $179.
      During May 2004, the Company obtained bridge loans in the amount of $1,000 from related parties. The loans bear interest at 1.57% and were payable on December 31, 2004. During October 2004 these loans were converted into 442,469 preferred Series C units at a price of $2.26 per unit. The warrants were valued at $327. The Company also sold approximately 125,000 shares of common stock to the lenders at $.46 per share for $57. The Company ascribed a value to the common stock and recorded an imputed interest charge of $80.
      During October 2004, the Company completed a second private placement and sold 3,578,081 preferred Series C units for total proceeds of approximately $8,100 at a price of $2.26 per unit. The warrants were valued at $2,653. Costs of the Series C private placement amounted to approximately $448. This amount will be accreted to the Series C over the redemption period. For the year ended December 31, 2004, $71 was accreted.
      During 2004, the Company issued 4,507,702 shares of Series C redeemable convertible preferred stock with 2,253,792 warrants to purchase common stock at $13.00 per share and 60,840 Series C redeemable convertible preferred stock warrants at an exercise price of $4.52 per share for gross proceeds of $10,186. The net proceeds of $9,738 were allocated to redeemable convertible preferred stock and additional paid-in capital based on the relative fair values of the preferred stock and warrants. The fair value of the warrants was determined using the Black-Scholes method. The assumptions used to value these warrants are described in Note 9. The Company recorded a beneficial conversion feature of $2,385 which is being accreted to redemption for the Series C redeemable convertible preferred stock based on the earliest redemption date of June 2008.
      The total accretion to redemption value for the Series C amounted to $25, $323, and $842 for the years ended December 31, 2003 and 2004 and the six months ended June 30, 2005, respectively.

F-15


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
      The rights, preferences, and privileges of the Series B and C redeemable preferred stock are as follows:
Voting Rights
      All holders of redeemable convertible preferred stock have voting rights equal to the number of shares of common stock into which the respective preferred stock is convertible.
Liquidation Preference
      In the event of liquidation, dissolution, or winding-up of the Company, and before any distribution to common stockholders, the holders of Series B and C redeemable convertible preferred stock are entitled to receive $2.26 per share plus all accrued but unpaid dividends.
Deemed Dividends
      Dividends on the Series B and Series C redeemable convertible preferred stock may be declared at the discretion of the board of directors at an annual rate equal to 10%, as adjusted, of the accreted value per share and shall be payable in preference and priority to any declaration or payment of any distribution on Series A preferred stock or common stock and will be cumulative. At December 31, 2004 and June 30, 2005 there are approximately $1,510 and $2,229 of deemed but unpaid dividends. In the event the preferred stock is converted into common stock, any related deemed dividends would be forfeited.
Redemption Provisions
      Pursuant to the modification of the Series B preferred stock terms adopted at the closing of the Series C private placement, the requirement to redeem the preferred shares, at the option of the holder, has been extended to June 2008. The redemption of Series B requires approval of the Series C shareholders. The preferred Series C stock is redeemable at the option of the holder, on the fifth and sixth anniversary of the first issuance of Series C preferred stock (June 2003). Series B has been classified as temporary equity at its redemption value; Series C has been so classified at its accreted value.
9. STOCK OPTIONS AND WARRANTS:
Warrants
      Warrants outstanding consist principally of warrants issued in connection with the Company’s Series C financing and generally expire seven years from the date of grant.
      During 2003, in connection with the sale of Series C redeemable convertible preferred stock, 356,851 warrants to purchase common stock at an exercise price of $13.00 per share were issued. The fair value of these warrants was determined to be de minimus using the Black-Scholes method. The assumptions used in determining the fair value were the following: common stock value per share of $0.46, warrant life of 7 years, a risk-free interest rate of 3.67%, and an expected volatility of 1%. The Company also issued 12,445 warrants to purchase shares of Series C redeemable convertible preferred stock at an exercise price of $4.52. The fair value of these warrants was determined to be de minimus using the Black-Scholes method assuming a stock price of $4.52 per share, warrant life of 5 years, a risk-free interest rate of 3.67%, and an expected volatility of 1%.
      During 2004, in connection with the sale of Series C redeemable convertible preferred stock, 2,253,792 warrants to purchase common stock at an exercise price of $13.00 per share were issued. The fair value of these warrants ranged from $0.02 to $1.48 using the Black-Scholes method. The assumptions used in determining the fair value were the following: common stock value per share ranged from $0.46 to

F-16


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
$4.00, warrant life of 7 years, a risk-free interest rate of 3.67%, and an expected volatility of 60%. The Company also issued 60,840 warrants to purchase shares of Series C redeemable convertible preferred stock at an exercise price of $4.52. The fair value of these warrants was determined to be $2.94 using the Black-Scholes method assuming a stock price of $4.52 per share, warrant life of 7 years, a risk-free interest rate of 3.67%, and an expected volatility of 60%. The total fair value of the aforementioned warrants issued in 2004 aggregated $3,159.
      During 2004, the Company issued a 5 year warrant to purchase 75,000 shares of common stock at an exercise price of $7.00 per share to one of its consultants. These warrants have been valued at $120 using the Black-Scholes method and was recorded as compensation expense. The assumptions used in determining the fair value were the following: common stock value per share of $4.00, warrant life of 5 years, a risk-free interest rate of 3.67%, and an expected volatility of 60%.
      Warrant activity during the periods indicated is as follows:
                 
        Weighted-
        Average
        Exercise
    Warrants   Price
         
Outstanding at January 1, 2002
    10,505     $ 10.00  
Expired
    (9,815 )     10.00  
             
Outstanding at December 31, 2002
    690     $ 10.00  
Granted
    369,303       12.72  
             
Outstanding at December 31, 2003
    369,993       12.70  
Granted
    2,389,620       12.60  
Expired
    (690 )     10.00  
             
Outstanding at December 31, 2004
    2,758,923     $ 12.61  
             
      There was no warrant activity during the six months ended June 30, 2005.
      On April 5, 2005, the Board of Directors approved, subject to stockholder approval, the issuance of 1,305,321 shares of the Company’s common stock in exchange for 2,610,643 outstanding warrants (a conversion ratio of one share of common stock for two warrants.) The Company considers this transaction to be an exchange of equity instruments at fair value which will have no net effect on stockholders’ equity. The fair value of the warrants was determined using the Black-Scholes method and assumed the following: common stock value of $10.00 per share, remaining warrant life of 6.25 years, risk-free interest rate of 3.2%, and an expected volatility of 60%.
Stock Options
      The Company has three stock option plans (the “Plans”) which allow the board of directors to grant incentives to employees, directors and collaborating scientists in the form of incentive stock options, nonqualified stock options and restricted stock. At December 31, 2004 and June 30, 2005, options to purchase 965,203 and 899,875 shares of common stock, respectively, at exercise prices ranging from $.40 to $10.00 per share are outstanding and are exercisable at various dates through 2013. The total number of shares reserved under the Company’s stock option plans is 1,000,000.
      In January 2003, the Company issued an option to acquire 24,209 shares of common stock at an exercise price of $1.00 per share valued at approximately $97 to outside consultants. During 2004, the Company issued options to acquire 27,750 shares of common stock at an exercise price of $.46 per share valued at approximately $73 to outside consultants. The fair value for these options granted to outside

F-17


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
consultants was calculated using the Black-Scholes method. For the options granted during 2004 to outside consultants, the assumptions used in the Black-Scholes model were: common stock valued ranged from $0.46 to $4.00, expected life of 5 years, risk-free interest rate ranged from 3.39% to 3.94%, and an expected volatility of 60%.
      During 2004 the Company issued 262,500 options to certain employees and Board members. The value of the options resulted in a charge to operations in the amount of $150 and $71 during the year ended December 31, 2004 and for the six months ended June 30, 2005, respectively. The share based compensation expense for these option grants represent the amount by which the fair value per common share of $4.00 exceeds the exercise price per share of $0.46.
      Stock option activity during the periods indicated is as follows:
                 
        Weighted-
        average
    Number   Exercise
    of Shares   Price
         
Outstanding at January 1, 2002
    128,050     $ 2.28  
Granted
    14,531       1.00  
             
Outstanding at December 31, 2002
    142,581       2.16  
Granted
    158,565       .94  
Expired/ Forfeited
    (10,468 )     .96  
             
Outstanding at December 31, 2003
    290,678       1.12  
Granted
    679,525       .46  
Expired/ Forfeited
    (5,000 )     1.00  
             
Outstanding at December 31, 2004
    965,203       .66  
Expired/ Forfeited
    (65,328 )     .89  
             
Outstanding at June 30, 2005
    899,875     $ .64  
             
Options exercisable at December 31, 2004
    428,729     $ .89  
             
Options exercisable at June 30, 2005
    446,675       .82  
             
      The following table summarizes information about fixed stock options outstanding at December 31, 2004:
                                         
    Options Outstanding    
        Options Exercisable
        Weighted-        
        average   Weighted-       Weighted-
        Remaining   average       average
Range of   Number   Contractual   Exercise   Number   Exercise
Exercise Prices   Outstanding   Life   Price   Exercisable   Price
                     
$.01-$.46
    694,525       4.7 years     $ .46       173,989     $ .46  
$.47-$1.00
    265,678       6.5 years       1.00       249,740       1.00  
$1.01-$10.00
    5,000       .4 years       10.00       5,000       10.00  
                               
$.01-$10.00
    965,203       5.7 years     $ .66       428,729     $ .89  
                               
      As of June 30, 2005, of the total 899,875 options outstanding, 445,701 of these options will vest upon the attainment of certain milestones and will be charged to operations based on the then current Company’s market price per share.
      The employment agreement with Dr. Gulfo includes three separate grants of common stock options. The first two stock option grants for a total of 81,753 shares of the Company’s common stock have fully

F-18


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
vested. The number of shares of the Company’s common stock subject to the third stock option can only be calculated at the time of PMA approval of MelaFind®. The number of shares under this option is equal to that number of shares of our common stock equal to four percent of the Company’s fully diluted capital stock at the time of PMA approval of MelaFind® minus the 81,753 options granted to Dr. Gulfo under the employment agreement.
      In May 2005, the Company amended option agreements for 125,000 shares in the aggregate of three key employees to immediately vest upon the completion of a successful initial public offering. The Company will record a charge to operations based upon the initial public offering price.
10.     INCOME TAXES:
      At December 31, 2004 and June 30, 2005, the Company had net operating loss carryforwards of approximately $12,208 and $15,017, respectively, available to offset future taxable income expiring at various dates through the year 2025. The Company’s ability to utilize its net operating losses may be significantly limited due to changes in the Company’s ownership as defined by federal income tax regulations. Without regard to any such limitations, the Company had a deferred tax asset of approximately $3,443, $4,883 and $6,007 at December 31, 2003, 2004 and June 30, 2005, respectively. Because the Company anticipates continued losses for the foreseeable future, the Company has recorded a 100% valuation allowance against its deferred income tax assets for all periods. The increase in the valuation allowance for the years ended December 31, 2002, 2003, 2004 and six months ended on June 30, 2005 amounted to $428, $753, $1,440 and $1,124, respectively.
11.     RELATED PARTY CONSULTING AGREEMENTS:
      The Company has in place the following consulting agreements with related parties.
Consulting Agreement with Breaux Castleman
      In June 2003, the Company entered into a consulting agreement with Breaux Castleman, the Chairman of the Company’s Board of Directors, for consulting services related to the FDA approval of MelaFind®, and the Company’s business and financial strategy. Under this agreement, Mr. Castleman receives compensation for each month of services rendered. The Company made payments pursuant to this consulting agreement $48 in 2003, $22 in 2004, and $12 through June 30, 2005. This consulting agreement is terminable by either party on 30 days’ written notice.
Consulting Agreement with Marek Elbaum, Ph.D.
      Pursuant to a consulting agreement effective as of May 31, 2005, the Company retained Marek Elbaum, Ph.D., the Company’s founder and former Chief Science and Technology Officer, as the Company’s Chief Scientist. In consideration of the services to be provided, the Company has agreed to pay Dr. Elbaum a monthly fee of $15. The term of this agreement extends for a period of two years and is automatically renewable for an additional one year period. In the event of a non-renewal, and in the event that Dr. Elbaum’s services terminate as a result of his death or disability, we will pay to Dr. Elbaum a termination fee of $100.
Consulting Agreement with Robert Friedman, M.D.
      Effective as of June 1, 2005, the Company retained the services of Robert Friedman, M.D., for an initial term of one year as a consultant, medical advisor to our Board of Directors, and in connection with the clinical testing of MelaFind®. In consideration for these services, Dr. Friedman will be paid at a rate of $5,000 per day. This consulting agreement is automatically renewed for successive one-year terms unless either party terminates the agreement at least 30 days prior to the expiration of the agreement.

F-19


 

ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO FINANCIAL STATEMENTS — (Continued)
Consulting Agreement with Gerald Wagner, Ph.D.
      On June 1, 2005, the Company entered into a consulting agreement with Gerald Wagner, Ph.D., a member of the Company’s Board of Directors, to direct our MelaFind® product development efforts and oversee the manufacturing process. The agreement ends three months following the initiation of the Company’s pivotal clinical trial of MelaFind®. The consulting agreement provides for a flat fee of $150,000, payable ratably over the course of the term, and a stock option grant to purchase 50,000 shares of the Company’s common stock, subject to and immediately after completion of the Company’s initial public offering at the public offering price per share.
12.     DISCONTINUED OPERATIONS AND ASSETS HELD FOR SALE:
      On March 9 through March 21, 2005, the Company was inspected by the FDA in connection with its DIFOTI® product, a non-invasive imaging device for the detection of dental cavities. On March 21, 2005, the Company was cited for failures to comply fully with FDA quality system regulation, or QSR, mandated procedures. These inspectional findings were discussed in a subsequent meeting with the FDA on April 28, 2005.
      The Company is in the process of addressing the deficiencies noted.
      The Company decided to discontinue all operations associated with its DIFOTI® product effective as of April 5, 2005, in order to focus its resources and attention on the development and commercialization of MelaFind®. The Company is currently seeking an acquirer for the DIFOTI® assets, and does not expect to have any significant continuing responsibility for the DIFOTI® business after its disposition.
      Losses attributable to DIFOTI® operations discontinued in April 2005 amounted to $201, $12, $426, $102, and $330 for the years ended December 31, 2002, 2003, 2004, and the six months ended June 30, 2004 and 2005, respectively.
      SFAS No. 144 requires that long-lived assets to be disposed by sale be measured at the lower of carrying amount or fair value less cost to sell. SFAS No. 144 also broadened the reporting of discontinued operations to include all components of an entity with operations that will be eliminated from ongoing operations of the entity in a disposal transaction. At June 30, 2005, assets held for sale consisted of DIFOTI® related inventories and patents.
      In accordance with the provisions of SFAS No. 144, the results of operations of the discontinued business have been reported as discontinued operations for all periods presented in the accompanying financial statements.

F-20


 

LOGO
3,000,000 Shares
Electro-Optical Sciences, Inc.
Common Stock
 
PROSPECTUS
 
       Until                     , 2005, all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.
Ladenburg Thalmann & Co. Inc. Stanford Group Company
                    , 2005


 

PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 13. Other Expenses of Issuance and Distribution.
      The following table sets forth the costs and expenses to be paid by the Registrant in connection with the sale of the shares of common stock being registered hereby. All amounts are estimates except for the SEC registration fee, the NASD filing fee and the NASDAQ National Market filing fee.
           
Securities and Exchange Commission registration fee
  $ 3,884  
NASD filing fee
    4,640  
NASDAQ National Market filing fee
    5,000  
Accounting fees and expenses
    275,000  
Legal fees and expenses
    585,000  
One percent nonaccountable underwriters expense
    330,000  
Printing and engraving expenses
    270,000  
Blue sky fees and expenses
    10,000  
Transfer agent and registrar fees and expenses
    15,000  
Miscellaneous
    191,476  
       
 
Total
  $ 1,690,000  
       
 
To be completed by amendment.
ITEM 14. Indemnification of Directors and Officers.
      Section 145 of the Delaware General Corporation Law permits a corporation to include in its charter documents, and in agreements between the corporation and its directors and officers, provisions expanding the scope of indemnification beyond that specifically provided by the current law.
      Article VIII of our third amended and restated certificate of incorporation provides for the indemnification of directors to the fullest extent permissible under Delaware law. Our fourth amended and restated certification of incorporation to be filed upon completion of this offering will contain similar indemnification provisions.
      Article IX of our second amended and restated bylaws provides for the indemnification of officers, directors or other agents acting on our behalf if such person acted in good faith and in a manner reasonably believed to be in and not opposed to our best interest and, with respect to any criminal action or proceeding, the indemnified party had no reason to believe his or her conduct was unlawful. Our third amended and restated bylaws to be filed upon completion of this offering will contain similar indemnification provisions.
      Prior to the completion of the offering, the Registrant intends to enter into Indemnification Agreements with each of its current directors and officers to provide such directors and officers additional contractual assurances regarding the scope of the indemnification set forth in the Registrant’s restated certificate of incorporation and amended and restated bylaws and to provide additional procedural protections. At present, there is no pending litigation or proceeding involving a director, officer or employee of the Registrant regarding which indemnification is sought. Reference is also made to Section 7 of the Underwriting Agreement, which provides for the indemnification of officers, directors and controlling persons of the Registrant against certain liabilities. The indemnification provision in the Registrant’s restated and amended certificate of incorporation, amended and restated bylaws and the indemnification agreements to be entered into between the Registrant and each of its directors and officers may be sufficiently broad to permit indemnification of the Registrant’s directors and officers for liabilities arising under the Securities Act.

II-1


 

      The Registrant has directors’ and officers’ liability insurance for securities matters prior to the closing of this offering.
      See also the undertakings set out in response to Item 17.
      Reference is made to the following documents filed as exhibits to this Registration Statement regarding relevant indemnification provisions described above and elsewhere herein:
         
Exhibit Document   Number
     
Underwriting Agreement
    1.1 *
Registrant’s Third Amended and Restated Certificate of Incorporation
    3.1  
Registrant’s Second Amended and Restated Bylaws
    3.3  
Second Amended and Restated Investors’ Rights Agreement dated October 26, 2004
    4.2  
Form of Indemnification Agreement
    10.1 *
 
To be filed by amendment.
ITEM 15. Recent Sales of Unregistered Securities.
  •  On June 20, 2003, we sold 75,000 shares of our common stock at a price of $0.46 per share to Dr. Robert Friedman, a former member of our board of directors, and 75,000 shares of our common stock at a price of $0.46 per share to Breaux Castleman, a member of our board of directors, and the chairman of our board.
 
  •  On June 20, 2003, we issued an aggregate of 45,000 shares of our Series B preferred stock to the 149 Series B preferred stock investors who originally purchased our Series B preferred stock in 2000 in consideration of certain amendments to their investment agreements.
 
  •  On June 20, 2003, we issued a warrant to purchase up to 24,890 shares of our Series C preferred stock at an exercise price of $2.26 per share to Koji Miyazaki, one of our Series C preferred stock investors.
 
  •  On June 20, 2003, we also issued a warrant to Dr. Marek Elbaum, a former member of our board of directors and former Chief Science and Technology Officer, to purchase up to 25,000 shares of our common stock at per share exercise price of $13.00.
 
  •  From June 20, 2003 through October 26, 2004, we issued an aggregate of 5,414,779 shares of our Series C preferred stock to 73 accredited investors for an aggregate consideration of $12,191,480.
 
  •  From June 20, 2003 through October 26, 2004, we issued warrants to purchase up to an aggregate of 2,610,643 shares of our common stock with an exercise price of $13.00 per share to certain purchasers of our Series C preferred stock.
 
  •  On February 2, 2004, we issued a warrant to purchase up to 121,681 shares of our Series C preferred stock with an exercise price $2.26 per share to Health Partners I, LLC.
 
  •  In May 2004, we issued 125,000 shares of our common stock at a per share purchase price of $0.46 to accredited investors who loaned an aggregate of $1,000,000 to the company, which loans were evidenced by convertible promissory notes, all of which converted into shares of our Series C preferred stock on October 26, 2004.
 
  •  On December 10, 2004, we issued a warrant to Allen & Company LLC to purchase up to 75,000 shares of our common stock at an exercise price of $7.00 per share in consideration of Allen & Company’s agreement to provide certain advisory services to us.
 
  •  From January 1, 2002 to May 15, 2005 we granted options to purchase 852,621 shares of our common stock to employees, directors and consultants under our 1996 Plan and 2003 Plan.

II-2


 

      The sales of the above securities were deemed to be exempt from registration under the Securities Act in reliance on Section 4(2) of the Securities Act, or Regulation D promulgated thereunder, or Rule 701 promulgated under Section 3(b) of the Securities Act, as transactions by an issuer not involving a public offering or transactions pursuant to compensatory benefit plans and contracts relating to compensation as provided under Rule 701. The recipients of securities in each of these transactions represented their intention to acquire the securities for investment only and not with view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the share certificates and instruments issued in such transactions. The sales of these securities were made without general solicitation or advertising. All recipients had adequate access, through their relationship with the Registrant, to information about the Registrant.
ITEM 16. Exhibits and Financial Statement Schedules.
      (a) The following exhibits are filed herewith:
         
Number   Exhibit Title
     
  1 .1*   Form of Underwriting Agreement.
 
  3 .1**   Third Amended and Restated Certificate of Incorporation.
 
  3 .2   Form of Amended and Restated Certificate of Incorporation of Registrant to be effective upon closing of the offering.
 
  3 .3**   Second Amended and Restated Bylaws of the Registrant as currently in effect.
 
  3 .4*   Form of Amended and Restated Bylaws of the Registrant to be effective upon closing of the offering.
 
  4 .1*   Specimen Stock Certificate.
 
  4 .2**   Second Amended and Restated Investor’s Rights Agreement dated as of October 26, 2004 by and among the Registrant and the parties listed therein.
 
  5 .1*   Opinion of Dreier LLP.
 
  10 .1*   Form of Indemnification Agreement for directors and executive officers.
 
  10 .2**   1996 Stock Option Plan.
 
  10 .3**   2003 Stock Incentive Plan, as amended.
 
  10 .4   2005 Stock Incentive Plan.
 
  10 .5**   Employment Agreement dated as of January 5, 2004 between the Registrant and Joseph V. Gulfo.
 
  10 .6**   Consulting Agreement dated as of May 31, 2005 between the Registrant and Marek Elbaum.
 
  10 .7**   Lease Agreement dated as of December 16, 1998, by and between the Registrant and Bridge Street Properties LLC, for office space located at One Bridge Street, Irvington, New York.
 
  10 .8**   First Amendment to the Lease Agreement dated as of May 17, 2001 by and between the Registrant and Bridge Street Properties LLC.
 
  10 .9**   Second Amendment to the Lease Agreement dated as of June 19, 2003 by and between the Registrant and Bridge Street Properties LLC.
 
  10 .10**   Lease Agreement dated as of November 23, 2004, by and between the Registrant and Bridge Street Properties LLC, for office space located at 3 West Main Street, Irvington, New York.
 
  10 .11   Consulting Agreement dated as of June 1, 2005 between the Registrant and Gerald Wagner Consulting, LLC.
 
  10 .12   Consulting Agreement dated as of June 20, 2003 between the Registrant and Breaux Castleman, as amended.
 
  10 .13   Consulting Agreement dated as of June 1, 2005 between the Registrant and Robert Friedman, M.D.
 
  10 .14*   Task Order Agreement dated as of July 13, 2005 between the Registrant and Battelle Memorial Institute.
 
  10 .15   Third Amendment dated as of June 6, 2005, by and between the Registrant and Bridge Street Properties LLC, for office space located at 1 Bridge Street, Irvington, New York.
 
  14 .1   Code of Business Conduct and Ethics.

II-3


 

         
Number   Exhibit Title
     
 
  23 .1   Consent of Eisner LLP, Independent Registered Public Accounting Firm.
 
  23 .2*   Consent of Counsel (included in Exhibit 5.1).
 
  24 .1**   Power of Attorney.
 
* To be filed by amendment.
**  Previously filed.
(b) Financial statement schedules are omitted because the information called for is not required or is shown either in the financial statements or the notes thereto.
ITEM 17. Undertakings.
      The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the Underwriting Agreement certificates in such denominations and registered in such names as required by the Underwriters to permit prompt delivery to each purchaser.
      Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the provisions described under Item 14 above, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
      The undersigned Registrant hereby undertakes that:
        (1) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective.
 
        (2) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-4


 

SIGNATURES
      Pursuant to the requirements of the Securities Act, the Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of New York, New York, on this 15th day of July, 2005.
  ELECTRO-OPTICAL SCIENCES, INC.
  By:  /s/ Joseph V. Gulfo
 
  Joseph V. Gulfo
  President and Chief Executive Officer
      Pursuant to the requirements of the Securities Act, this Registration Statement has been signed by the following persons in the capacities and on the date indicated.
             
Name   Title   Date
         
 
Principal Executive Officer:        
 
/s/ Joseph V. Gulfo
 
Joseph V. Gulfo
  President , Chief Executive Officer and Director   July 15, 2005
 
Principal Financial Officer and Principal Accounting Officer:        
 
/s/ Karen Krumeich
 
Karen Krumeich
  Vice President, Finance and Chief Financial Officer   July 15, 2005
 
Additional Directors:        
 
*
 
Breaux Castleman
  Director, Chairman of the Board of Directors   July 15, 2005
 
*
 
Sidney Braginsky
  Director   July 15, 2005
 
*
 
George C. Chryssis
  Director   July 15, 2005
 
*
 
Dan W. Lufkin
  Director   July 15, 2005
 
*
 
Gerald Wagner
  Director   July 15, 2005
 
*By:   /s/ Joseph V. Gulfo
 
Joseph V. Gulfo
Attorney-in-fact
       

II-5


 

EXHIBIT INDEX
         
Number   Exhibit Title
     
  1 .1*   Form of Underwriting Agreement.
 
  3 .1**   Third Amended and Restated Certificate of Incorporation.
 
  3 .2   Form of Amended and Restated Certificate of Incorporation of Registrant to be effective upon closing of the offering.
 
  3 .3**   Second Amended and Restated Bylaws of the Registrant as currently in effect.
 
  3 .4*   Form of Amended and Restated Bylaws of the Registrant to be effective upon closing of the offering.
 
  4 .1*   Specimen Stock Certificate.
 
  4 .2**   Second Amended and Restated Investor’s Rights Agreement dated as of October 26, 2004 by and among the Registrant and the parties listed therein.
 
  5 .1*   Opinion of Dreier LLP.
 
  10 .1*   Form of Indemnification Agreement for directors and executive officers.
 
  10 .2**   1996 Stock Option Plan.
 
  10 .3**   2003 Stock Incentive Plan, as amended.
 
  10 .4   2005 Stock Incentive Plan.
 
  10 .5**   Employment Agreement dated as of January 5, 2004 between the Registrant and Joseph V. Gulfo.
 
  10 .6**   Consulting Agreement dated as of May 31, 2005 between the Registrant and Marek Elbaum.
 
  10 .7**   Lease Agreement dated as of December 16, 1998, by and between the Registrant and Bridge Street Properties LLC, for office space located at One Bridge Street, Irvington, New York.
 
  10 .8**   First Amendment to the Lease Agreement dated as of May 17, 2001 by and between the Registrant and Bridge Street Properties LLC.
 
  10 .9**   Second Amendment to the Lease Agreement dated as of June 19, 2003 by and between the Registrant and Bridge Street Properties LLC.
 
  10 .10**   Lease Agreement dated as of November 23, 2004, by and between the Registrant and Bridge Street Properties LLC, for office space located at 3 West Main Street, Irvington, New York.
 
  10 .11   Consulting Agreement dated as of June 1, 2005 between the Registrant and Gerald Wagner Consulting, LLC.
 
  10 .12   Consulting Agreement dated as of June 20, 2003 between the Registrant and Breaux Castleman, as amended.
 
  10 .13   Consulting Agreement dated as of June 1, 2005 between the Registrant and Robert Friedman, M.D.
 
  10 .14*   Task Order Agreement dated as of July 13, 2005 between the Registrant and Battelle Memorial Institute.
 
  10 .15   Third Amendment dated as of June 6, 2005, by and between the Registrant and Bridge Street Properties LLC, for office space located at 1 Bridge Street, Irvington, New York.
  14 .1   Code of Business Conduct and Ethics.
 
  23 .1   Consent of Eisner LLP, Independent Registered Public Accounting Firm.
 
  23 .2*   Consent of Counsel (included in Exhibit 5.1).
 
  24 .1**   Power of Attorney.
 
  To be filed by amendment.
**  Previously filed.

EXHIBIT 3.2 FOURTH AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF ELECTRO-OPTICAL SCIENCES, INC. Electro-Optical Sciences, Inc., a corporation organized and existing under the laws of the State of Delaware (the "Corporation"), certifies that: A. The name of the Corporation is Electro-Optical Sciences, Inc. The Corporation's original Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on September 3, 1997. B. The Corporation's Amended and Restated Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on June 19, 2003. C. The Corporation's Second Amended and Restated Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on April 7, 2004. D. The Corporation's Third Amended and Restated Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on October 26, 2004. E. This Fourth Amended and Restated Certificate of Incorporation of the Corporation was duly adopted in accordance with Sections 242 and 245 of the General Corporation Law of the State of Delaware (the "DGCL"), and restates, integrates and further amends the provisions of the Corporation's Third Amended and Restated Certificate of Incorporation as follows: ARTICLE I The name of the Corporation is Electro-Optical Sciences, Inc. ARTICLE II The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the DGCL. The address of the Corporation's registered office in the State of Delaware is c/o United Corporate Services, Inc., 15 East North Street, in the City of Dover, County of Kent, State of Delaware. The name of the registered agent at such address is United Corporate Services, Inc. ARTICLE III The total number of shares of stock that the corporation shall have authority to issue is 40,000,000 consisting of 30,000,000 shares of Common Stock, $0.001 par value per share, and 10,000,000 shares of Preferred Stock, $0.10 par value per share. 1

The Preferred Stock may be issued in one or more series at such time or times and for such consideration or considerations as the Board of Directors of the Corporation may determine. Each series shall be so designated as to distinguish the shares thereof from the shares of all other series and classes. Except as to the relative preferences, powers, qualifications, rights and privileges which may be determined by the Board of Directors of the Corporation as described below, all shares of Preferred Stock shall be identical. Except as and to the extent otherwise specified herein, different series of Preferred Stock shall not be construed to constitute different classes of shares for the purpose of voting by class. The Board of Directors of the Corporation is expressly authorized by a vote of all of the members of the Board of Directors then in office, subject to the limitations prescribed by law and the provisions of this Fourth Amended and Restated Certificate of Incorporation, as amended from time to time, to provide by adopting a vote or votes, a certificate of which shall be filed in accordance with the DGCL, for the issue of the Preferred Stock in one or more classes or series, each with the designations, rights and privileges that shall be stated in the vote or votes creating such classes or series. The authority of the Board of Directors of the Corporation with respect to each such class or series of Preferred Stock shall include, without limitation of the foregoing, the right to determine and fix: (a) The distinctive designation of such class or series and the number of shares to constitute such class or series; (b) The rate at which dividends on the shares of such class or series shall be declared and paid, or set aside for payment, whether dividends at the rate so determined shall be cumulative, and whether the shares of such class or series shall be entitled to any participating or other dividends in addition to dividends at the rate so determined, and if so on what terms; (c) The right, if any, of the Corporation to redeem shares of the particular class or series and, if redeemable, the price, terms and manner of such redemption; (d) The special and relative rights and preferences, if any, and the amount or amounts per share, which the shares of such class or series shall be entitled to receive upon any voluntary or involuntary liquidation, dissolution or winding up of the Corporation; (e) The terms and conditions, if any, upon shares of such class or series shall be convertible into, or exchangeable for, shares of stock, or any other class or classes, including the price or prices or the rate or rates of conversion or exchange and the terms of adjustment, if any; (f) The obligation, if any, of the Corporation to retire or purchase shares of such class or series pursuant to a sinking fund or fund of a similar nature or otherwise, and the terms and conditions of such obligation; (g) The voting rights, if any, including special voting rights with respect to the election of directors and matters adversely affecting any such class or series; 2

(h) The limitations, if any, on the issuance of additional shares of such class or series or any shares of any other class or series of Preferred Stock; and (i) Any other preferences, powers, qualifications, special or relative rights and privileges thereof that the Board of Directors of the Corporation may deem advisable and that are not inconsistent with law and the provisions of this Fourth Amended and Restated Certificate of Incorporation. ARTICLE IV The Corporation reserves the right to amend, alter, change, or repeal any provision contained in this Fourth Amended and Restated Certificate of Incorporation, in the manner now or hereafter prescribed by statute, and all rights conferred upon the stockholders herein are granted subject to this right. ARTICLE V The Corporation is to have perpetual existence. ARTICLE VI 1. The number of directors which constitutes the whole Board of Directors of the Corporation shall be designated in the Bylaws of the Corporation. Any director may be removed from office by the stockholders of the Corporation only for cause. Vacancies occurring on the Board of Directors for any reason and newly created directorships resulting from an increase in the authorized number of directors may be filled only by vote of a majority of the remaining members of the Board of Directors, although less than a quorum, or by a sole remaining director, at any meeting of the Board of Directors. A person so elected by the Board of Directors to fill a vacancy or newly created directorship shall hold office until his or her successor shall have been duly elected and qualified. 2. Elections of directors need not be by written ballot unless the Bylaws of the Corporation shall so provide. ARTICLE VII In furtherance and not in limitation of the powers conferred by statute, the Board of Directors of the Corporation is expressly authorized to make, alter, amend or repeal the Bylaws of the Corporation. ARTICLE VIII No action shall be taken by the stockholders of the Corporation except at an annual or special meeting of the stockholders called in accordance with the Bylaws and no action shall be taken by the stockholders by written consent. 3

ARTICLE IX 1. To the fullest extent permitted by the Delaware General Corporation Law as the same exists or as may hereafter be amended, a director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for a breach of fiduciary duty as a director. 2. The Corporation may indemnify to the fullest extent permitted by law any person made or threatened to be made a party to an action or proceeding, whether criminal, civil, administrative or investigative, by reason of the fact that he, his testator or intestate is or was a director, officer or employee of the Corporation or any predecessor of the Corporation or serves or served at any other enterprise as a director, officer or employee at the request of the Corporation or any predecessor to the Corporation. 3. Neither any amendment nor repeal of this Article IX, nor the adoption of any provision of this Fourth Amended and Restated Certificate of Incorporation inconsistent with this Article IX, shall eliminate or reduce the effect of this Article IX, in respect of any matter occurring, or any action or proceeding accruing or arising or that, but for this Article IX, would accrue or arise, prior to such amendment, repeal or adoption of an inconsistent provision. ARTICLE X Meetings of stockholders may be held within or without the State of Delaware, as the Bylaws may provide. The books of the Corporation may be kept (subject to any provision contained in the statutes) outside of the State of Delaware at such place or places as may be designated from time to time by the Board of Directors or in the Bylaws of the Corporation. 4

IN WITNESS WHEREOF, the undersigned has executed this Fourth Amended and Restated Certificate of Incorporation this ____ day of ________, 2005. By: -------------------- Joseph V. Gulfo, M.D. Chief Executive Officer 5

EXHIBIT 10.4 ELECTRO-OPTICAL SCIENCES, INC. 2005 STOCK INCENTIVE PLAN 1. Purpose. The purpose of the Electro-Optical Sciences, Inc. 2005 Stock Incentive Plan (the "Plan") is to establish a flexible vehicle through which Electro-Optical Sciences, Inc. (the "Company"), may offer equity-based compensation incentives to key employees and other persons (including, without limitation, directors, officers, consultants and scientific collaborators) employed or engaged by the Company and/or its subsidiaries (collectively, "Eligible Persons") to attract, motivate, reward and retain such Eligible Persons and to further align the interests of such Eligible Persons with those of the stockholders of the Company. 2. Types of Awards. Awards under the Plan may be in the form of (a) options to purchase shares of the Company's common stock, no par value per share (the "Common Stock") granted pursuant to Section 6 below, including options intended to qualify as "incentive stock options" ("ISOs") within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the "Code") and options which do not qualify as ISOs, and (b) stock awards granted pursuant to Section 7 below (collectively, "Awards"). 3. Administration. (a) Compensation Committee. The Plan shall be administered by the Compensation Committee of the Board of Directors of the Company (the "Compensation Committee"). The Compensation Committee shall be comprised of independent outside directors. (b) Authority of Compensation Committee. Subject to the limitations of the Plan, the Compensation Committee, acting in its sole and absolute discretion, shall have full power and authority to administer the Plan, including, without limitation, the power to (i) determine the eligibility and the particular persons to whom awards shall be made under the Plan, (ii) grant awards to such persons and prescribe the terms and conditions of such awards, (iii) construe, interpret and apply the provisions of the Plan and of any agreement or other instrument evidencing an award granted under the Plan, (iv) cancel, modify or waive the Company's rights with respect to, or modify, discontinue, suspend or terminate any or all outstanding Awards held by Participants, subject to any required consent under Paragraph 11, (v) prescribe, amend and rescind rules and regulations relating to the Plan, including rules governing its own operations, (vi) amend the Plan in any respect, including, without limitation, to correct any defect, supply any omission and reconcile any inconsistency in the Plan, (vii) amend any outstanding Award in any respect, including, without limitation, to accelerate the time or times at which the Award becomes vested or exercisable, (viii) carry out any responsibility or duty specifically reserved to the Compensation Committee under the Plan, and (ix) make any and all determinations and interpretations and take such other actions as may be necessary or desirable in order to carry out the provisions, intent and purposes of the Plan. All decisions of the Compensation Committee, shall be reasonable and made in good faith and shall be conclusive and binding on all Participants in the Plan.

(c) Procedures. A majority of the members of the Compensation Committee shall constitute a quorum. The Compensation Committee may act by the vote of a majority of its members present at a meeting at which there is a quorum or by unanimous written consent. Members of the Compensation Committee shall abstain from participating in and deciding matters which directly affect their individual ownership interest under the Plan. (d) Indemnification. The Company shall indemnify and hold harmless each member of the Compensation Committee and any employee or director of the Company to whom any duty or power relating to the administration or interpretation of the Plan is delegated from and against any loss, cost, liability (including any sum paid in settlement of a claim with the approval of the Board of Directors of the Company (the "Board"), damage and expense (including legal and other expenses incident thereto) arising out of or incurred in connection with the Plan, unless and except to the extent attributable to such person's fraud or willful misconduct. (e) Compliance with Code Section 162(m). In the event the Company becomes a "publicly-held corporation" as defined in Code Section 162(m)(2), the Company may establish a Compensation Committee of outside directors meeting the requirements of CoDe Section 162(m)(2) to (i) approve Awards that might reasonably be anticipated to result in the payment of employee remuneration that would otherwise exceed the limit on employee remuneration deductible for income tax purposes by the Company pursuant to Code Section 162(m); and (ii) administer the Plan. In such event, Awards under the Plan shall be granted upon satisfaction of the conditions to such grants provided pursuant to Code Section 162(m) and any Treasury Regulations promulgated thereunder. 4. Share Limitations. Subject to adjustment pursuant to Section 9 below, the maximum number of shares of Common Stock that may be issued under the Plan is 1,000,000. The number of shares authorized for issuance under this Plan and all other share amounts set forth in this Plan reflect the 1-for-2 reverse split of the Company's Common Stock authorized by the Board of Directors of the Company on May 13, 2005. In determining the number of shares that remain issuable under the Plan at any time after the date the Plan is adopted, the following shares will be deemed not to have been issued (and will be deemed to remain available for issuance) under the Plan: (i) shares remaining under an Award made under the Plan that terminates or is canceled without having been exercised or earned in full; (ii) shares subject to an award under the Plan where cash is delivered to the holder of the Award in lieu of such shares; (iii) shares of restricted stock awarded under the Plan that are forfeited in accordance with the terms of the applicable Award; and (iv) shares that are withheld in order to pay the purchase price of shares acquired upon the exercise of Awards granted under the Plan or to satisfy the tax withholding obligations associated with such exercise. The number of shares of Common Stock issued in connection with an award under the Plan will be determined net of any previously-owned shares tendered by the holder of the Award in payment of the exercise price or of applicable withholding taxes. The number of shares available for grant and issuance under the Plan shall automatically be increased on the first day of each of January 2006 and January 2007 by the lesser of: (i) three percent (3%) of the number of shares of Common Stock issued and outstanding on the preceding December 31, and (ii) a lesser number of shares of Common Stock determined by the Board of Directors of the Company. 2

5. Eligibility. Awards under the Plan may be made to any Eligible Person as the Compensation Committee may select. Each such person to whom an Award is granted under the Plan is referred to herein as a "Participant". 6. Stock Options. Subject to the provisions of the Plan, the Compensation Committee may grant options to eligible personnel upon such terms and conditions as the Compensation Committee deems appropriate. Each option granted under the Plan shall be designated as either statutory or non-statutory and each option designated as a statutory option shall be further designated as qualified or non-qualified. The terms and conditions of any option shall be evidenced by a written option agreement or other instrument approved for this purpose by the Compensation Committee ("Option Agreement"). (a) Date of Grant. Except as may be otherwise provided in an Option Agreement, the date of grant of an option under this Plan shall be the date as of which the Compensation Committee approves the grant. (b) Exercise Price. The exercise price per share of Common Stock covered by an option granted under the Plan may not be less than the Fair Market Value (as defined below) per share of the Common Stock at the time of grant (or, in the case of an ISO granted to a Participant who, at the time the option is granted, owns stock possessing more than 10% of the total combined voting power of all classes of stock of the Company or a "subsidiary" of the Company within the meaning of Section 424 of the Code, 110% of the Fair Market Value per share). (c) Option Term. No option granted under the Plan may be exercisable (if at all) more than ten years after the date the option is granted (or, in the case of an ISO granted to a ten percent stockholder described in Section 422 of the Code, five years after the date the option is granted). (d) Vesting and Exercise of Options. The Compensation Committee, in its sole discretion, may establish such vesting and other conditions and restrictions on the exercise of an option and/or upon the issuance of Common Stock in connection with the exercise of an option as it deems appropriate. Subject to satisfaction of applicable withholding requirements, once vested and exercisable, an option may be exercised by delivering a written notice (the "Notice") to the Secretary of the Company. The Notice shall state: (i) that the Participant elects to exercise the option; (ii) the number of shares with respect to which the option is being exercised (the "Option Shares"); (iii) the method of payment for the Option Shares; (iv) the date upon which the Participant desires to consummate the purchase of the Option Shares (which date must be prior to the termination of such option); and (v) any additional provisions consistent with the Plan as the Compensation Committee may from time to time require. The exercise date of an option shall be the date on which the Company receives the Notice from the Participant. The Compensation Committee, acting in its sole discretion, may permit the exercise price to be paid in whole or in part in cash or by check, by means of a cashless exercise procedure to the extent permitted by law, in the form of unrestricted shares of Common Stock (to the extent of the Fair Market Value thereof) or, subject to applicable law, by any other form of consideration deemed appropriate. (e) Rights as a Stockholder. No shares of Common Stock shall be issued in respect of the exercise of an option until full payment of the exercise price and the applicable tax withholding obligation with respect to such exercise has been made or provided for. The holder 3

of an option shall have no rights as a stockholder with respect to any shares covered by the option until the option is validly exercised, the exercise price is paid fully and applicable withholding obligations are satisfied. (f) Termination of Employment or other Service. Unless otherwise determined by the Compensation Committee at grant or, if no rights of the Participant are reduced, thereafter, and subject to earlier termination in accordance with the provisions hereof, the following rules apply with regard to options held by a Participant at the time of his or her termination of employment or other service with the Company and its subsidiaries. (i) Termination by Reason of Death or Disability. If a Participant's employment or other service terminates by reason of death or Disability (as defined below), then (1) any portion of an option held by the Participant which is not then exercisable shall thereupon terminate, and (2) any portion of an option held by the Participant which is then exercisable shall remain exercisable by the Participant (or beneficiary) for a period of one year following such termination of employment or other service or, if sooner, until the expiration of the term of the option, and, to the extent not exercised within such period, shall thereupon terminate. For purposes of the Plan, the term Disability shall mean, unless the Compensation Committee determines otherwise at the time of grant, the inability of a person to perform the essential functions of his or her position, with or without reasonable accommodation, by reason of a physical or mental incapacity or illness which is expected to result in death or to be of indefinite duration of not less than 12 months. (ii) Termination for Cause. If a Participant's employment or other service is terminated by the Company or any of its subsidiaries for Cause (as defined below), then any option held by the Participant, whether or not then exercisable, shall immediately terminate and cease to be exercisable. For purposes of the Plan, a termination for "Cause" means (1) in the case where there is no employment, consulting or similar service agreement between the Participant and the Company or any of its subsidiaries or where such an agreement exists but does not define "cause" (or words of like import), a termination classified by the Company or any of its subsidiaries, as a termination due to the Participant's (i) commission of, or entry of a plea of guilty or no contest to any felony, fraud, misappropriation, embezzlement or other crime of moral turpitude; (ii) commission of, or entry of a plea of guilty or no contest to any crime or offense involving money or property of the Company; (iii) dishonesty or fraud; or (iv) insubordination, willful misconduct, refusal to perform services or materially unsatisfactory performance of duties, or (2) in the case where there is an employment, consulting or similar service agreement between the Participant and the Company or any of its subsidiaries that defines "cause" (or words of like import), a termination that is or would be deemed for "cause" (or words of like import) under such agreement. (iii) Other Termination. If a Participant's employment or other service terminates for any reason (other than death, Disability or Cause) or no reason, then (1) any portion of an option held by the Participant which is not then exercisable shall thereupon terminate, and (2) any portion of an option held by the Participant which is then exercisable shall remain exercisable during the ninety (90) day period following such termination or, if sooner, until the expiration of the term of the option and, to the extent not exercised within such period, shall thereupon terminate. 4

(g) Nontransferability. No option shall be assignable or transferable except upon the Participant's death to a beneficiary designated by the Participant in a manner prescribed or approved for this purpose by the Compensation Committee or, if no designated beneficiary shall survive the Participant, pursuant to the Participant's will or by the laws of descent and distribution. During a Participant's lifetime, options may be exercised only by the Participant or the Participant's guardian or legal representative. Notwithstanding the foregoing, the Compensation Committee may permit the inter vivos transfer of a Participant's options (other than options designated as ISOs) by gift to such persons and on such terms and conditions as the Compensation Committee deems appropriate. 7. Stock Awards. Subject to the provisions of the Plan, the Compensation Committee may grant stock awards to eligible Participants upon such terms and conditions as the Compensation Committee deems appropriate. The terms and conditions of any stock award shall be evidenced by a written stock award agreement or other instrument approved for this purpose by the Compensation Committee. A stock award may take the form of the issuance and transfer to the recipient of shares of Common Stock or a grant of stock units representing a right to receive shares of Common Stock in the future and, in either case, may be subject to designated vesting conditions and transfer restrictions. (a) Purchase Price. The purchase price payable for shares of Common Stock transferred pursuant to a stock award must be at least equal to their Fair Market Value on the date of the grant. (b) Stock Certificates for Non-Vested Stock. Shares of Common Stock issued pursuant to a non-vested stock award may be evidenced by book entries on the Company's stock transfer records pending satisfaction of the applicable vesting conditions. If a stock certificate for shares is issued before the stock award vests, the certificate will bear an appropriate legend to reflect the nature of the conditions and restrictions applicable to the shares, and the Company may require that any or all such stock certificates be held in custody by the Company until the applicable conditions are satisfied and other restrictions lapse. The Compensation Committee may establish such other conditions as it deems appropriate in connection with the issuance of certificates for shares issued pursuant to non-vested stock awards, including, without limitation, a requirement that the recipient deliver a duly signed stock power, endorsed in blank, for the shares covered by the award. (c) Stock Certificates for Vested Stock. The recipient of a vested stock award will be entitled to receive a certificate, free and clear of conditions and restrictions (except as may be imposed in order to comply with applicable law or the terms of any stockholders' agreement), for vested shares covered by the award, subject, however, to the payment or satisfaction of withholding tax obligations in accordance with Section 10. (d) Rights as a Stockholder. Unless otherwise determined by the Compensation Committee, (i) the recipient of a stock award will be entitled to receive dividend payments, if any (or, in the case of an award of stock units, dividend equivalent payments), on or with respect to the shares that remain covered by the award (which the Compensation Committee may specify are payable on a deferred basis and are forfeitable to the same extent as the underlying award), (ii) the recipient of a non-vested stock award may exercise voting rights if and to the extent that shares of Common Stock have been issued to him pursuant to the award, and (iii) the 5

recipient will have no other rights as a stockholder with respect to such shares unless and until the shares are issued to him free of all conditions and restrictions under the Plan. (e) Termination of Employment or other Service Before Vesting; Forfeiture. Unless the Compensation Committee determines otherwise, a non-vested stock award will be forfeited upon the termination of a recipient's employment or other service with the Company and its subsidiaries. If a non-vested stock award is forfeited, any certificate representing shares subject to such award will be canceled on the books of the Company and the recipient will be entitled to receive from the Company an amount equal to any cash purchase price paid by him for such shares. If an award of stock units is forfeited, the recipient will have no further right to receive the shares of Common Stock represented by such units. (f) Nontransferability. With respect to any stock Award, unless and until all applicable vesting conditions, if any, are satisfied and vested shares are issued, neither the stock Award nor any shares of Common Stock issued pursuant to the Award may be sold, assigned, transferred, disposed of, pledged or otherwise hypothecated other than to the Company in accordance with the terms of the Award or the Plan. Any attempt to do any of the foregoing before such time shall be null and void and, unless the Compensation Committee determines otherwise, shall result in the immediate forfeiture of the shares or the Award, as the case may be. 8. Fair Market Value. For purposes of the Plan, the Fair Market Value of a share of Common Stock, as of any date shall mean, unless otherwise required by other applicable law, the closing sale price per share of Common Stock as published by the principal national securities exchange on which the Common Stock is traded on such date or, if there is no sale of Common Stock on such date, the average of the bid and asked prices on such exchange at the close of trading on such date, or if shares of the Common Stock are not listed on a national securities exchange on such date, the closing price or, if none, the average of the bid and asked prices in the over-the-counter market at the close of trading on such date, or if the Common Stock is not traded on a national securities exchange or the over-the-counter market, the Compensation Committee shall determine its Fair Market Value in such a manner as it deems appropriate (such determination will be made in good faith as required by Section 422(c)(1) of the Code, may be based on the advice of an independent investment banker or appraiser recognized to be an expert in making such valuations and will take into consideration the factors listed in 26 C.F.R.Section 20.2031.2). 9. Capital Changes; Acquisition Events. (a) Capital Changes. The maximum number and class of shares that may be issued under the Plan, the number and class of shares covered by each outstanding Award and, if applicable, the exercise price per share shall all be adjusted proportionately or as otherwise appropriate to reflect any increase or decrease in the number of issued shares of Common Stock resulting from a split-up or consolidation of shares or any like capital adjustment, or the payment of any stock dividend, and/or to reflect a change in the character or class of shares covered by the Plan arising from a readjustment or recapitalization of the Company's capital stock. (b) Acquisition Events. In the event of a merger, consolidation, mandatory share exchange or other similar business combination of the Company with or into any other entity ("Successor Entity") or any transaction in which a Successor Entity acquires all the issued and outstanding capital stock of the Company, or all or substantially all the assets of the Company 6

(each, an "Acquisition Event"), outstanding options may be assumed or an equivalent option may be substituted by the Successor Entity or a parent of the Successor Entity. If and to the extent that outstanding options are not assumed or replaced with substantially equivalent options in connection with an Acquisition Event, then each Participant shall have the right to exercise in full all of his or her outstanding options, whether or not such options are otherwise vested or exercisable, but contingent upon the occurrence of the Acquisition Event, for a period of at least twenty (20) days prior to the consummation of the Acquisition Event, in which case the Company shall notify the Participant in writing or electronically that his or her options shall become fully exercisable at least thirty (30) days prior to the consummation of the Acquisition Event, and any outstanding options which are not exercised prior to the consummation of the Acquisition Event shall thereupon terminate. Notwithstanding the preceding sentence, if and to the extent outstanding options are not assumed or replaced with substantially equivalent options in connection with an Acquisition Event, the Compensation Committee, acting in its sole discretion and without the consent of any Participant, may provide for the cancellation of any outstanding options in exchange for payment in cash or other property of the Fair Market Value of the shares of Common Stock covered by such options (whether or not otherwise vested or exercisable), reduced by the exercise price thereof (and any applicable withholdings thereon). The Compensation Committee, acting in its sole discretion, may accelerate vesting of non-vested stock awards, provide for cash settlement and/or make such other adjustments to the terms of any outstanding stock award as it deems appropriate in the context of an Acquisition Event. (c) Fractional Shares. In the event of any adjustment in the number of shares covered by any option pursuant to the provisions hereof, any fractional shares resulting from such adjustment shall be disregarded, and each such option shall cover only the number of full shares resulting from the adjustment. (d) Determinations Final. All adjustments under this Section 9 shall be made by the Compensation Committee, and its determination as to what adjustments shall be made, and the extent thereof, shall be final, binding and conclusive. 10. Tax Withholding. As a condition to the exercise of any Award or the delivery of any shares of Common Stock pursuant to any Award or the lapse of restrictions on any Award, or in connection with any other event that gives rise to a federal or other governmental tax withholding obligation on the part of the Company or any of its subsidiaries relating to an Award (including, without limitation, an income tax deferral arrangement pursuant to which employment tax is payable currently), the Company and/or the subsidiary may (a) deduct or withhold (or cause to be deducted or withheld) from any payment or distribution to an award recipient whether or not pursuant to the Plan or (b) require the recipient to remit cash (through payroll deduction or otherwise), in each case in an amount sufficient in the opinion of the Company to satisfy such withholding obligation. If the event giving rise to the withholding obligation involves a transfer of shares of Common Stock, then, at the sole discretion of the Compensation Committee, the recipient may satisfy the withholding obligation described under this Section by electing to have the Company withhold shares of Common Stock or by tendering previously-owned shares of Common Stock, in each case having a Fair Market Value equal to the amount of tax to be withheld (or by any other mechanism as may be required or appropriate to conform with local tax and other rules); provided, however, that no shares may be withheld if and to the extent that such withholding would result in the recognition of additional accounting expense by the Company. 7

11. Amendment and Termination. The Board may amend or terminate the Plan, provided, however, that no such action may adversely affect the rights of the holder of any outstanding Award in a material way without the written consent of the holder. Except as otherwise provided in Section 9, any amendment which would increase the number of shares of Common Stock which may be issued under the Plan or modify the class of persons eligible to receive Awards under the Plan shall be subject to the approval of the Company's stockholders if and to the extent that such approval is necessary or desirable to comply with applicable law or exchange or listing requirements. The Board or the Compensation Committee may amend the terms of any agreement or certificate made or issued hereunder at any time and from time to time, provided, however, that any amendment which would adversely affect the rights of the holder in a material way may not be made without his or her written consent. 12. No Rights Conferred. Nothing contained in the Plan or in any Option Agreement shall confer upon any recipient of an Award any right with respect to the continuation of his employment or other service with the Company or its subsidiaries or interfere in any way with the right of the Company and its subsidiaries at any time to terminate such employment or other service or to increase or decrease, or otherwise adjust, the other terms and conditions of the recipient's employment or other service. 13. Compliance with Law. (a) Compliance with Securities Laws. No Awards shall be granted and no shares of Common Stock shall be issued or delivered pursuant to the Plan, unless the issuance and delivery of such shares complies with applicable law, including, without limitation, the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and the requirements of any stock exchange or market upon which the Common Stock may then be listed, and shall be further subject to the approval of counsel for the Company with respect to such compliance. The Compensation Committee in its discretion may, as a condition to the delivery of any shares pursuant to any Award granted under the Plan, require the applicable Participant (i) to represent in writing that the shares received pursuant to such Award are being acquired for investment and not with a view to distribution and (ii) to make such other representations and warranties as are deemed reasonably appropriate by the Compensation Committee. Stock certificates representing shares acquired under the Plan that have not been registered under the Securities Act shall, if required by the Compensation Committee, bear such legends as may be required by the applicable Option Agreement, if any. (b) No Right to an Award or Grant. Neither the adoption of the Plan nor any action of the Compensation Committee shall be deemed to give an employee, director or consultant any right to be granted an Award to purchase Common Stock, receive an Award under the Plan except as may be evidenced by an Option Agreement duly executed on behalf of the Company, and then only to the extent of and on the terms and conditions expressly set forth in the Option Agreement. The Plan will be unfunded. The Company will not be required to establish any special or separate fund or to make any other segregation of funds or assets to assure the payment of any Award. (c) No Restriction of Corporate Action. Nothing contained in the Plan or in any Option Agreement will be construed to prevent the Company or any Subsidiary or Affiliate of 8

the Company from taking any corporate action which is deemed by the Company or by its Subsidiaries and Affiliates to be appropriate or in its best interest, whether such action would have an adverse effect on the Plan or any Award made under the Plan. No Participant or beneficiary of a Participant will have any claim against the Company or any affiliate as a result of any corporate action. 14. Transfer Orders; Placement of Legends. All certificates for shares of Common Stock delivered under the Plan shall be subject to such stock-transfer orders and other restrictions as the Company may deem advisable under the rules, regulations, and other requirements of the Securities and Exchange Commission, any stock exchange or market upon which the Common Stock may then be listed, and any applicable federal or state securities law. The Company may cause a legend or legends to be placed on any such certificates to make appropriate reference to such restrictions. 15. Decisions and Determinations to be Final. All decisions and determinations made by the Compensation Committee pursuant to the provisions hereof shall be final, binding and conclusive. 16. Governing Law. All rights and obligations under the Plan and each Option Agreement or instrument shall be governed by and construed in accordance with the laws of the State of New York, without regard to its principles of conflict of laws. 17. Term of the Plan. The Plan shall become effective on the date of its adoption by the Board, subject to the approval of the Company's stockholders within 12 months of such date. Unless sooner terminated by the Compensation Committee, the Plan shall terminate on the tenth anniversary of the date of its adoption by the Board. The rights of any person with respect to an Award granted under the Plan that is outstanding at the time of the termination of the Plan shall not be affected solely by reason of the termination of the Plan and shall continue in accordance with the terms of the Award (as then in effect or thereafter amended) and the Plan. 18. Supersession. This Plan supersedes the Electro-Optical Sciences, Inc. 2003 Stock Incentive Plan, as amended, (the "Prior Plan). Although options may be outstanding under the Prior Plan, no Awards will be granted under the Prior Plan after December 31, 2004. 19. Code Section 409A Compliance. This Plan is intended to provide for statutory and non-statutory stock option benefits that are not deemed to be deferred compensation and thus are not subject to the provisions of Code Section 409A. If the Plan is deemed to be subject to Code Section 409A, however, the Company may modify the Plan and any Awards granted under the Plan to comply with Code Section 409A guidance; provided, however, that the present value of Awards granted to Participants after such modification shall not be less than the present value of the Awards granted to Participants prior to the modification. 20. Section 16 Compliance. It is intended that the Plan and any Award made to a Participant subject to Section 16 of the Exchange Act meet all of the requirements of Rule 16b-3. If any provisions of the Plan or any Award would disqualify the Plan or the Award, or would otherwise not comply with Rule 16b-3, such provision or Award will be construed or deemed amended to conform to Rule 16b-3. 21. Related Agreements: Lock-Up. (a) As a condition to the issuance of shares of Common Stock pursuant to a stock 9

award or upon exercise of an option granted pursuant to the Plan, the recipient shall, at the request of the Board, be required to become a party to any stockholders' or similar agreement(s) to which the Company and some or all of its stockholders may from time to time be party. (b) As a condition to the issuance of shares of Common Stock pursuant to a stock award or upon exercise of an option granted pursuant to the Plan, the recipient shall, at the request of the Compensation Committee, agree that he or she will not, without the prior written consent of the managing underwriter, if any, for any public offering of the Company's securities, during the period commencing. on the date of the final prospectus relating to such public offering and ending on the date specified by the Company and the managing underwriter (such period not to exceed one hundred eighty (180) days), (i) lend, offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into or exercisable or exchangeable for Common Stock (whether such shares or any such securities are then owned by the recipient or are thereafter acquired), or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Common Stock, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Common Stock or such other securities, in cash or otherwise. In order to enforce the foregoing covenant, the Company may impose stop-transfer instructions with respect to the securities of the recipient (and the shares or securities of every other person subject to the foregoing restriction) until the end of such period. 10

EXHIBIT 10.11 CONSULTING AGREEMENT This Agreement is made as of June 1, 2005 (the "Effective Date"), between Electro-Optical Sciences, Inc, a Delaware corporation (the "COMPANY") and Gerald Wagner Consulting LLC (the "CONSULTANT"). The Consultant and the Company are parties to a certain Consulting Agreement dated as of March 17, 2005 (the "Prior Agreement.") Services rendered by the Consultant thereunder have primarily related to facilitation of the restructuring of the Company so as to enable it to make appropriate arrangements for the completion of developmental engineering of its MelaFind device. The arrangements have been effectuated with an appropriate third party, and the internal restructuring is now sufficiently along, so as to enable the parties to the Prior Agreement to revise their relationship so as to provide for the provision of services of an anticipated longer duration period. Accordingly, the parties agree as follows: 1. Services. The Field of Interest for consulting hereunder is the continued direction of the Company's MelaFind product development effort and the implementation of the manufacturing process once production of clinical trial prototypes becomes feasible. The Consultant will make himself available in person at the Company's offices or other locations as agreed upon during the term of this Agreement, as reasonably requested by the Company 2. Consideration. In consideration for the services provided by Consultant under the terms of this Agreement, Consultant shall be compensated as set forth below. 2.1 The Company will pay the Consultant an amount of one hundred fifty thousand dollars ($150,000.00), payable ratably over the course of the project at such intervals as Consultant and the Company may agree upon. This amount is considered to approximate the aggregate amount achieved by adding together $2000 for each full day to be spent on the project by Consultant. As a bonus, Consultant will be granted 50,000 non-qualified stock options to purchase Company's common stock at its then fair market value immediately after the effective date of an Initial Public Offering on Registration Statement Form S-1. The fair market value shall be deemed to be the price at which the Initial Public Offering became effective. 2.2 The parties shall assess the progress of the project at a point approximately halfway through the anticipated term. Provided that the anticipated delivery date for the first twenty-five (25) MelaFind clinical trial prototypes meeting the then-established Company specifications for such clinical trial prototypes is still during the first quarter of calendar year 2006, Consultant shall become entitled to an adjustment of the amount

paid, if necessary, so that the revised amount equals $2,000 per day for each full day actually spent and to be spent on the project by Consultant. 2.3 Reasonable expenses of the Consultant incurred at the request of the Company (including travel expenses incurred in connection with Company-related business) will be reimbursed promptly by the Company, subject to customary verification, in accordance with the Company's standard expense reimbursement and travel policy. 3. Term. The term of this Agreement will begin on the Effective Date of this Agreement and will end three months following the initiation of the pivotal clinical trial for MelaFind. The parties anticipate that the pivotal clinical trial will commence in the first quarter of 2006. The parties will negotiate over an appropriate extension of the term of this agreement starting approximately 30 days before the anticipated end of the term. 4. Certain Other Contracts. 4.1 The Consultant will not disclose to the Company any information that the Consultant is obligated to keep secret pursuant to an existing confidentiality agreement with a third party, and nothing in this Agreement will impose any obligation on the Consultant to the contrary. 4.2 The consulting work performed hereunder will not be conducted on time that is required to be devoted to any other third party. The Consultant shall not use the funding, resources and facilities of any other third party to perform consulting work hereunder and shall not perform the consulting work hereunder in any manner that would give any third party rights to the product of such work. 4.3 The Consultant has disclosed and, during the Term, will disclose to the Chief Executive Officer of the Company any conflicts between this Agreement and any other agreements binding the Consultant. 5. Exclusive Services during the Term. The Consultant agrees that during the Term of this Agreement he will not, exclusive of any research obligations to any third party, directly or indirectly (i) provide any services to any other business or commercial entity in the Field of Interest, (ii) participate in the formation of any business or commercial entity in the Field of Interest or (iii) solicit or hire away any employee or consultant of the Company. Consultant shall disclose on Exhibit A attached hereto all other consulting agreements in the Field of Interest to which Consultant is currently a party. 6. Direction of Projects and Inventions to the Company. Subject to the Consultant's obligations and confidentiality obligations to third parties, during the Term of this Agreement, the Consultant will use his best efforts to disclose to the Chief Executive Officer of the Company, on a confidential basis, technology and product opportunities which come to the attention of the Consultant in the Field of Interest, and any invention, improvement, discovery, process, formula or method or other intellectual property

relating to or useful in, the Field of Interest (collectively "New Discoveries"), whether or not patentable or copyrightable, to the extent the New Discoveries do not arise from any research undertaken by the Consultant as an employee of any third party. 7. Inventions Discovered by the Consultant While Performing Services Hereunder. 7.1 The Consultant will promptly and fully disclose to the Chief Executive Officer of the Company any invention, improvement, discovery, process, formula, technique, method, trade mark, trade secret, mask work, or other intellectual property, whether or not patentable, whether or not copyrightable (collectively, "Invention") made, conceived, developed, or first reduced to practice by the Consultant, either alone or jointly with others, while performing services hereunder. All such Inventions are work made for hire to the extent allowed by law and, in addition, Consultant hereby assigns to the Company all of his right, title and interest in and to any such Inventions. The Consultant will execute any documents necessary to perfect the assignment of such Inventions to the Company and to enable the Company to apply for, obtain, and enforce patents or copyrights in any and all countries on such Inventions. The Consultant hereby irrevocably designates the Secretary of the Company as his agent and attorney-in-fact to execute and file any such document and to do all lawful acts necessary to apply for and obtain patents and copyrights, and to enforce the Company's rights under this paragraph. This Section 7 will survive the termination of this Agreement. 7.2 If any part of the Invention is based on, incorporates, or is an improvement or derivative of, or cannot be reasonably and fully made, used, reproduced, distributed and otherwise practiced or exploited without using, infringing or violating technology or intellectual property rights owned or licensed by Consultant and not assigned hereunder, Consultant hereby grants Company a perpetual, irrevocable, worldwide royalty-free, non-exclusive, right and license, with right to sublicense, to exploit and exercise all such technology and intellectual property rights in support of Company's exercise or exploitation of the Inventions, other work performed hereunder, or any assigned rights (including any modifications, improvements and derivatives of any of them). 8. Confidentiality. 8.1 The Consultant acknowledges that, during the course of performing his services hereunder, the Company will be disclosing information to the Consultant, and the Consultant will be developing information related to the Field of Interest, Inventions, projects, products, potential customers, personnel, business plans, and finances, as well as other commercially valuable information (collectively "Confidential Information"). The Consultant acknowledges that the Company's business is extremely competitive, dependent in part upon the maintenance of secrecy, and that any disclosure of the Confidential Information would result in serious harm to the Company. 8.2 The Consultant agrees that the Confidential Information will be used by the Consultant only in connection with consulting activities hereunder, and will not be used in any way that is detrimental to the Company.

8.3 The Consultant agrees not to disclose, directly or indirectly, the Confidential Information to any third person or entity, other than representatives or agents of the Company. The Consultant will treat all such information as confidential and proprietary property of the Company. 8.4 The term "Confidential Information" does not include information that was: (i) publicly known and made generally available in the public domain prior to the time of disclosure by the disclosing party; (ii) becomes publicly known and made generally available after disclosure by the disclosing party to the receiving party through no action or inaction of the receiving party; (iii) is already in the possession of the receiving party at the time of disclosure by the disclosing party as shown by the receiving party's files and records immediately prior to the time of disclosure; (iv) is obtained by the receiving party from a third party without a breach of such third party's obligations of confidentiality; and (v) is independently developed by the receiving party without use of or reference to the disclosing party's Confidential Information, as shown by documents and other competent evidence in the receiving party's possession. 8.5 The Consultant may disclose any Confidential Information that is required to be disclosed by law, government regulation or court order. If disclosure is required, the Consultant will give the Company advance notice so that the Company may seek a protective order or take other action reasonable in light of the circumstances. 8.6 Upon termination of this Agreement, the Consultant will promptly return to the Company all materials containing Confidential Information as well as data, records, reports and other property, furnished by the Company to the Consultant or produced by the Consultant in connection with services rendered hereunder, together with all copies of any of the foregoing. Notwithstanding such return, the Consultant shall continue to be bound by the terms of the confidentiality provisions contained in this Section 8 for a period of three years after the termination of this Agreement. 9. Use of Name. It is understood that the name of the Consultant and Consultant's affiliation with any third party will appear in disclosure documents required by securities laws, and in other regulatory and administrative filings in the ordinary course of the Company's business. The above-described uses will be deemed to be noncommercial uses. The name of the Consultant or any third party will not be used for any commercial purpose without the Consultant's consent. 10. No Conflict: Valid and Binding. The Consultant represents that neither the execution of this Agreement nor the performance of the Consultant's obligations under this Agreement (as modified to the extent required by Section 4) will result in a violation or breach of any other agreement by which the Consultant is bound. The Company represents that this Agreement has been duly authorized and executed and is a valid and legally binding obligation of the Company, subject to no conflicting agreements.

11. Notices. Any notice provided under this Agreement shall be in writing and shall be deemed to have been effectively given (i) upon receipt when delivered personally, (ii) one day after sending when sent by private express mail service (such as Federal Express), or (iii) 5 days after sending when sent by regular mail to the following address: In the case of the Company: Electro-Optical Sciences, Inc One Bridge Street, Suite 15 Irvington, NY 10553 In the case of the Consultant: Name: Gerald Wagner Consulting LLC Address: 970 Route 9W Upper Grandview, NY 10960 SSN: 02-0662378 or to other such address as may have been designated by the Company or the Consultant by notice to the other given as provided herein. 12. Independent Contractor: Withholding. The Consultant will at all times be an independent contractor, and as such will not have authority to bind the Company. Consultant will not act as an agent nor shall he be deemed to be an employee of the Company for the purposes of any employee benefit program, unemployment benefits, or otherwise. The Consultant recognizes that no amount will be withheld from his compensation for payment of any federal, state, or local taxes and that the Consultant has sole responsibility to pay such taxes, if any, and file such returns as shall be required by applicable laws and regulations. Consultant shall not enter into any agreements or incur any obligations on behalf of the Company. 13. Assignment. Due to the personal nature of the services to be rendered by the Consultant, the Consultant may not assign this Agreement. The Company may assign all rights and liabilities under this Agreement to a subsidiary or an affiliate or to a successor to all or a substantial part of its business and assets without the consent of the Consultant. Subject to the foregoing, this Agreement will inure to the benefit of and be binding upon each of the heirs, assigns and successors of the respective parties. 14. Severability. If any provision of this Agreement shall be declared invalid, illegal or unenforceable, such provision shall be severed and the remaining provisions shall continue in full force and effect. 15. Remedies. The Consultant acknowledges that the Company would have no adequate remedy at law to enforce Sections 5, 7 and 8 hereof. In the event of a violation by the Consultant of such Sections, the Company shall have the right to obtain injunctive

or other similar relief, as well as any other relevant damages, without the requirement of posting bond or other similar measures. 16. Governing Law; Entire Agreement; Amendment. This Agreement shall be governed by the laws of the State of New York applicable to agreements made and to be performed within such State, represents the entire understanding of the parties. It supersedes the Prior Agreement except with respect to matters (payment for subsequent invoices, confidentiality, and the like) which by their nature should survive the termination of that agreement. It may only be amended in writing. IN WITNESS WHEREOF, this Agreement may be executed in counterparts, each of which shall constitute an original and all of which together shall constitute one instrument, effective as of the date first above written. Electro-Optical Sciences, Inc: Consultant: Gerald Wagner By: /s/ William R. Bronner Signature: /s/ Gerald Wagner Its: Vice President

EXHIBIT A OTHER RELATIONSHIPS NONE

EXHIBIT 10.12 CONSULTING AGREEMENT Agreement dated and effective as of June 20, 2003, between Electro-Optical Sciences, a Delaware corporation with its office at 1 Bridge Street, Suite 15, Irvington, New York 10533 ("EOS" or the "Company") and Breaux Castleman, with an address at , California ("Consultant"), hereinafter referred to as the "Agreement." EOS and Consultant hereby agree as follows: 1 The term of this agreement shall be two years. 2 EOS will grant Consultant a stock award by executing contemporaneously with this Agreement a Restricted Stock Purchase Agreement substantially in the form of Exhibit A hereto. the award will allow Consultant to purchase 150,000 shares of EOS common stock @ $0.23 / share, 75,000 shares of which will vest immediately, and the remaining 75,000 shares of which will vest after 1 year of service. 3 Services will be provided as the Chief Executive Officer shall direct and as Consultant shall reasonably find acceptable, within his areas of expertise. Consultant shall report to the Chief Executive Officer, with ultimate responsibility to the Board of Directors. For these services, Consultant will receive $8,000 per month, plus reasonable travel expenses. 4 Consultant is not and shall not become the agent of EOS, and has and shall have no authority, express or implied, to act as an agent of EOS or to enter into any agreement or take any action on behalf of EOS. Nothing contained herein shall constitute an employment agreement. Nothing contained herein is intended to restrict Consultant's ability to provide services to others. 5 Consultant shall continue to be obligated under the confidentiality agreement previously entered into, and Consultant shall execute the standard EOS invention disclosure agreement, a copy of which is attached as Exhibit B hereto. Termination of this agreement shall not affect Consultant's obligations under these agreements. 6 This agreement is to be governed by the substantive laws of the State of New York without regard to any provisions relating to the conflict of laws. Electro-Optical Sciences, Inc: Consultant: Breaux Castleman By: /s/ William R. Bronner Signature: /s/Breaux Castleman Its: Vice President

EXHIBIT 10.13 CONSULTING AGREEMENT This Agreement is made as of June 1, 2005 (the "Effective Date"), between Electro-Optical Sciences, Inc, a Delaware corporation (the "COMPANY") and Robert Friedman, M.D. (the "CONSULTANT"). Consultant is retiring as a voting member of the Board of Directors. Consultant is willing to continue to provide assistance to the Company. The Company wishes to retain the Consultant in a consulting capacity. Accordingly, the parties agree as follows: 1. Services. The Field of Interest for consulting includes three areas: (1) as Medical Advisor to the Board, (2) as Liaison to the Scientific and Medical Advisory Committee, and (3) in connection with the clinical testing of MelaFind(R), a melanoma diagnostic device. The Consultant will make himself available in person at the Company's offices or other locations as agreed upon during the term of this Agreement, as reasonably requested by the Company, subject to his need to satisfy other professional commitments, for up to thirty days. 2. Consideration. In consideration for the services provided by Consultant under the terms of this Agreement, Consultant shall be compensated at a rate of $5,000 per day of services rendered to the Company, or a proportionately smaller amount for less than 8 hours of services. Reasonable expenses of the Consultant incurred at the request of the Company (including travel expenses incurred in connection with Company-related business) will be reimbursed promptly by the Company, subject to customary verification, in accordance with the Company's standard expense reimbursement and travel policy. 3. Term. The term of this Agreement will begin on the Effective Date of this Agreement and will end on the one-year anniversary of this Agreement or upon earlier termination (the "Term"). The Term will be renewed for successive one-year periods, unless either party provides written notice at least thirty (30) days prior to the end of the Term that such party does not wish to renew this Agreement. 4. Exclusive Services during the Term. The Consultant agrees that during the Term of this Agreement he will not, exclusive of any research obligations to any third party, directly or indirectly (i) provide any services to any other business or commercial entity in the Field of Interest, (ii) participate in the formation of any business or commercial entity in the Field of Interest or (iii) solicit or hire away any employee or consultant of the Company. Consultant shall disclose on Exhibit A attached hereto all other consulting agreements in the Field of Interest to which Consultant is currently a party. 5. Direction of Projects and Inventions to the Company. Subject to the Consultant's obligations and confidentiality obligations to third parties, during the Term of this Agreement, the Consultant will use his best efforts to disclose to the Chief Executive Officer of the Company, on a confidential basis, technology and product opportunities

which come to the attention of the Consultant in the Field of Interest, and any invention, improvement, discovery, process, formula or method or other intellectual property relating to or useful in, the Field of Interest (collectively "New Discoveries"), whether or not patentable or copyrightable, to the extent the New Discoveries do not arise from any research undertaken by the Consultant as an employee of any third party. 6. Inventions Discovered by the Consultant While Performing Services Hereunder. 6.1 The Consultant will promptly and fully disclose to the Chief Executive Officer of the Company any invention, improvement, discovery, process, formula, technique, method, trade mark, trade secret, mask work, or other intellectual property, whether or not patentable, whether or not copyrightable (collectively, "Invention") made, conceived, developed, or first reduced to practice by the Consultant, either alone or jointly with others, while performing services hereunder. All such Inventions are work made for hire to the extent allowed by law and, in addition, Consultant hereby assigns to the Company all of his right, title and interest in and to any such Inventions. The Consultant will execute any documents necessary to perfect the assignment of such Inventions to the Company and to enable the Company to apply for, obtain, and enforce patents or copyrights in any and all countries on such Inventions. The Consultant hereby irrevocably designates the Secretary of the Company as his agent and attorney-in-fact to execute and file any such document and to do all lawful acts necessary to apply for and obtain patents and copyrights, and to enforce the Company's rights under this paragraph. This Section 7 will survive the termination of this Agreement. 6.2 If any part of the Invention is based on, incorporates, or is an improvement or derivative of, or cannot be reasonably and fully made, used, reproduced, distributed and otherwise practiced or exploited without using, infringing or violating technology or intellectual property rights owned or licensed by Consultant and not assigned hereunder, Consultant hereby grants Company a perpetual, irrevocable, worldwide royalty-free, non-exclusive, right and license, with right to sublicense, to exploit and exercise all such technology and intellectual property rights in support of Company's exercise or exploitation of the Inventions, other work performed hereunder, or any assigned rights (including any modifications, improvements and derivatives of any of them). 7. Confidentiality. 7.1 The Consultant acknowledges that, during the course of performing his services hereunder, the Company will be disclosing information to the Consultant, and the Consultant will be developing information related to the Field of Interest, Inventions, projects, products, potential customers, personnel, business plans, and finances, as well as other commercially valuable information (collectively "Confidential Information"). The Consultant acknowledges that the Company's business is extremely competitive, dependent in part upon the maintenance of secrecy, and that any disclosure of the Confidential Information would result in serious harm to the Company.

7.2 The Consultant agrees that the Confidential Information will be used by the Consultant only in connection with consulting activities hereunder, and will not be used in any way that is detrimental to the Company. 7.3 The Consultant agrees not to disclose, directly or indirectly, the Confidential Information to any third person or entity, other than representatives or agents of the Company. The Consultant will treat all such information as confidential and proprietary property of the Company. 7.4 The term "Confidential Information" does not include information that was: (i) publicly known and made generally available in the public domain prior to the time of disclosure by the disclosing party; (ii) becomes publicly known and made generally available after disclosure by the disclosing party to the receiving party through no action or inaction of the receiving party; (iii) is already in the possession of the receiving party at the time of disclosure by the disclosing party as shown by the receiving party's files and records immediately prior to the time of disclosure; (iv) is obtained by the receiving party from a third party without a breach of such third party's obligations of confidentiality; and (v) is independently developed by the receiving party without use of or reference to the disclosing party's Confidential Information, as shown by documents and other competent evidence in the receiving party's possession. 7.5 The Consultant may disclose any Confidential Information that is required to be disclosed by law, government regulation or court order. If disclosure is required, the Consultant will give the Company advance notice so that the Company may seek a protective order or take other action reasonable in light of the circumstances. 7.6 Upon termination of this Agreement, the Consultant will promptly return to the Company all materials containing Confidential Information as well as data, records, reports and other property, furnished by the Company to the Consultant or produced by the Consultant in connection with services rendered hereunder, together with all copies of any of the foregoing. Alternatively, Consultant may destroy all Confidential Information and certify to the Company that he has done so. Notwithstanding such return or destruction, the Consultant shall continue to be bound by the terms of the confidentiality provisions contained in this Section 8 for a period of three years after the termination of this Agreement. 8. Use of Name. It is understood that the name of the Consultant and Consultant's affiliation with any third party will appear in disclosure documents required by securities laws, and in other regulatory and administrative filings in the ordinary course of the Company's business. The above-described uses will be deemed to be noncommercial uses. The name of the Consultant or any third party will not be used for any commercial purpose without the Consultant's consent. 9. No Conflict: Valid and Binding. The Consultant represents that neither the execution of this Agreement nor the performance of the Consultant's obligations under this Agreement (as modified to the extent required by Section 4) will result in a violation

or breach of any other agreement by which the Consultant is bound. The Company represents that this Agreement has been duly authorized and executed and is a valid and legally binding obligation of the Company, subject to no conflicting agreements. 10. Notices. Any notice provided under this Agreement shall be in writing and shall be deemed to have been effectively given (i) upon receipt when delivered personally, (ii) one day after sending when sent by private express mail service (such as Federal Express), or (iii) 5 days after sending when sent by regular mail to the following address: In the case of the Company: Electro-Optical Sciences, Inc One Bridge Street, Suite 15 Irvington, NY 10553 In the case of the Consultant: Name: Robert Friedman, M. D. Address: 56 Old Aspetong Road Katonah, NY 10536 or to other such address as may have been designated by the Company or the Consultant by notice to the other given as provided herein. 11. Independent Contractor: Withholding. The Consultant will at all times be an independent contractor, and as such will not have authority to bind the Company. Consultant will not act as an agent nor shall he be deemed to be an employee of the Company for the purposes of any employee benefit program, unemployment benefits, or otherwise. The Consultant recognizes that no amount will be withheld from his compensation for payment of any federal, state, or local taxes and that the Consultant has sole responsibility to pay such taxes, if any, and file such returns as shall be required by applicable laws and regulations. Consultant shall not enter into any agreements or incur any obligations on behalf of the Company. 12. Assignment. Due to the personal nature of the services to be rendered by the Consultant, the Consultant may not assign this Agreement. The Company may assign all rights and liabilities under this Agreement to a subsidiary or an affiliate or to a successor to all or a substantial part of its business and assets without the consent of the Consultant. Subject to the foregoing, this Agreement will inure to the benefit of and be binding upon each of the heirs, assigns and successors of the respective parties. 13. Indemnification. The Company hereby indemnifies Contractor to the fullest extent possible against any third-party claim of any type, excluding only claims of intentional misconduct, arising with respect to any services performed hereunder.

14. If any provision of this Agreement shall be declared invalid, illegal or unenforceable, such provision shall be severed and the remaining provisions shall continue in full force and effect. 15. Remedies. The Consultant acknowledges that the Company would have no adequate remedy at law to enforce Sections 5, 7 and 8 hereof. In the event of a violation by the Consultant of such Sections, the Company shall have the right to obtain injunctive or other similar relief, as well as any other relevant damages, without the requirement of posting bond or other similar measures. 16. Governing Law; Entire Agreement; Amendment. This Agreement shall be governed by the laws of the State of New York applicable to agreements made and to be performed within such State, represents the entire understanding of the parties, supersedes all prior agreements between the parties, and may only be amended in writing. IN WITNESS WHEREOF, this Agreement may be executed in counterparts, each of which shall constitute an original and all of which together shall constitute one instrument, effective as of the date first above written. Electro-Optical Sciences, Inc: Consultant: Robert Friedman By: /s/ William R. Bronner Signature: /s/ Robert Friedman Its: Vice President

EXHIBIT A OTHER RELATIONSHIPS NONE

Exhibit 10.15 THIRD AMENDMENT TO ELECTRO-OPTICAL SCIENCES, INC. LEASE This amendment is made the 6th day of June, 2005, by and between Bridge Street Properties, LLC, a New York Limited Liability Company having an office at One Bridge Street, Irvington, New York 10533, and Electro-Optical Sciences, Inc., a Corporation having an office at One Bridge Street, Irvington, New York 10533. Witnesseth: Whereas, Owner (Bridge Street Properties, LLC) and Tenant (Electro-Optical Sciences, Inc.) entered into a lease dated December 16th, 1998 of certain premises located at One Bridge Street, Irvington, New York and Whereas, the term of the lease set forth therein is three years commencing upon, December 16, 1998 and ending upon December 15, 2001 and Now, Therefore, the parties hereto agree as follows: 1. The term set forth herein will be four years and commence July 1, 2005, and end on June 30, 2009. 2. The rate to be paid monthly/yearly will be as follows: Yearly Monthly ------ ------- 7/1/05 - 6/30/06 $100,386.00 $8,365.50 7/1/06 - 6/30/07 $103,397.58 $8,616.47 7/1/07 - 6/30/08 $106,499.51 $8,874.96 7/1/08 - 6/30/09 $109,694.49 $9,141.21 3. Clause #81, Termination Option, shall be removed. 4. New HVAC system shall be installed. The system will include 2 thermostatically controlled air dampeners. 5. A $5,100 electric upgrade to be completed as per the specifications discussed with Andy Lyons. 6. Security Deposit will increase to $17,232.94 equal to last two months rent. 7. Continuation of Lease Provisions: Except as amended herein, all other terms and conditions of the Lease shall remain in full force and effect for the duration of the Lease. /s/ William Thompson /s/ William Bronner _____________________________________ __________________________________ Bridge Street Properties, LLC Electro-Optical Science, Inc. Managing Member Vice President _____________________________________ __________________________________ Title Title 1

EXHIBIT 14.1 ELECTRO-OPTICAL SCIENCES, INC. CODE OF BUSINESS CONDUCT AND ETHICS This Code of Business Conduct and Ethics (the "Code") sets forth legal and ethical standards of conduct for directors, officers and employees of Electro-Optical Sciences, Inc. (the "Company"). This Code is intended to deter wrongdoing and to promote the conduct of all Company business in accordance with high standards of integrity and in compliance with all applicable laws and regulations. This Code applies to the Company and all of its subsidiaries (as in existence from time to time) and other business entities controlled by it worldwide. All references to employees herein shall be deemed to include officers and directors unless the context specifically only relates to employees. If you have any questions regarding this Code or its application to you in any situation, you should contact your immediate supervisor or the Company's Chief Financial Officer (the "CFO"). COMPLIANCE WITH LAWS, RULES AND REGULATIONS The Company requires that all employees comply with all laws, rules and regulations applicable to the Company wherever it does business. You are expected to use good judgment and common sense in seeking to comply with all applicable laws, rules and regulations and to ask for advice when you are uncertain about them. If you become aware of the violation of any law, rule or regulation by the Company, whether by its officers, employees, directors, or any third party doing business on behalf of the Company, it is your responsibility to promptly report the matter to your immediate supervisor or the CFO. While it is the Company's desire to address matters internally, nothing in this Code should discourage you from reporting any illegal activity, including any violation of the securities laws, antitrust laws, environmental laws or any other Federal, state or foreign law, rule or regulation, to the appropriate regulatory authority. The Company shall not discharge, demote, suspend, threaten, harass or in any other manner discriminate or retaliate against an employee because he or she reports any such violation, unless it is determined that the report was made with knowledge that it was false. This Code should not be construed to prohibit you from testifying, participating or otherwise assisting in any state or Federal administrative, judicial or legislative proceeding or investigation. CONFLICTS OF INTEREST Employees must act in the best interests of the Company. You must refrain from engaging in any activity or having a personal interest that presents a "conflict of interest." A conflict of interest occurs when your personal interest interferes, or appears to interfere, with the interests of the Company. A conflict of interest can arise whenever you, as an employee, take action or have an interest that prevents you from performing your Company duties and responsibilities honestly, objectively and effectively. No 1

employee shall use his or her position with the Company to influence a transaction with a supplier or customer in which such person has any personal interest, other than a financial interest representing less than one percent (1%) of the outstanding shares of a publicly-held company. OUTSIDE EMPLOYMENT STATEMENT Each employee agrees to devote his or her full business time, attention, skill and effort exclusively to the performance of the duties that the Company may assign. In general, outside work activities are not permitted when they: - Prevent the employee from fully performing work for which he or she is employed at the Company, including overtime assignments for non-exempt employees; - Involve performing services as a consultant, employee, officer, director, advisor or in any other capacity for, or have a financial interest in, a competitor of the Company, other than services performed at the request of the Company and other than a financial interest representing less than one percent (1%) of the outstanding shares of a publicly-held company; and - Violate provisions of applicable state or Federal law or the Company's policies or rules. REPORTING POTENTIAL CONFLICTS It is your responsibility to disclose any material transaction or relationship that reasonably could be expected to give rise to a conflict of interest to the CFO. Approval will not be given unless the relationship will not interfere with the employee's duties and will not damage the Company's reputation. INSIDER TRADING Employees who have material non-public information about the Company or other companies, including our suppliers and customers, as a result of their relationship with the Company are prohibited by law and Company policy from trading in securities of the Company or such other companies, as well as from communicating such information to others who might trade on the basis of that information. To help ensure that you do not engage in prohibited insider trading and avoid even the appearance of an improper transaction, the Company has adopted an Insider Trading Policy, which employees are required to sign at the start of their employment. If you are uncertain about the constraints on your purchase or sale of any Company securities or the securities of any other company that you are familiar with by virtue of your relationship with the Company, you should consult with the CFO before making any such purchase or sale. 2

CONFIDENTIALITY Employees must maintain the confidentiality of information entrusted to them by the Company or other companies, including our suppliers and customers, except when disclosure is authorized by a supervisor or legally mandated. Unauthorized disclosure of any confidential information is prohibited. Additionally, employees should take appropriate precautions to ensure that confidential or sensitive business information, whether it is proprietary to the Company or another company, is not communicated within the Company except to employees who have a need to know such information to perform their responsibilities for the Company. Employees (other than the Company's authorized spokespersons) must not discuss internal Company matters with, or disseminate internal Company information to, anyone outside the Company, except as required in the performance of their Company duties and after an appropriate confidentiality agreement is in place. This prohibition applies particularly to inquiries concerning the Company from the media, market professionals (such as securities analysts, institutional investors, investment advisers, brokers and dealers) and security holders. All responses to inquiries on behalf of the Company must be made only by the Company's authorized spokespersons. If you receive any inquiries of this nature, you must decline to comment and refer the inquirer to your supervisor or to one of the Company's authorized spokespersons. All employees at the start of their employment with the Company are required to sign an Employee Invention, Non-Disclosure and Non-Compete Agreement (the "Confidentiality Agreement"). Please keep in mind that the Confidentiality Agreement is binding and enforceable. Employees unsure about the confidential nature of specific information must ask their immediate supervisor or the CFO. Employees will be subject to appropriate disciplinary action, up to and including termination, for knowingly or unknowingly revealing information of a confidential nature. You also must abide by any lawful obligations that you have to your former employer. These obligations may include restrictions on the use and disclosure of confidential information, restrictions on the solicitation of former colleagues to work at the Company and non-competition obligations. ETHICAL STANDARDS The Company intends to establish and maintain an outstanding reputation for conducting its business activities. As an employee you are obligated to uphold that reputation in every business activity. Employees should endeavor to deal honestly, ethically and fairly with the Company's suppliers, customers, competitors and employees. Statements regarding the Company's products and services must not be untrue, misleading, deceptive or fraudulent. You must not take unfair advantage of anyone through manipulation, concealment, abuse of privileged information, misrepresentation of material facts or any other unfair-dealing practice. If you are ever in doubt as to whether an activity meets our 3

ethical standards or compromises the Company's reputation, please discuss it with your immediate supervisor or the CFO. PROTECTION AND PROPER USE OF CORPORATE ASSETS Employees should seek to protect the Company's assets. Theft, carelessness and waste have a direct impact on the Company's financial performance. Employees must use the Company's assets and services solely for legitimate business purposes of the Company and not for any personal benefit or the personal benefit of anyone else. Employees must advance the Company's legitimate interests when the opportunity to do so arises. You must not take for yourself personal opportunities that are discovered through your position with the Company or the use of property or information of the Company. GIFTS AND GRATUITIES The use of Company funds or assets for gifts, gratuities or other favors to employees or government officials is prohibited, except to the extent such gifts are in compliance with applicable law, nominal in amount and not given in consideration or expectation of any action by the recipient. Employees must not accept, or permit any member of his or her immediate family to accept, any gifts, gratuities or other favors from any customer, supplier or other person doing or seeking to do business with the Company, other than items of nominal value. Any gifts that are not of nominal value should be returned immediately and reported to your immediate supervisor or the CFO. If immediate return is not practical, they should be given to the Company for charitable disposition or such other disposition as the Company believes appropriate in its sole discretion. Common sense and moderation should prevail in business entertainment engaged in on behalf of the Company. Employees should provide, or accept, business entertainment to or from anyone doing business with the Company only if the entertainment is infrequent, modest and intended to serve legitimate business goals. Bribes and kickbacks are criminal acts, strictly prohibited by law. You must not offer, give, solicit or receive any form of bribe or kickback anywhere in the world. ACCURACY OF BOOKS AND RECORDS AND PUBLIC REPORTS Employees must honestly and accurately report all business transactions. You are responsible for the accuracy of your records and reports. Accurate information is essential to the Company's ability to meet legal and regulatory obligations. All Company books, records and accounts shall be maintained in accordance with all applicable regulations and standards and accurately reflect the true nature of the 4

transactions they record. The financial statements of the Company shall conform to generally accepted accounting rules and the Company's accounting policies. No undisclosed or unrecorded account or fund shall be established for any purpose. No false or misleading entries shall be made in the Company's books or records for any reason, and no disbursement of corporate funds or other corporate property shall be made without adequate supporting documentation. It is the policy of the Company to provide full, fair, accurate, timely and understandable disclosure in reports and documents filed with, or submitted to, the Securities and Exchange Commission (the "SEC") and in other public communications. CONCERNS REGARDING ACCOUNTING OR AUDITING MATTERS Employees with concerns regarding questionable accounting or auditing matters or complaints regarding accounting, internal accounting controls or auditing matters may confidentially, and anonymously if they wish, submit such concerns or complaints in writing to the CFO. See "Reporting and Compliance Procedures." All such concerns and complaints will be forwarded to the Audit Committee of the Board of Directors, unless they are determined to be without merit by the Company's Chief Executive Officer (the "CEO") and CFO of the Company. In any event, a record of all complaints and concerns received will be provided to the Audit Committee each fiscal quarter. All reports filed regarding questionable accounting or auditing matters will be automatically directed to the Chairperson of the Audit Committee. The Audit Committee will evaluate the merits of any concerns or complaints received by it and authorize such follow-up actions, if any, as it deems necessary or appropriate to address the substance of the concern or complaint. The Company will not discipline, discriminate against or retaliate against any employee who reports a complaint or concern, unless it is determined that the report was made with knowledge that it was false. DEALINGS WITH INDEPENDENT AUDITORS No employee, officer or director shall, directly or indirectly, make or cause to be made a materially false or misleading statement to an accountant in connection with (or omit to state, or cause another person to omit to state, any material fact necessary in order to make statements made, in light of the circumstances under which such statements were made, not misleading to, an accountant in connection with) any audit, review or examination of the Company's financial statements or the preparation or filing of any document or report with the SEC. No employee, officer or director shall, directly or indirectly, take any action to coerce, manipulate, mislead or fraudulently influence any independent public or certified public accountant engaged in the performance of an audit or review of the Company's financial statements. 5

WAIVERS OF THIS CODE OF BUSINESS CONDUCT AND ETHICS While some of the policies contained in this Code must be strictly adhered to and no exceptions can be allowed, in other cases exceptions may be possible. Any employee who believes that an exception to any of these policies is appropriate in his or her case should first contact his or her immediate supervisor. If the supervisor agrees that an exception is appropriate, the approval of the CFO must be obtained. The CFO shall be responsible for maintaining a complete record of all requests for exceptions to any of these policies and the disposition of such requests. REPORTING AND COMPLIANCE PROCEDURES Every employee has the responsibility to ask questions, seek guidance, report suspected violations and express concerns regarding compliance with this Code. Any employee who knows or believes that any other employee or representative of the Company has engaged or is engaging in Company-related conduct that violates applicable law or this Code should report such information to his or her immediate supervisor or to the CFO, as described below. You may report such conduct openly or anonymously without fear of retaliation. The Company will not discipline, discriminate against or retaliate against any employee who reports such conduct, unless it is determined that the report was made with knowledge that it was false, or who cooperates in any investigation or inquiry regarding such conduct. Any supervisor who receives a report of a violation of this Code must immediately inform the CFO. You may report violations of this Code, on a confidential or anonymous basis, by contacting the CFO or Audit Committee Chairperson by fax, mail or e-mail. While we prefer that you identify yourself when reporting violations so that we may follow up with you, as necessary, for additional information, you may do so anonymously if you wish. Once information regarding an alleged violation of this Code has been received, the receiver of such information, the CFO or Audit Committee Chairperson) shall, as appropriate, (a) evaluate such information, (b) if the alleged violation involves an executive officer or a director, inform the CEO and Board of Directors of the alleged violation, (c) determine whether it is necessary to conduct an informal inquiry or a formal investigation and, if so, initiate such inquiry or investigation, and (d) report the results of any such inquiry or investigation, together with a recommendation as to disposition of the matter, to the CEO for action, or if the alleged violation involves an executive officer or a director, report the results of any such inquiry or investigation to the Board of Directors or a committee thereof. Employees are expected to cooperate fully with any inquiry or investigation by the Company regarding an alleged violation of this Code. Failure to cooperate with any such inquiry or investigation may result in disciplinary action, up to and including discharge. The Company shall determine whether violations of this Code have occurred and, if so, shall determine the disciplinary measures to be taken against any employee who has violated this Code. In the event that the alleged violation involves an executive officer or 6

a director, the CEO and the Board of Directors, respectively, shall determine whether a violation of this Code has occurred and, if so, shall determine the disciplinary measures to be taken against such executive officer or director. Failure to comply with the standards outlined in this Code will result in disciplinary action, up to and including termination. Certain violations of this Code may require the Company to refer the matter to the appropriate governmental or regulatory authorities for investigation or prosecution. Moreover, any supervisor who directs or approves of any conduct in violation of this Code, or who has knowledge of such conduct and does not immediately report it, also will be subject to disciplinary action, up to and including termination. DISSEMINATION AND AMENDMENT This Code shall be distributed to each new employee, officer and director of the Company upon commencement of his or her employment or other relationship with the Company and shall also be distributed annually to each employee, officer and director of the Company, and each employee, officer and director shall certify that he or she has received, read and understood the Code and has complied with its terms. The Company reserves the right to amend, alter or terminate this Code at any time for any reason. Adopted by the Board of Directors of Electro-Optical Sciences, Inc. on May 13, 2005 7

Exhibit 23.1 The following consent is in the form that will be signed upon the effectiveness of the one-for-two reverse common stock split described in Note 1 to the financial statements. /s/ Eisner LLP New York, New York July 15, 2005 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the reference to our firm under the caption "Experts" and to the use of our report dated May 31, 2005 in the Registration Statement on Form S-1 (No.333-125517) and related Prospectus of Electro-Optical Sciences, Inc. Eisner LLP New York, New York