FORM S-3
As filed with the Securities and Exchange Commission on June 26, 2008
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER SECURITIES ACT OF 1933
ELECTRO-OPTICAL SCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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13-3986004 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
3 West Main Street, Suite 201
Irvington, New York 10533
(914) 591-3783
(Address, including zip code, and telephone number, including
area code, of Registrants principal executive offices)
Joseph V. Gulfo, M.D., M.B.A.
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)
Copy To:
Valerie A. Price, Esq.
Dreier LLP
499 Park Avenue
New York, New York 10022
(212) 328-6100
Approximate date of commencement of proposed sale to the public: From time to time after the
effective date of this registration statement.
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
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, other than securities offered only in
connection with dividend or interest reinvestment plans, check the
following box. þ
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, please 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 registration statement pursuant to general Instruction I.D. or a post-effective
amendment thereto that shall become effective upon filing with the commission pursuant to Rule
462(e) under the Securities Act, check the following box, o
If this Form is a post-effective amendment to a registration statement filed pursuant to General
Instruction I.D. filed to register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the following box. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer þ |
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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Smaller Reporting Company o |
CALCULATION OF REGISTRATION FEE
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Title of each class of |
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Amount to be |
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Proposed maximum aggregate |
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Amount of |
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securities to be registered (1) |
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registered (1) |
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offering price per unit (2) |
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registration fee (3) |
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Common Stock, par value $0.001
per share |
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Warrants |
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Units |
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Total |
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$40,000,000 |
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$1,572 |
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(1) |
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There are being registered hereunder such indeterminate number of shares of common stock,
such indeterminate number of warrants to purchase common stock and such indeterminate number
of units as shall have an aggregate initial offering price not to exceed $40,000,000. Any
securities registered hereunder may be sold separately or as units with other securities
registered hereunder. The securities registered also include such indeterminate number of
shares of common stock as may be issued upon the exercise of warrants or pursuant to the
antidilution provisions of any such securities. In addition, pursuant to Rule 416 under the
Securities Act of 1933, as amended (the Securities Act), the securities being registered
hereunder include such indeterminate number of shares of common stock as may be issuable with
respect to the shares being registered hereunder as a result of stock splits, stock dividends
or similar transactions. |
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The proposed maximum aggregate offering price per class of security will be determined from
time to time by the Registrant in connection with the issuance by the Registrant of securities
registered hereunder and is not specified as to each class of security pursuant to General
II.D. of Form S-3 under the Securities Act. |
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(3) |
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Calculated 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 jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED, JUNE 26, 2008
PRELIMINARY PROSPECTUS
$40,000,000
ELECTRO-OPTICAL SCIENCES, INC.
Common Stock, Warrants and Units
We may from time to time sell any combination of securities described in this prospectus,
either individually or in units. The aggregate initial offering price of all securities sold by us
under this prospectus will not exceed $40,000,000.
This prospectus provides a general description of the securities we may offer. Each time we
sell securities, we will provide the specific terms of the securities offered in a supplement to
this prospectus. The prospectus supplement may also add, update or change information contained in
this prospectus. You should read this prospectus and the applicable prospectus supplement
carefully before you invest in any securities. This prospectus may not be used to consummate a
sale of securities unless accompanied by the applicable prospectus supplement.
Our common stock is listed on the Nasdaq Capital Market under the symbol MELA. On June 25,
2008, the last reported sale price of our common stock, as reported on the Nasdaq Capital Market,
was $7.78 per share. The applicable prospectus supplement will contain information, where
applicable, as to any other listing on the Nasdaq Capital Market or any securities market or other
exchange of the securities, if any, covered by the prospectus supplement. If any agents or
underwriters are involved in the sale of any of these securities, the applicable prospectus
supplement will provide the names of the agents or underwriters and any applicable fees,
commissions or discounts.
INVESTING IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. SEE RISK FACTORS BEGINNING ON PAGE
3, AS WELL AS THE RISKS DISCUSSED UNDER THE CAPTION RISK FACTORS IN DOCUMENTS WE SUBSEQUENTLY
FILE WITH THE SECURITIES AND EXCHANGE COMMISSION.
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.
The date of this prospectus is , 2008
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
In this prospectus, unless we indicate otherwise, we, us,, our and EOS refer to
Electro-Optical Sciences, Inc.
This prospectus is a part of a registration statement that we filed with the Securities and
Exchange Commission, or SEC, utilizing a shelf registration process. Under this shelf
registration process, we may sell any combination of the securities described in this prospectus in
one or more offerings up to a total dollar amount of $40,000,000. This prospectus provides you with
a general description of the securities we may offer. Each time we sell securities under this
shelf registration, we will provide a prospectus supplement that will contain specific information
about the terms of that offering. The prospectus supplement may also add, update or change
information contained in this prospectus. You should read both this prospectus and any prospectus
supplement together with additional information described under the heading Where You Can Find
More Information.
We have not authorized any dealer, salesman or other person to give any information or to make
any representation other than those contained or incorporated by reference in this prospectus and
the accompanying supplement to this prospectus. You must not rely upon any information or
representation not contained or incorporated by reference in this prospectus or the accompanying
prospectus supplement. This prospectus and the accompanying supplement to this prospectus do not
constitute an offer to sell or the solicitation of an offer to buy any securities other than the
registered securities to which they relate, nor do this prospectus and the accompanying supplement
to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in
any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such
jurisdiction. You should not assume that the information contained in this prospectus and the
accompanying prospectus supplement is accurate on any date subsequent to the date set forth on the
front of the document or that any information we have incorporated by reference is correct on any
date subsequent to the date of the document incorporated by reference, even though this prospectus
and any accompanying prospectus supplement is delivered or securities sold on a later date.
We were incorporated in 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.
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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.
COMPANY 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 sophisticated algorithms in
order to provide information to the physician and produce a recommendation of whether the lesion
should be biopsied.
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 contained in this prospectus and in
documents that are incorporated by reference into this prospectus. 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 six 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:
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we may not be able to obtain regulatory approvals for MelaFind®, or the
approved indication may be narrower than we seek; |
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MelaFind® may not prove to be safe and effective in clinical trials; |
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physicians may not receive any reimbursement from third-party payers, or the level of
reimbursement may be insufficient to support widespread adoption of MelaFind®; |
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we may experience delays in our development program; |
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any products that are approved may not be accepted in the marketplace by physicians or
patients; |
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we may not have adequate financial or other resources to complete the development or to
commence the commercialization of MelaFind® and we will not have adequate
financial or other resources to achieve significant commercialization of
MelaFind®; |
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we may not be able to manufacture our products in commercial quantities or at an
acceptable cost; and |
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rapid technological change may make our technology and products obsolete. |
We do not expect to be able to commercialize MelaFind® before the first half of
2009. If we are unable to develop, obtain regulatory approval for or successfully commercialize
MelaFind®, we will be unable to generate revenue.
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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 pre-market approval (PMA) from the
Food and Drug Administration (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 FDAs 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:
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MelaFind® may not be safe or effective to the FDAs satisfaction; |
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the data from our pre-clinical studies and clinical trials may be insufficient to
support approval; |
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the manufacturing process or facilities we use may not meet applicable requirements;
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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, 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 trials 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. On October
12, 2006 we announced that the FDA had informed us that when submitted the MelaFind® PMA
application would receive expedited review. Expedited review means that upon filing a PMA
application with the FDA, it is placed at the beginning of the FDAs review queue and receives
additional review resources. While the expedited review could shorten the MelaFind® FDA
approval process, we can give no assurances that this will be the case. On June 11, 2008, we
announced that 1,100 patients have been accrued, in the MelaFind® pivotal trial
including more than 100 melanomas, over 85 of which are eligible and evaluable for primary endpoint
analyses. Accrual in the pivotal trial will be complete when 93 eligible and evaluable melanomas
are confirmed, which is anticipated within several weeks. We also announced that if the pivotal
trial proceeds as anticipated we plan to file the PMA application in the fourth quarter of 2008.
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 assisting in the diagnosis of 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 may 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.
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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.
MelaFind® may not be commercially viable if we fail to obtain an adequate level of
reimbursement by Medicare and other third party payers. 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 payers.
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 payers 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 payers
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 payers 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 the Centers for Medicare and
Medicaid Services (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 statutory provisions intended to facilitate coverage determinations for
new technologies, but it is unclear how these 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.
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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, we have a Protocol Agreement
with the FDA, and in late January 2007 we commenced 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 have the hardware systems necessary to fully implement our pivotal clinical trial
that started in late January 2007. However, the pivotal clinical trial and supporting clinical
studies require the involvement of a number of clinical sites 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 is required to be completed before the classifier is
utilized as described above. Accordingly, the classifier must be ready for final training when the
data from the pivotal trial become available. To date, there are over 400 melanoma lesions in the
training database. The current classifier has been trained on 221 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 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 have been 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 the sale of our equity securities and have devoted substantially all of our resources to
research and development relating to MelaFind®. Our net loss for the three months ended
March 31, 2008 was approximately $4.3 million, and as of March 31, 2008, we had an accumulated
deficit of approximately $47.4 million. Our research and development expenses may continue 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, which will require additional funding, and
manufacturing expenses. Additionally, our general and administrative expenses have also increased
due to the additional operational and regulatory responsibilities applicable to public companies.
As a result, we expect to continue to incur significant and increasing operating losses for the
foreseeable future. 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.; Biomips Engineering and SciBase AB. 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.
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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:
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significantly greater name recognition; |
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established relations with healthcare professionals, customers and third-party payers; |
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established distribution networks; |
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additional lines of products, and the ability to offer rebates, higher discounts or
incentives to gain a competitive advantage; |
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greater experience in conducting research and development, manufacturing, clinical
trials, obtaining regulatory approval for products, and marketing approved products; and |
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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, including molecular imaging in which tagged antibodies search for cancer cell
antigens, and molecular and genetic screening tests. Molecular-based approaches are being
investigated; Dermtech is exploring Messenger RNA analysis of surface cells, for example. 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 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®.
7
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:
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the FDA, an Institutional Review Board (IRB) or other regulatory authorities place our
clinical trial on hold; |
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patients do not enroll in clinical trials at the rate we expect; |
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patient follow-up is not at the rate we expect; |
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IRBs and third-party clinical investigators delay or reject our trial protocol; |
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third-party organizations do not perform data collection and analysis in a timely or
accurate manner; |
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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; |
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changes in governmental regulations or administrative actions; and |
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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 payers to reduce or limit the growth of healthcare costs,
the increasing influence of health maintenance organizations, and additional legislative proposals
to reduce or limit increases in public funding for healthcare services. Private payers, including
managed care payers, 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 payers are
expected to continue. Payers 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.
8
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 payers, 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:
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perceived effectiveness of MelaFind®; |
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convenience of use; |
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cost of use of MelaFind®; |
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availability and adequacy of third-party coverage or reimbursement; |
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approved indications and product labeling; |
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publicity concerning MelaFind® or competitive products; |
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potential advantages over alternative diagnostic methodologies; |
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introduction and acceptance of competing products or technologies; and |
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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®; however, 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 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 commence commercialization of MelaFind®
or other products without additional funding and we will not be able to achieve significant
commercialization without additional funding.
As of March 31, 2008, we had $15.9 million in cash and cash equivalents and $1.3 million in
marketable securities. Our operations have consumed substantial amounts of cash for each of the
last eight years. We currently believe that our available cash and cash equivalents, including the
proceeds from our November 2006 and August 2007 financings and our 2005 initial public offering,
will be sufficient to fund our anticipated levels of operations into second quarter 2009. If
development events do not unfold as anticipated, we will take the necessary action to reduce the
cash consumed by us in order to proceed to FDA PMA filing. However, our business or operations may
change in a manner that would consume available resources more rapidly than we anticipate. We
expect to continue to spend substantial amounts on research and development, including conducting
the pivotal clinical trial for MelaFind®. We will need additional funds to fully
commercialize the product, 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 of MelaFind® and commence
commercialization of MelaFind®, and we will need additional funds to achieve significant
commercialization of MelaFind®.
9
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:
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the schedule, costs, and results of our clinical trials; |
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the success of our research and development efforts; |
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the costs and timing of regulatory approval; |
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reimbursement amounts for the use of MelaFind® that we are able to obtain
from Medicare and third-party payers, or the amount of direct payments we are able to
obtain from patients and/or physicians utilizing MelaFind®; |
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the cost of commercialization activities, including product marketing and building a
domestic direct sales force; |
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the emergence of competing or complementary technological developments; |
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the costs of filing, prosecuting, defending and enforcing any patent claims and other
rights, including litigation costs and the results of such litigation; |
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the costs involved in defending any patent infringement actions brought against us by
third parties; and |
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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 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. We anticipate that we
will need additional funds in order to fully implement this marketing plan. In addition to being
expensive, developing such a sales force is 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.
10
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 third-party manufacturing capacity. 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 production 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, when we enter into contracts for the 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 manufacturers with whom we
have developed or 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, when 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 Carl Zeiss Jena GmbH (Zeiss) for lens and lens objective assemblies, on
ASKION GmbH (Askion) for the main subassembly and on Fairchild Semiconductor Corp., Panasonic
Corp., Roithner-Laser Vienna, CompServ and others for light-emitting diodes, or LEDs, printed
circuit boards, and other elements or components of our devices. We have several vendors to perform
additional services or produce components for us. There can be no assurance that these third
parties will meet their obligations. 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 procure their raw material on time, 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:
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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; |
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we may not be able to obtain adequate supply in a timely manner or on commercially
reasonable terms; |
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we may have difficulty locating and qualifying alternative suppliers for our
sole-source suppliers; |
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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; |
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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 |
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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. |
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 to complete developmental engineering
and testing of our hand-held imaging device, and have also entered into a production agreement with
ASKION to assemble the components and produce initial quantities of our hand-held imaging devices.
We intend to enter into a contract for commercial production of the hand-held imaging devices once
commercial 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. Similarly, we have entered into a confidentiality agreement and a development agreement
with Zeiss for lenses and lens objective assemblies, and we have entered into a contract for the
commercial production of lenses. The manufacturing agreement with ASKION will include integration
of the Zeiss lenses in the hand-held imaging devices. 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,
including confidentiality obligations in the case of Zeiss, which is an affiliate of Carl Zeiss AG,
a potential competitor. 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 the first half of 2009. 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 FDA Quality System
Regulation (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.
12
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 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. The FDA inspectors observed deficiencies that were
documented on FDA Form 483 that was issued to us following the inspection. The DIFOTI®
inspectional findings were discussed in a subsequent meeting with the FDA on April 28, 2005. An
onsite consultant was hired to address these deficiencies and structure a compliant Quality System
for MelaFind®. Throughout 2006 we worked to address the deficiencies noted in accordance
with the agreement reached with the FDA. On May 18, 2006, the FDA re-audited the Companys facility
for a follow-up inspection and audited our revised Quality System. No non-conformities or negative
observations were reported to the Company. On December 5, 2006 we received correspondence from the
FDA that reported that all previous observations reported on the FDA-483 were corrected, and this
firm no longer manufactures or distributes the DIFOTI® 2.0 dental imaging system. A
second follow-up inspection was conducted in May 2008; no deficiencies were cited by the FDA field
inspector.
We continue to work with both our in-house consultant and our full-time director of quality
assurance and regulatory affairs to address the inspectional findings, particularly as they relate
to current MelaFind® design development and ultimately MelaFind® commercial
manufacturing. If we are not successful in convincing the FDA that we are capable of addressing any
concerns it might have relative to MelaFind®, or in our efforts to address any
MelaFind® deficiencies that might develop, we could 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:
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warning letters; |
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fines and civil penalties; |
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unanticipated expenditures; |
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delays in approving or refusal to approve MelaFind®; |
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withdrawal of approval by the FDA or other regulatory bodies; |
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product recall or seizure; |
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interruption of production; |
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operating restrictions; |
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injunctions; and |
13
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, 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, 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:
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billing for services; |
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quality of medical equipment and services; |
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confidentiality, maintenance and security issues associated with medical records and
individually identifiable health information; |
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false claims; and |
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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
managements 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
14
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 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. Certain 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 managements 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 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.
15
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. Consequently, the trials are conducted under the
auspices of an abbreviated Investigational Device Exemption. 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.
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 could adversely impact our business, financial condition and results of operations. While the Company does provide off-site back-up for its
critical data which we believe to be sufficient to meet our needs, there can be no assurance that
the our current plan can anticipate every possible eventuality.
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We may be adversely affected by breaches of online security.
Our MelaFind® lesion 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 regulatory, quality assurance and 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.
If there is a connection between the MelaFind® hand-held imaging device and the
central server in our offices, it will be dependent on the internet. We may use the internet as a
medium to provide quality control calibration 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 may be 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®.
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.
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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., MBA, our
President and Chief Executive Officer and Dina Gutkowicz-Krusin, Ph.D., our Director of Clinical
Research. 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 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 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 fair value of the options. We have also
granted options that vest upon attainment of development milestones. Upon the attainment of each of
the relevant development milestones there could be a significant compensation charge based on the
then fair value of such options.
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 could have
an adverse effect on our stock price.
The Sarbanes-Oxley Act of 2002 (SOX), as well as rules subsequently implemented by the SEC,
the Public Company Accounting Oversight Board and the NASDAQ Capital Market, have required changes
in the corporate governance practices of public companies. Monitoring compliance with the existing
rules and implementing changes required by new rules may increase our legal and financial
compliance costs, divert management attention from operations and strategic opportunities, and make
legal, accounting and administrative activities more time-consuming and costly. On June 30, 2007,
our market capitalization exceeded $75 million. As a result we had our independent registered
public accounting firm attest to our compliance with Section 404 of SOX as of December 31, 2007. In
2007, we retained a consultant experienced in SOX that assisted us in the process of instituting
changes to our internal procedures to satisfy the requirements of the SOX. We have evaluated our
internal control
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. As a small company
with limited capital and human resources, going forward we may need to divert managements time and
attention away from our business in order to ensure continued compliance with these regulatory
requirements. We may require new information technologies systems, the auditing of our internal controls, and compliance training for our directors, officers and personnel. Such efforts may entail a 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 ensure that we can conclude on an ongoing basis that we have effective internal control
over financial reporting in accordance with Section 404 of the SOX. Any failure to maintain the
adequacy of our internal controls could have an adverse effect on timely and accurate financial
reporting and the trading price of our common stock.
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Risks Relating to our Common Stock
An active trading market for our common stock may not be sustained.
An active public market for our common stock may not be sustained. Further, we cannot be
certain that the market price of our common stock will not decline below the amount required by
NASDAQ to maintain a listing on its Capital Market. Should we fail to meet the minimum standards
established by NASDAQ for its Capital Market, we could be de-listed, meaning shareholders might be
subject to limited liquidity.
Our stock price is likely to be volatile, meaning purchasers of our common stock could incur
substantial losses.
Our stock price is likely to be volatile. Between October 28, 2005 (the date of our initial
public offering) and May 31, 2008, our stock price has ranged from $3.84 to $9.30 per share. 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. 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:
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results of our research and development efforts and our clinical trials; |
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the timing of regulatory approval for our products; |
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failure of any of our products, if approved, to achieve commercial success; |
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the announcement of new products or product enhancements by us or our competitors; |
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regulatory developments in the US and foreign countries; |
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ability to manufacture our products to commercial standards; |
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developments concerning our clinical collaborators, suppliers or marketing partners; |
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changes in financial estimates or recommendations by securities analysts; |
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public concern over our products; |
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developments or disputes concerning patents or other intellectual property rights; |
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product liability claims and litigation against us or our competitors; |
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the departure of key personnel; |
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the strength of our balance sheet; |
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variations in our financial results or those of companies that are perceived to be
similar to us; |
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changes in the structure of and third-party reimbursement in the US and other
countries; |
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changes in accounting principles or practices; |
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general economic, industry and market conditions; and |
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future sales of our common stock. |
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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, if brought, may not be adequate.
If our directors, executive officers, and principal stockholders choose to act together, they may
have the ability to influence all matters submitted to stockholders for approval.
As of May 31, 2008, our directors, executive officers, holders of more than 5% of our common
stock, and their affiliates in the aggregate, beneficially owned approximately 42.3% of our
outstanding common stock. As a result, these stockholders, subject to any fiduciary duties owed to
our other stockholders under Delaware law, could 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.
Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable
and could also limit the market price of our stock.
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:
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set limitations on the removal of directors; |
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limit who may call a special meeting of stockholders; |
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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; |
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do not permit cumulative voting in the election of our directors, which would otherwise
permit less than a majority of stockholders to elect directors; |
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prohibit stockholder action by written consent, thereby requiring all stockholder
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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 acquirers at a premium over prevailing prices.
This potential inability to obtain a control premium could reduce the price of our common stock.
20
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
The statements contained or incorporated by reference in this prospectus that are not
historical facts are forward-looking. These statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Such statements include,
without limitation, our expectations regarding sales, earnings or other future financial
performance and liquidity, conduct and completion of clinical trials, product introductions, entry
into new geographic regions, and general optimism about future operations or operating results.
Some of these statements can be identified by the use of forward-looking terminology such as
prospects, outlook, believes, estimates, intends, may, will, should, anticipates,
expects or plans, or the negative or other variation of these or similar words, or by
discussion of trends and conditions, strategy or risks and uncertainties.
These forward-looking expectations are based on current assumptions within the bounds of
managements knowledge of our business and operations and which management believes are reasonable.
These assumptions are subject to risks and uncertainties, and actual results could differ
materially from expectations because of issues and uncertainties such as those listed under the
caption Risk Factors and elsewhere in this prospectus and in documents incorporated into this
prospectus which, among others, should be considered in evaluating our future financial
performance. All subsequent written and oral forward-looking statements attributable to us or
persons acting on our behalf are expressly qualified in their entirety by the cautionary statements
in this prospectus. Readers are advised to consult any further disclosures we may make on related
subjects in subsequent reports filed with the SEC.
Additional information on factors that may affect our business and financial results can be
found in our filings with the SEC. All forward-looking statements should be considered in light of
these risks and uncertainties. We assume no responsibility to update forward-looking statements
made in this prospectus.
USE OF PROCEEDS
Unless otherwise provided in the applicable prospectus supplement, we intend to use the net
proceeds from the sale of the securities under this prospectus for general corporate purposes,
which may include, among other things, working capital, acquisition or investments in our
businesses and capital expenditures. Pending the application of the net proceeds, we intend to
invest the net proceeds in short-term, investment grade, interest-bearing securities.
PLAN OF DISTRIBUTION
Unless otherwise set forth in a prospectus supplement accompanying this prospectus, we may
sell the offered securities in any one or more of the following ways from time to time:
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through agents; |
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to or through underwriters; |
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through dealers; |
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directly to purchasers; or |
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through remarketing firms. |
The prospectus supplement with respect to the offered securities will set forth the terms of
the offering of the offered securities, including:
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the name or names of any underwriters, dealers or agents; |
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the purchase price of the offered securities and the proceeds to us from such
sale; |
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any underwriting discounts and commissions or agency fees and other items
constituting underwriters or agents compensation; |
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any initial public offering price and any discounts or concessions allowed or
reallowed or paid to dealers; and |
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any securities exchange on which such offered securities may be listed. |
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Any initial public offering price, discounts or concessions allowed or reallowed or paid to
dealers may be changed from time to time.
The distribution of the offered securities may be effected from time to time in one or more
transactions at a fixed price or prices, which may be changed, at market prices prevailing at the
time of sale, at prices related to such prevailing market prices or at negotiated prices.
Offers to purchase the offered securities may be solicited by agents designated by us from
time to time. Any agent involved in the offer or sale of the offered securities will be named, and
any commissions payable by us to such agent will be set forth, in the applicable prospectus
supplement. Unless otherwise indicated in the prospectus supplement, the agent will be acting on a
reasonable best efforts basis for the period of its appointment.
If underwriters are used in the sale of the offered securities, the offered securities will be
acquired by the underwriters for their own account and may be resold from time to time in one or
more transactions, including negotiated transactions, at fixed public offering prices or at varying
prices determined by the underwriters at the time of sale. The offered securities may be offered to
the public either through underwriting syndicates represented by managing underwriters or directly
by the managing underwriters. Unless otherwise indicated in the applicable prospectus supplement,
the underwriters are subject to certain conditions precedent and will be obligated to purchase all
the offered securities of a series if they purchase any of the offered securities.
If a dealer is used in the sale of the offered securities, we will sell the offered securities
to the dealer as principal. The dealer may then resell the offered securities to the public at
varying prices to be determined by the dealer at the time of resale. The name of the dealer and the
terms of the transaction will be set forth in the applicable prospectus supplement.
Offers to purchase the offered securities may be solicited directly by us and the sale thereof
may be made by us directly to institutional investors or others. The terms of any such sales will
be described in the applicable prospectus supplement.
The offered securities may also be offered and sold by a remarketing firm in connection with a
remarketing arrangement upon their purchase. Remarketing firms will act as principals for their own
accounts or as agents for us. These remarketing firms will offer or sell the offered securities
pursuant to the terms of the offered securities. Any remarketing firm will be identified and the
terms of its agreements, if any, with us and its compensation will be described in the applicable
prospectus supplement.
We may authorize underwriters, dealers and agents to solicit from third parties offers to
purchase the offered securities under contracts providing for payment and delivery on future dates.
The applicable prospectus supplement will describe the material terms of these contracts, including
any conditions to the purchasers obligations, and will include any required information about
commissions we may pay for soliciting these contracts.
In connection with the sale of the offered securities, agents, underwriters, dealers or
remarketing firms may receive compensation from us or from purchasers of the offered securities for
whom they act as agents in the form of discounts, concessions or commissions. Underwriters may sell
the offered securities to or through dealers, and those dealers may receive compensation in the
form of discounts, concessions or commissions from the underwriters or commissions from the
purchasers for whom they may act as agents. Agents, underwriters, dealers and remarketing firms
that participate in the distribution of the offered securities, and any institutional investors or
others that purchase offered securities directly and then resell the securities, may be deemed to
be underwriters, and any discounts or commissions received by them from us and any profit on the
resale of the securities by them may be deemed to be underwriting discounts and commissions under
the Securities Act.
The maximum commission or discount to be received by any member of the Financial Industry
Regulatory Authority (FINRA) or independent broker-dealer will not be greater than 8% of the
initial gross proceeds received by us for the sale of any securities being registered pursuant to
SEC Rule 415.
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Agents, underwriters, dealers and remarketing firms may be entitled under relevant agreements
entered into with us to indemnification by us against certain civil liabilities, including
liabilities under the Securities Act or to contribution with respect to payments which the agents,
underwriters or dealers may be required to make.
Each series of the offered securities will be a new issue and, other than the shares of common
stock which are listed on the Nasdaq Capital Market, will have no established trading market. Any
underwriters to whom we sell the offered securities for public offering and sale may make a market
in the securities, but such underwriters will not be obligated to do so and may discontinue any
market making at any time without notice. We may elect to list any series of offered securities on
an exchange, and in the case of common stock, on any additional exchange, but, unless otherwise
specified in the applicable prospectus supplement, we will not be obligated to do so. We cannot
predict the liquidity of the trading market for any of the offered securities.
In connection with an offering, the underwriters may purchase and sell the offered securities
in the open market. These transactions may include short sales, stabilizing transactions and
purchases to cover positions created by short sales. Short sales involve the sale by the
underwriters of a greater number of offered securities than they are required to purchase in an
offering. Stabilizing transactions consist of certain bids or purchases made for the purpose of
preventing or retarding a decline in the market price of the offered securities while an offering
is in progress.
The underwriters also may impose a penalty bid. This occurs when a particular underwriter
repays to the underwriters a portion of the underwriting discount received by it because the
underwriters have repurchased offered securities sold by or for the account of that underwriter in
stabilizing or short-covering transactions.
These activities by the underwriters may stabilize, maintain or otherwise affect the market
price of the offered securities. As a result, the price of the offered securities may be higher
than the price that otherwise might exist in the open market. If these activities are commenced,
they may be discontinued by the underwriters at any time. These transactions may be effected on an
exchange or automated quotation system, if the offered securities are listed on that exchange or
admitted for trading on that automated quotation system, or in the over-the-counter market or
otherwise.
Underwriters, dealers, agents and remarketing firms, or their affiliates, may be customers of,
engage in transactions with, or perform services for, us and our subsidiaries in the ordinary
course of business.
DESCRIPTION OF CAPITAL STOCK
The following information describes our common stock and provisions of our fourth amended and
restated certificate of incorporation and our third amended and restated bylaws as in effect as of
the date of this prospectus. This description is only a summary.
The following summary of our capital stock is qualified in its entirety by the description of
our common stock contained in our registration statement on Form 8-A filed with the SEC on August
8, 2005, including all amendments or reports filed for the purpose of updating such description,
and to our fourth restated certificate of incorporation and third amended and restated bylaws, as
amended from time to time, all of which are incorporated by reference as exhibits into the
registration statement of which this prospectus is a part. See Where You Can Find More
Information.
Common Stock
We are authorized to issue up to 30,000,000 shares of common stock, $0.001 par value per
share. As of May 31, 2008, there were 15,404,224 shares of our common stock outstanding held of
record by 188 stockholders.
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:
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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 any preferred stock that may be authorized. |
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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. |
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Preemptive rights, conversion and redemption. Our common stock is not entitled
to preemptive rights and is not subject to conversion or redemption. |
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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.
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 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.
The provisions in our fourth amended and restated certificate of incorporation and third
amended and restated bylaws with the intent described above include:
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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. |
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Removal of Directors. None of our directors may be removed other than for cause. |
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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. |
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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. |
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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 years 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. |
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No Cumulative Voting. There is no cumulative voting in the election of
directors. |
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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. |
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Regulatory Approval. We are also required to obtain the approval of certain
regulatory agencies, such as the FINRA, for certain transactions that could result
in a change of control. |
24
DESCRIPTION OF WARRANTS
The following statements with respect to the common stock warrants are summaries of, and
subject to, the detailed provisions of a stock warrant agreement to be entered into by us and a
stock warrant agent to be selected at the time of issue of the common stock warrants. The stock
warrant agreement may include or incorporate by reference standard warrant provisions substantially
in the form of the Common Stock Warrant Agreement to be filed in an amendment to the registration
statement which includes this prospectus or filed in a current report on Form 8-K and incorporated
by reference in the registration statement which includes this prospectus.
General
The common stock warrants, evidenced by stock warrant certificates, may be issued under a
stock warrant agreement independently or together with any other securities offered by any
prospectus supplement and may be attached to or separate from such other offered securities. If
stock warrants are offered, the applicable prospectus supplement will describe the designation and
terms of the stock warrants, including:
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the offering price, if any; |
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the designation and terms of the common stock purchasable upon exercise of the
stock warrants; |
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if applicable, the date on and after which the stock warrants and the related
offered securities will be separately transferable; |
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the number of shares of common purchasable upon exercise of one stock warrant
and the initial price at which the shares may be purchased upon exercise; |
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the date on which the right to exercise the stock warrants will commence and
expire; |
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a discussion of certain United States Federal income tax considerations; |
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the call provisions, if any; |
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the currency, currencies or currency units in which the offering price, if any,
and exercise price are payable; |
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any antidilution provisions of the stock warrants; and |
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any other terms of the stock warrants. |
The shares of common stock issuable upon exercise of the stock warrants will, when issued in
accordance with the stock warrant agreement, be fully paid and nonassessable.
Exercise of Stock Warrants
Stock warrants may be exercised by surrendering the stock warrant certificate to the stock
warrant agent with the form of election to purchase on the reverse side of the stock warrant
certificate properly completed and signed and by payment in full of the exercise price, as set
forth in the applicable prospectus supplement. The signature must be guaranteed by a bank or trust
company, by a broker or dealer which is a member of the National Association of Securities Dealers,
Inc. or by a member of a national securities exchange. Upon receipt of the certificates, the stock
warrant agent will requisition from the transfer agent for the common stock for issuance and
delivery to or upon the written order of the exercising warrantholder, a certificate representing
the number of shares of common stock purchased. If less than all of the stock warrants evidenced by
any stock warrant certificate are exercised, the stock warrant agent will deliver to the exercising
warrantholder a new stock warrant certificate representing the unexercised stock warrants.
25
No Rights as Stockholders
Holders of stock warrants will not be entitled, by virtue of being such holders, to vote, to
consent, to receive dividends, to receive notice as stockholders with respect to any meeting of
stockholders for the election of our directors or any other matter, or to exercise any rights
whatsoever as our stockholders.
Outstanding Warrants
Warrants outstanding at May 31, 2008 include a five-year warrant to purchase 75,000 shares of
our common stock at an exercise price of $7.00 per share issued to one of our consultants in 2004,
and seven-year warrants to purchase an aggregate of 52,646 shares of our common stock at an
exercise price of $4.52 per share issued in connection with the sale of our Series C redeemable
convertible preferred stock.
In connection with our initial public offering which closed on November 2, 2005, we issued
150,000 warrants to the underwriters to purchase shares of our common stock at $6.25 per share,
which became exercisable commencing October 28, 2006, and have a five-year term.
Additionally, in connection with our two private placement financings that closed on November
3, 2006 and August 2, 2007, respectively, the following warrants have been granted and remain
outstanding as of May 31, 2008:
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Financing that closed November 3, 2006: warrants to purchase up to 346,857
shares of our common stock were issued. The warrants are five-year warrants with an
exercise price of $6.70 per share; and |
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Financing that closed August 3, 2007: warrants to purchase up to 500,041 shares
of our common stock were issued. The warrants are five-year warrants with an
exercise price of $8.00 per share. |
DESCRIPTION OF UNITS
The following description, together with the additional information we may include in any
applicable prospectus supplements, summarizes the material terms and provisions of the units that
we may offer under this prospectus. While the terms we have summarized below will apply generally
to any units that we may offer under this prospectus, we will describe the particular terms of any
series of units in more detail in the applicable prospectus supplement. The terms of any units
offered under a prospectus supplement may differ from the terms described below. However, no
prospectus supplement will fundamentally change the terms that are set forth in this prospectus or
offer a security that is not registered and described in this prospectus at the time of its
effectiveness.
We will file as exhibits to the registration statement of which this prospectus is a part, or
will incorporate by reference from another report that we file with the SEC, the form of unit
agreement that describes the terms of the series of units we are offering, and any supplemental
agreements, before the issuance of the related series of units. The following summaries of material
terms and provisions of the units are subject to, and qualified in their entirety by reference to,
all the provisions of the unit agreement and any supplemental agreements applicable to a particular
series of units. We urge you to read the applicable prospectus supplements related to the
particular series of units that we sell under this prospectus, as well as the complete unit
agreement and any supplemental agreements that contain the terms of the units.
General
We may issue units comprised of common stock and warrants in any combination. Each unit will
be issued so that the holder of the unit is also the holder of each security included in the unit.
Thus, the holder of a unit will have the rights and obligations of a holder of each included
security. The unit agreement under which a unit is issued may provide that the securities included
in the unit may not be held or transferred separately, at any time or at any time before a
specified date.
We will describe in the applicable prospectus supplement the terms of the series of units,
including:
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the designation and terms of the units and of the securities comprising the
units, including whether and under what circumstances those securities may be held
or transferred separately; |
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any provisions of the governing unit agreement that differ from those described
below; and |
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any provisions for the issuance, payment, settlement, transfer or exchange of
the units or of the securities comprising the units. |
26
The provisions described in this section, as well as those described under Description of
Capital Stock and Description of Warrants will apply to each unit and to any common stock or
warrant included in each unit, respectively.
Issuance in Series
We may issue units in such amounts and in numerous distinct series as we determine.
Enforceability of Rights by Holders of Units
Each unit agent will act solely as our agent under the applicable unit agreement and will not
assume any obligation or relationship of agency or trust with any holder of any unit. A single bank
or trust company may act as unit agent for more than one series of units. A unit agent will have no
duty or responsibility in case of any default by us under the applicable unit agreement or unit,
including any duty or responsibility to initiate any proceedings at law or otherwise, or to make
any demand upon us. Any holder of a unit may, without the consent of the related unit agent or the
holder of any other unit, enforce by appropriate legal action its rights as holder under any
security included in the unit.
LEGAL MATTERS
For the purposes of this offering, Dreier LLP, New York, New York is passing upon the validity
of the securities offered by this prospectus.
EXPERTS
The financial statements incorporated in this prospectus by reference from our Annual Report
on Form 10-K, for the year ended December 31, 2007 have been audited by Eisner LLP, an independent
registered public accounting firm as stated in their report incorporated herein by reference, which
report has been so incorporated in reliance upon the report of such firm given upon their authority
as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
Federal securities laws require us to file information with the SEC concerning our business
and operations. Accordingly, we file annual, quarterly and current reports, proxy statements and
other information with the SEC. You may read and copy any document we file at the SECs public
reference rooms, including those located at 100 F Street, N.E., Washington, D.C. 20549. Please
call the SEC at 1-800-SEC-0330 for further information on public reference rooms. Our SEC filings
are also available to the public from the SECs web site at http://www.sec.gov.
We have filed with the SEC a registration statement on Form S-3 under the Securities Act with
respect to the securities being offering under this prospectus. This prospectus, which is a part of
that registration statement, does not include all the information contained in the registration
statement and its exhibits. For further information with respect to our company and the securities,
you should consult the registration statement and its exhibits. Statements contained in this
prospectus concerning the provisions of any documents are summaries of those documents, and we
refer you to the document filed with the SEC for more information. The registration statement and
any of its amendments, including exhibits filed as a part of the registration statement or an
amendment to the registration statement, are available for inspection and copying as described
above.
The SEC allows us to incorporate by reference certain information we file with them in this
prospectus. This means that we can disclose important information to you by referring you to the
other information we have filed with the SEC. The information that we incorporate by reference is
considered to be part of this prospectus. Information that we file later with the SEC will
automatically update and supersede this information. Further, all filings we make under the
Exchange Act prior to the termination of the offering shall be deemed to be incorporated by
reference into this prospectus. The following documents filed by us with the SEC and any future
filings under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act (File No. 000-51481) made
prior to the termination of this offering are incorporated by reference:
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our Annual Report on Form 10-K for the year ended December 31, 2007, filed March 12,
2008; |
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our Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, filed May 8,
2008; |
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our Current Reports on Form 8-K filed on January 2, 2008, January 9, 2008, February
12, 2008, May 1, 2008 and June 11, 2008; and |
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the description of our common stock contained in our registration statement on Form
8-A, as filed on August 8, 2005 with the SEC, as it may be amended from time to time. |
27
This prospectus may contain information that updates, modifies or is contrary to information
in one or more of the documents incorporated by reference in this prospectus. Reports we file with
the SEC after the date of this prospectus may also contain information that updates, modifies or is
contrary to information in this prospectus or in documents incorporated by reference in this
prospectus. Investors should review these reports as they may disclose a change in our business,
prospectus, financial condition or other affairs after the date of this prospectus.
Our website is http://www.eosciences.com. Our website links to our filings available
on the SEC website. We will also provide electronic or paper copies of our filings free of charge
upon written or oral request. Information contained on our website or any other website is not
incorporated into this prospectus and does not constitute a part of this prospectus. You can
request a free copy of the above filings or any filings subsequently incorporated by reference into
this prospectus by writing or calling us at:
Electro-Optical Sciences, Inc.
3 West Main Street, Suite 201
Irvington, New York 10533
Attention: Richard I. Steinhart, Chief Financial Officer
(914) 591-3783
WE HAVE NOT AUTHORIZED ANY DEALER, SALES PERSON OR OTHER PERSON TO GIVE ANY INFORMATION OR TO MAKE
ANY REPRESENTATIONS OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS. THIS PROSPECTUS IS NOT AN OFFER
OF THESE SECURITIES IN ANY STATE WHERE AN OFFER IS NOT PERMITTED. THE INFORMATION IN THIS
PROSPECTUS IS CURRENT AS OF JUNE 26, 2008. YOU SHOULD NOT ASSUME THAT THIS PROSPECTUS IS ACCURATE
AS OF ANY OTHER DATE.
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ELECTRO-OPTICAL SCIENCES, INC.
$40,000,000
COMMON STOCK
WARRANTS
UNITS
PROSPECTUS
, 2008
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses Of Issuance And Distribution
The following table sets forth the costs and expenses, other than placement agent commissions,
if any, which will be paid by us, in connection with the distribution of the common stock being
registered. All amounts are estimated, except the SEC registration fee:
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SEC registration fee |
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1,572 |
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Accounting fees and expenses |
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10,000 |
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Legal fees and expenses |
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25,000 |
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Printing and miscellaneous expenses |
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Total |
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36,572 |
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Item 15. 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 fourth amended and restated certificate of incorporation provides for the
indemnification of directors to the fullest extent permissible under Delaware law.
Article IX of our third 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.
We have agreed to enter into Indemnification Agreements with each of our current directors and
officers to provide such directors and officers additional contractual assurances regarding the
scope of the indemnification set forth in our amended and 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 any of our directors, officers or employees regarding
which indemnification is sought. The indemnification provision in our amended and restated
certificate of incorporation, amended and restated bylaws and the indemnification agreements
between us and each of our directors and officers may be sufficiently broad to permit
indemnification of our directors and officers for liabilities arising under the Securities Act.
We have directors and officers liability insurance for securities matters prior to the
closing of this offering.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to our directors, officers and controlling persons pursuant to the foregoing provisions, or
otherwise, we have been advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act, and is, therefore,
unenforceable.
II-1
Item 16. Exhibits
EXHIBIT NO. DESCRIPTION
1.1 |
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Form of Underwriting Agreement. 1 |
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3.1 |
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Fourth Amended and Restated Certificate of Incorporation of the Company, as amended.2 |
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3.2 |
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Third Amended and Restated By-laws of Company.3 |
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4.1 |
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Specimen Common Stock Certificate.4 |
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4.2 |
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Form of Common Stock Warrant Agreement and Warrant Certificate.1 |
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4.3 |
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Form of Unit Agreement.1 |
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5.1 |
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Opinion of Dreier LLP. |
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23.1 |
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Consent of Dreier LLP (included in Exhibit 5.1). |
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23.2 |
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Consent of Eisner LLP. |
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24.1 |
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Power of Attorney (included as part of the signature page of this Registration Statement). |
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1 |
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To be filed, if necessary, subsequent to the effectiveness of this registration
statement by an amendment to this registration statement or incorporated by reference pursuant
to a Current Report on Form 8-K in connection with the offering of securities. |
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2 |
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Incorporated by reference to our Registration Statement on Form S-1, as amended (File
No. 333-125517), as filed on July 15, 2005. |
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Incorporated by reference to our Registration Statement on Form S-1, as amended (File
No. 333-125517), as filed on August 8, 2005. |
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Incorporated by reference to our Registration Statement on Form S-1, as amended (File
No. 333-125517), as filed on August 8, 2005. |
Item 17. Undertakings
(a) |
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The undersigned registrant hereby undertakes: |
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To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement: |
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of
1933.
(ii) To reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar value of securities offered
would not exceed that which was registered) and any deviation from the low or high and of
the estimated maximum offering range may be reflected in the form of prospectus filed with
the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and
price represent no more than a 20 percent change in the maximum aggregate offering price
set forth in the Calculation of Registration Fee table in the effective registration
statement.
II-2
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such
information in the registration statement.
Provided, however, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do
not apply if the registration statement is on Form S-3 and the information required to be
included in a post-effective amendment by those paragraphs is contained in reports filed
with or furnished to the Commission by the registrant pursuant to Section 13 or Section
15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the
registration statement, or is contained in a form of prospectus filed pursuant to Rule
424(b) that is part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment 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.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act of 1933 to any
purchaser, if the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b)
as part of a registration statement relating to an offering, other than registration statements
relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to
be part of and included in the registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a registration statement or prospectus
that is part of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale prior to such first
use, supersede or modify any statement that was made in the registration statement or prospectus
that was part of the registration statement or made in any such document immediately prior to such
date of first use.
(5) That, for the purpose of determining liability of the registrant under the Securities Act
of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant
undertakes that in a primary offering of securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the following
communications, the undersigned registrant will be a seller to the purchaser and will be considered
to offer or sell such securities to such purchaser: (i) any preliminary prospectus or prospectus of
the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; (ii)
any free writing prospectus relating to the offering prepared by or on behalf of the undersigned
registrant or used or referred to by the undersigned registrant; (iii) the portion of any other
free writing prospectus relating to the offering containing material information about the
undersigned registrant or its securities provided by or on behalf of the undersigned registrant;
and (iv) any other communication that is an offer in the offering made by the undersigned
registrant to the purchaser.
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The undersigned registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act of 1933, each filing of the registrants annual report pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each
filing of an employee benefit plans annual report pursuant to Section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in the registration statement 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. |
(c) |
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Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed
in the Securities Act of 1933 and is, therefore, unenforceable. |
II-3
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 of 1933 and will
be governed by the final adjudication of such issue.
(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 will 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 will be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time will
be deemed to be the initial bona fide offering thereof.
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this Registration Statement to be signed on its behalf by
the undersigned, thereunto duly authorized, in Irvington, New York, on this 26 day of June, 2008.
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ELECTRO-OPTICAL SCIENCES, INC.
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By: |
/s/ Joseph V. Gulfo
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Joseph V. Gulfo |
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President and Chief Executive Officer |
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POWER OF ATTORNEY
Each person whose signature appears below hereby constitutes and appoints Joseph V. Gulfo and
Richard I. Steinhart, and each of them, his true and lawful attorney-in-fact and agent, with full
power of substitution and resubstitution, for him and in his name, place and stead, in any and all
capacities, to sign any and all amendments (including, without limitation, post-effective
amendments) to this Registration Statement, and to file the same, with all exhibits thereto, and
other documents in connection therewith, with the Securities and Exchange Commission, granting unto
said attorneys-in-fact and agents, and each of them, full power and authority to do and perform
each and every act and thing requisite and necessary to be done in and about the premises, as fully
to all intents and purposes as each of them might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents or any of them, or their or his substitute or
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration
Statement has been signed by the following persons in the capacities and on the date indicated.
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SIGNATURE |
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TITLE |
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DATE |
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/s/ Joseph V. Gulfo
Joseph V. Gulfo, M.D., M.B.A.
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Director, President and Chief
Executive Officer
(Principal Executive Officer)
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June 26, 2008 |
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/s/ Richard I. Steinhart
Richard I. Steinhart
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Vice President, Finance and Chief
Financial Officer
(Principal Financial and Accounting Officer)
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June 26, 2008 |
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/s/ Breaux Castleman
Breaux Castleman
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Chairman of the Board of Directors
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June 26, 2008
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/s/ Sidney Braginsky
Sidney Braginsky
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Director
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June 26, 2008 |
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/s/ George C. Chryssis
George C. Chryssis
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Director
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June 26, 2008 |
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/s/ Martin D. Cleary
Martin D. Cleary
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Director
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June 26, 2008 |
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/s/ Dan W. Lufkin
Dan W. Lufkin
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Director
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June 26, 2008 |
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/s/ Gerald Wagner, PhD.
Gerald Wagner, Phd.
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Director
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June 26, 2008 |
II-5
EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
1.1 |
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Form of Underwriting Agreement. 1 |
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3.1 |
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Fourth Amended and Restated Certificate of Incorporation of the Company, as amended.2 |
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3.2 |
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Third Amended and Restated By-laws of Company.3 |
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4.1 |
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Specimen Common Stock Certificate.4 |
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4.2 |
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Form of Common Stock Warrant Agreement and Warrant Certificate.1 |
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4.3 |
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Form of Unit Agreement.1 |
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5.1 |
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Opinion of Dreier LLP. |
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23.1 |
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Consent of Dreier LLP (included in Exhibit 5.1). |
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23.2 |
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Consent of Eisner LLP. |
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24.1 |
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Power of Attorney (included as part of the signature page of this Registration Statement). |
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1 |
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To be filed, if necessary, subsequent to the effectiveness of this registration
statement by an amendment to this registration statement or incorporated by reference pursuant
to a Current Report on Form 8-K in connection with the offering of securities. |
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2 |
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Incorporated by reference to our Registration Statement on Form S-1, as amended (File
No. 333-125517), as filed on July 15, 2005. |
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3 |
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Incorporated by reference to our Registration Statement on Form S-1, as amended (File
No. 333-125517), as filed on August 8, 2005. |
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4 |
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Incorporated by reference to our Registration Statement on Form S-1, as amended (File
No. 333-125517), as filed on August 8, 2005. |
EX-5.1
Exhibit 5.1
[Dreier LLP Letterhead]
June 26, 2008
Electro-Optical Sciences, Inc.
3 West Main Street
Suite 201
Irvington, New York 10533
Ladies and Gentlemen:
We have acted as counsel to Electro-Optical Sciences, Inc., a Delaware corporation (the
Company), in connection with its filing on the date hereof of the Registration Statement on Form
S-3 (the Registration Statement) under the Securities Act of 1933, as amended (the Act), with
the Securities and Exchange Commission (the SEC). The Registration Statement relates to the
proposed offer and sale by the Company from time to time, as set forth in the prospectus contained
in the Registration Statement (the Prospectus) and as shall be set forth in one or more
supplements to the Prospectus (each, a Prospectus Supplement), of an aggregate offering price of
up to $40,000,000 of securities (the Securities) which may include any or all of the following:
(i) shares of common stock, par value $0.001 per share, of the Company (the Common Stock); (ii)
warrants to purchase shares of Common Stock (the Warrants); and (iii) units comprised of Common
Stock and Warrants (the Units).
In connection with this opinion letter, we have examined the Registration Statement,
originals, or copies certified or otherwise identified to our satisfaction, of the Certificate of
Incorporation, as amended through the date hereof (the Certificate), and Bylaws, as in effect on
the date hereof (the Bylaws), of the Company, certain resolutions of the Companys Board of
Directors relating to the Registration Statement, and such other documents, records and other
instruments as we have deemed appropriate for purposes of the opinion set forth herein.
We have assumed the genuineness of all signatures, the legal capacity of all natural persons,
the authenticity of the documents submitted to us as originals, the conformity with the originals
of all documents submitted to us as certified, facsimile or photostatic copies and the authenticity
of the originals of all documents submitted to us as copies. With respect to matters of fact
relevant to our opinions as set forth below, we have relied upon certificates of officers of the
Company, representations made by the Company in documents examined by us and representations of
officers of the Company. We have also obtained and relied upon such certificates and assurances
from public officials as we have deemed necessary for the purposes of our opinions set forth below.
For the purpose of the opinions set forth below, we have also assumed, without independent
investigation or verification, that:
(a) the issuance, sale, number or amount, as the case may be, and terms of Securities to be
offered from time to time will be duly authorized and established, in accordance with the
Certificate, the Bylaws and applicable Delaware law (each, a Corporate Action), and will not
conflict with or constitute a breach of the terms of any agreement or instrument to which the
Company is subject;
(b) any Warrants will be issued under one or more warrant agreements (each, a Warrant
Agreement) between the Company and the financial institution identified in the Warrant Agreement
as a warrant agent (each, a Warrant Agent) and/or the
person or persons identified in the Warrant Agreement as the holder
or holders of such Warrants (each a Warrant Holder) and the execution, delivery and performance of the
applicable Warrant Agreement will be duly authorized by Corporate Action, and will not conflict
with or constitute a breach of the terms of any agreement or instrument to which the Company is
subject;
(c) any Units will be issued under one or more unit agreements (each, a Unit Agreement and
together with Warrant Agreements, the Agreements) between
the Company and the financial institution identified in the Unit
Agreement as a unit agent (each, a Unit Agent) and/or the
person or persons identified in the Unit Agreement as the holder or
holders of such Units (each a Unit Holder) and the
execution, delivery and performance of the applicable Unit Agreement will be duly authorized by
Corporate Action, and will not conflict with or constitute a breach of the terms of any agreement
or instrument to which the Company is subject;
(d) to the extent that the obligations of the Company under any Agreements may depend upon
such matters, each of the parties thereto other than the Company, is duly organized, validly
existing and in good standing under the laws of its jurisdiction of organization and is duly
qualified to engage in the activities contemplated by such Agreement; that such Agreement has been
duly authorized, executed and delivered by such party and constitutes the legal, valid and binding
obligation of such party, enforceable against such party in accordance with its terms; that such
party is in compliance, generally and with respect to acting as a party with respect to its
obligations under such Agreement, with all applicable laws and regulations; and that such party has
the requisite organizational and legal power and authority to perform its obligations under such
Agreement;
(e) the Registration Statement and any amendments thereto (including post-effective
amendments) will have become effective and will comply with all applicable federal and state laws
at the time the Securities are offered and issued as contemplated by the Registration Statement;
(f) a Prospectus Supplement will have been prepared and filed with the SEC describing the
Securities offered thereby and will comply with all applicable laws at the time the Securities are
offered and issued as contemplated by the Registration Statement;
(g) all Securities will be issued and sold in compliance with applicable federal and state
securities laws; and
(h) a definitive purchase, underwriting or similar agreement with respect to any Securities
offered or issued will have been duly authorized and validly executed and delivered by the Company
and the other parties thereto.
Subject to the foregoing and the other matters set forth herein, it is our opinion that, as of
the date hereof:
1. Upon due authorization by Corporate Action of the issuance and sale of shares of the Common
Stock and upon issuance and delivery of such shares of Common Stock against payment for such shares
(in an amount at least equal to the aggregate par value of such shares of the Common Stock) in
accordance with the terms of the Corporate Action and as contemplated by the Registration Statement
and the applicable Prospectus Supplement, and, if applicable, upon the conversion, exchange or
exercise of any other Securities in accordance with their respective terms, the terms of the
Corporate Action and as contemplated by the Registration Statement and the applicable Prospectus
Supplement (which shall, in each case, provide for payment of consideration that shall be at least
equal to the aggregate par value of such shares of the Common Stock), such shares of Common Stock
will be validly issued, fully paid and nonassessable.
2. When a Warrant Agreement providing for the specific terms of a particular issuance of
Warrants has been duly authorized by Corporate Action and has been duly executed and delivered by
the Company, the Warrant Agent named in such Warrant Agreement and
such Warrants and/or the Warrant Holder named in such Warrant
Agreement and such Warrants, conforming to
the requirements of such Warrant Agreement, have been duly countersigned or authenticated, as
required, by such Warrant Agent and/or Warrant Holder and duly executed and delivered by the Company against payment for
such Warrants in accordance with the terms and provisions of such Warrant Agreement, the terms of
the Corporate Action and as contemplated by the Registration Statement and the applicable
Prospectus Supplement, such Warrants will be valid, binding and enforceable obligations of the
Company.
3. When a Unit Agreement providing for the specific terms of a particular issuance of Units
has been duly authorized by Corporate Action and has been duly executed and delivered by the
Company, the Unit Agent named in such Unit Agreement and such Units
and/or the Unit Holder named in such Unit Agreement and such Units, conforming to the
requirements of such Unit Agreement, have been duly countersigned or authenticated, as required, by such Unit Agent
and/or Unit Holder and duly executed and delivered by the Company against payment for such Units in accordance with
the terms and provisions of such Unit Agreement, the terms of the Corporate Action and as
contemplated by the Registration Statement and the applicable Prospectus Supplement, such Units
will be valid, binding and enforceable obligations of the Company.
The opinions set forth above as to enforceability may be limited by: (i) the effect of
bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or other similar laws now
or hereafter in effect relating to or affecting the rights or remedies of creditors generally; (ii)
the effect of general principles of equity, whether enforcement is considered in a proceeding in
equity or at law, and the discretion of the court before which any proceeding therefor may be
brought; or (iii) the unenforceability under certain circumstances under law or court decisions of
provisions providing for the indemnification of or contribution to a party with respect to a
liability where such indemnification or contribution is contrary to public policy.
Our opinion expressed above is limited to the General Corporation Law of the State of
Delaware. We express no opinions as to any other laws, statutes, rules or regulations.
We hereby consent to the use of this opinion as Exhibit 5.1 to the Registration Statement and
to the reference to this firm under the caption Legal Matters. In giving such opinion, we do not
thereby admit that we are acting within the category of persons whose consent is required under
Section 7 of the Act or the rules and regulations of the SEC thereunder.
Very truly yours,
/s/ Dreier LLP
EX-23.2
Exhibit 23.2
Consent of Independent Registered Public Accounting Firm
We consent to the use of our report dated March 10, 2008 on the financial statements of
Electro-Optical Sciences, Inc. as of December 31, 2007 and 2006, and for each of the years in the
three-year period ended December 31, 2007, and our report dated March 10, 2008 on our audit of the
Companys internal control over financial reporting as of December 31, 2007, incorporated by
reference herein and to the reference to our firm under the heading Experts in the registration
statement on Form S-3, to be filed on our about June 26, 2008.
/s/ Eisner, LLP
New York, NY
June 23, 2008