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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 21, 2010
MELA Sciences, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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000-51481
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13-3986004 |
(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.) |
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50 South Buckhout Street, Suite 1 |
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Irvington, New York
(Address of principal executive offices)
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10533
(Zip Code) |
Registrants telephone number, including area code (914) 591-3783
Electro-Optical Sciences, Inc.
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instructions
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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On July 21, 2010, MELA Sciences, Inc. issued a press release, a copy of which is attached as
Exhibit 99.1 to this report and is incorporated herein by reference.
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Item 9.01 |
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Financial Statements and Exhibits |
(d) Exhibits.
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EXHIBIT NO. |
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DESCRIPTION |
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99.1 |
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MELA Sciences, Inc. Press Release, dated July 21, 2010 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
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MELA Sciences, Inc.
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Date: July 21, 2010 |
By: |
/s/ Richard I. Steinhart
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Chief Financial Officer |
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(Principal Financial Officer) |
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EXHIBIT INDEX
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EXHIBIT NO. |
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DESCRIPTION |
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99.1 |
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MELA Sciences, Inc. Press Release, dated July 21, 2010 |
exv99w1
Exhibit 99.1
MELA Sciences Announces FDA Needs More Time to Arrange Panel
Meeting to Review
MelaFind®
PMA Application
IRVINGTON, NY (July 21, 2010) MELA Sciences, Inc. (Nasdaq: MELA) announced today that the U.S.
Food and Drug Administration (FDA) has informed the company that it is moving the General and
Plastic Surgery Devices Panel for MelaFind®, which was originally scheduled for August
26, 2010, to November 2010.
The
FDA informed us today that more time is required to arrange the meeting, said Joseph V. Gulfo,
MD, President & CEO. We are ready to go now, and we will maintain our state of preparedness.
This is untimely, however, it is not totally surprising given that the meeting
was originally scheduled for the last week of the summer. We look forward to the revised Federal
Register announcement of the specific date in November.
About Melanoma
Melanoma is the deadliest form of skin cancer, responsible for approximately 80% of skin cancer
fatalities. The melanoma rate has continued to increase with an estimated 120,000 new cases
projected in 2010. A recent National Cancer Institute report published in the July 10, 2008 online
edition of the Journal of Investigative Dermatology indicates that annual incidence of melanoma
among young adult Caucasian women rose 50% between 1980 and 2004. Melanoma is the most common
cancer in women age 25 to 29 and the number one cancer killer of women age 30 to 35. Although no
cure is currently available for advanced-stage melanoma, if caught early, melanoma is virtually
100% curable.
About MELA Sciences
MELA Sciences is a medical technology company focused on developing MelaFind®, a non-invasive and
objective computer vision system intended to aid in the detection of early melanoma. MELA Sciences
designed MelaFind to assist in the evaluation of pigmented skin lesions, including atypical moles,
which have one or more clinical or historical characteristics of melanoma, before a final decision
to biopsy has been rendered. MelaFind acquires and displays multi-spectral (from blue to near
infrared) digital images of pigmented skin lesions and uses automatic image analysis and
statistical pattern recognition to help identify lesions to be considered for biopsy to rule out
melanoma.
The MelaFind Pre-Market Approval (PMA) application was filed with the U.S. Food and Drug
Administration (FDA) in June 2009 and is currently under review at the FDA. MELA Sciences cannot
predict either the timing of the FDAs decision on the PMA application or the outcome. FDA approval
is required prior to marketing MelaFind in the United States.
For more information on MELA Sciences, visit www.melasciences.com.
Safe Harbor
This press release includes forward-looking statements within the meaning of the Securities
Litigation Reform Act of 1995. These statements include but are not limited to our plans,
objectives, expectations and intentions and other statements that contain words such as expects,
contemplates, anticipates, plans, intends, believes and variations of such words or
similar expressions that predict or indicate future events or trends, or that do not relate to
historical matters. These statements are based on our current beliefs or expectations and are
inherently subject to significant uncertainties and changes in circumstances, many of which are
beyond our control. There can be no assurance that our beliefs or expectations will be achieved.
Actual results may differ materially from our beliefs or expectations due to economic, business,
competitive, market and regulatory factors.
For further information contact:
For Investors:
David Carey
Lazar Partners, Ltd.
646-871-8485
For Media:
Hollister Hovey
Lazar Partners, Ltd.
646-871-8485