SOURCE: MELA Sciences

MELA Sciences

November 16, 2010 09:08 ET

FDA's General and Plastic Surgery Devices Panel to Review MelaFind® on Thursday, November 18

IRVINGTON, NY--(Marketwire - November 16, 2010) - MELA Sciences, Inc. (NASDAQ: MELA) today announced that the U.S. Food and Drug Administration's (FDA) General and Plastic Surgery Devices Panel will review the company's Pre-Market Approval (PMA) application for MelaFind® on Thursday, November 18 at 8:00am ET. The advisory committee meeting will take place at the Holiday Inn College Park, Grand Ballroom, 10000 Baltimore Ave., College Park, MD., and is open to the public.

The FDA has posted briefing documents pertaining to the upcoming meeting on its website. For additional information related to MelaFind, the PMA and the pivotal trial, visit the investor relations section of the MELA Science's website at http://phx.corporate-ir.net/phoenix.zhtml?c=191863&p=irol-irhome

About MELA Sciences

MELA Sciences is a medical technology company focused on developing MelaFind®. MelaFind® is a non-invasive and objective multi-spectral computer vision system designed to aid physicians in the detection of early melanoma from among clinically atypical (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 millimeters, evolving, patient concern, regression, and ugly duckling) cutaneous pigmented lesions that are non-ulcerated, not bleeding, and less than 2.2 centimeters in diameter, when a physician chooses to obtain additional information before making a final decision to 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 FDA's 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.

About Melanoma

Melanoma is the deadliest form of skin cancer, responsible for approximately 75% 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.

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.

Contact Information

  • For further information contact:

    For Investors:
    David Carey
    Lazar Partners, Ltd.
    646-871-8485

    For Media:
    Hollister Hovey
    Lazar Partners, Ltd.
    646-871-8485