MELA Sciences Announces FDA Needs More Time to Review MelaFind® PMA Application

MELA Sciences, Inc. 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 FDA's decision on the PMA application or the outcome.
FDA approval is required prior to marketing MelaFind in the United
States.

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