IRVINGTON, NY -- (Marketwire) -- 08/04/09 -- Electro-Optical Sciences, Inc. ("EOS")
(NASDAQ: MELA) announced today that the U.S. Food and Drug Administration
(FDA) formally accepted for filing the company's Pre-Market Approval (PMA)
application for MelaFind®, a non-invasive and objective computer vision
system intended to aid in the early detection of melanoma. The FDA's
action means that the PMA application was sufficiently complete and ready
for substantive review. The filing date for regulatory purposes is June 9,
2009, the date the FDA received EOS' PMA submission. The FDA also
confirmed that the PMA application will receive expedited review and
processing.
"We're extremely pleased that the FDA has formally accepted the MelaFind®
PMA for review. This brings us one step closer to realizing our goal of
offering clinicians a reliable tool to help them to detect melanoma while
it is still in its earliest, most curable stages," said Joseph V. Gulfo,
M.D., President and CEO. "We look forward to advancing our discussions with
the FDA and obtaining the agency's feedback on the MelaFind® PMA and next
steps in the review process."
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
2009. 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 Electro-Optical Sciences
Electro-Optical Sciences is a medical technology company focused on
developing MelaFind®, a non-invasive and objective computer vision system
intended to aid in the early detection of melanoma. EOS 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.
Although the MelaFind® PMA is subject to the FDA's expedited review
procedures, EOS 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 EOS, visit www.eosciences.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.
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