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Electro-Optical Sciences Submits MelaFind(R) Pre-Market Approval Application to FDA
| Source: Electro-Optical Sciences, Inc.
IRVINGTON, NY--(Marketwire - June 4, 2009) - Electro-Optical Sciences, Inc. ("EOS")
(NASDAQ : MELA ) today announced the submission to the United States Food and
Drug Administration (FDA) of its Premarket Approval (PMA) application for
MelaFind®, a non-invasive, point-of-care instrument to assist in the
early diagnosis of melanoma, the leading cause of death from skin cancer.
Positive top line data from the MelaFind pivotal study, the largest
prospective clinical study ever conducted in melanoma detection, were
announced in February and subsequently presented at several major
international dermatology meetings in March and May of this year. The
company's final analysis of the data demonstrated that for all subgroups
analyzed, the sensitivity of MelaFind was greater than 95% (lower
confidence bound) and MelaFind specificity was statistically significantly
higher than that of study clinicians. As announced previously, the FDA has
granted Expedited Review for the MelaFind PMA.
"We believe the final results of the MelaFind pivotal study met the study
endpoints and that the pivotal trial satisfied the specifications of the
Protocol Agreement with the FDA under which it was conducted," said Joseph
V. Gulfo, MD, President & CEO. "We look forward to working with the FDA in
the review of the MelaFind application."
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.
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.