Electro-Optical Sciences, Inc. Submits MelaFind(R) Pre-Market Approval Application to FDA
Published: Jun 04, 2009
IRVINGTON, NY--(MARKET WIRE)--Jun 4, 2009 -- Electro-Optical Sciences, Inc. ("EOS") (NasdaqCM:MELA - News) 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."
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.
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For further information contact:
Investors David Carey Lazar Partners Ltd. 212-867-1768
Media Hollister Hovey Lazar Partners Ltd. 646-871-8482