NEWS: Electro-Optical Sciences submits MelaFind application to FDA
http://medicalphysicsweb.org/cws/article/newsfeed/39407
June 8, 2009
IRVINGTON, NY, 4 June 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(R), 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.
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