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Electro-Optical Sciences Completes Patient Accrual in MelaFind(R) Pivotal Trial for Early Melanoma Detection
| Source: Electro Optical Sciences
IRVINGTON, NY--(Marketwire - August 4, 2008) - Electro-Optical Sciences, Inc. ("EOS")
(NASDAQ : MELA ) today announced that patient accrual in the MelaFind®
pivotal trial was completed last week. MelaFind is a non-invasive,
point-of-care instrument designed and developed by EOS to assist in the
early diagnosis of melanoma, the deadliest form of skin cancer.
"This represents a significant milestone for the company in our quest to
improve early melanoma detection," said Joseph V. Gulfo, MD, MBA, President
& CEO. "We would like to thank the dedicated physicians, nurses, and staff
at our clinical trial sites, and most notably, the patients for their
willingness to participate in this landmark study."
MelaFind features a hand-held imaging device that emits multiple
wavelengths of light to obtain thousands of characteristics of suspicious
pigmented skin lesions up to 2.5 mm deep into the skin. The system uses
sophisticated, proprietary algorithms to analyze these data against a
proprietary database of melanomas and benign lesions. Based on the
analysis, the system generates an objective, detailed report with an
immediate recommendation of whether the lesion should be biopsied.
The blinded pivotal trial, which will serve as the basis for the company's
Pre-Market Approval (PMA) application with the U.S. Food and Drug
Administration (FDA), was conducted at seven centers in the U.S.
Investigators used the MelaFind system to evaluate over 1,800 suspicious
lesions from over 1,300 patients. All the suspicious lesions were
subsequently biopsied and sent for dermatohistopathologic analysis.
Results of the pivotal trial are anticipated in the fourth quarter, with
PMA filing to follow.
Cancers of the skin have a higher incidence than all other cancers with
melanoma being the deadliest form of skin cancer responsible for
approximately 80% of the skin cancer fatalities. The melanoma rate has
continued to increase with an estimated 120,000 new cases of melanoma
projected in 2008. A recent National Cancer Institute report published in
the July 10 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. Although no cure is currently
available for advanced stage melanoma, if caught early, melanoma is
virtually 100% curable.
About Electro-Optical Sciences
EOS is a medical device company focused on designing and developing a
non-invasive, point-of-care instrument to assist in the early diagnosis of
melanoma. MelaFind features a hand-held imaging device that emits light of
multiple wavelengths to capture images of suspicious pigmented skin lesions
and extract data. Using sophisticated algorithms, the data are then
analyzed against a proprietary database of melanomas and benign lesions in
order to provide information to the physician and produce a recommendation
of whether the lesion should be biopsied.
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.