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"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.
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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.
For further information contact: David Carey Lazar Partners Ltd. 212-867-1768 Email Contact
SOURCE: Electro Optical Sciences
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