FDA Accepts Electro-Optical Sciences, Inc.'s MelaFind(R) Pre-Market Approval (PMA) Application for Review

August 4, 2009 |

3 min read

IRVINGTON, NY--(Marketwire - August 04, 2009) - Electro-Optical Sciences, Inc. (“EOS”) (NASDAQ: MELA) announced today that the U.S. Food and Drug Administration (FDA) formally accepted for filing the company’s Pre-Market Approval (PMA) application for MelaFind®, a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. The FDA’s action means that the PMA application was sufficiently complete and ready for substantive review. The filing date for regulatory purposes is June 9, 2009, the date the FDA received EOS’ PMA submission. The FDA also confirmed that the PMA application will receive expedited review and processing.

“We’re extremely pleased that the FDA has formally accepted the MelaFind® PMA for review. This brings us one step closer to realizing our goal of offering clinicians a reliable tool to help them to detect melanoma while it is still in its earliest, most curable stages,” said Joseph V. Gulfo, M.D., President and CEO. “We look forward to advancing our discussions with the FDA and obtaining the agency’s feedback on the MelaFind® PMA and next steps in the review process.”

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.

Although the MelaFind® PMA is subject to the FDA’s expedited review procedures, EOS cannot predict either the timing of the FDA’s decision on the PMA application or the outcome. FDA approval is required prior to marketing MelaFind® in the United States.

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.