SOURCE: MELA Sciences
March 02, 2011 07:30 ET
Company Files MelaFind® PMA Amendment With U.S. Food and Drug Administration
Company Also Provides Operational Update
IRVINGTON, NY--(Marketwire - March 2, 2011) - MELA Sciences (NASDAQ: MELA) today announced that the company has filed an amendment to the MelaFind® pre-market approval (PMA) application with the U.S. Food and Drug Administration (FDA), limiting the indication for use to dermatologists.
"We have clarified the intended use of MelaFind to dermatologists as a response to public statements made by several dermatologists sitting on the November 18, 2010 MelaFind FDA review panel," said Joseph Gulfo, MD, President and CEO, MELA Sciences. "We look forward to working with the Agency to move the MelaFind PMA application forward. On a parallel track, we are seeking to obtain a CE Mark for MelaFind from European regulatory authorities and hope to receive it in the second half of this year."
The company also announced that it was recently issued a patent protecting its methods associated with the quantitative and objective analysis of the traditional "ABCD" skin characteristics. Asymmetry, Border irregularity, Color and Diameter are four characteristics used to identify lesions that require further evaluation by physicians to rule out melanoma.
Separately, in connection with preparing the company's proxy materials, board member Charlie Stiefel advised the company that, for personal reasons, he would not seek reelection to the board in 2011 and tendered his resignation from the board. "We would like to extend our gratitude to Charlie for his service. We sincerely appreciate his counsel and contributions to our organization," added Dr. Gulfo.
About MELA Sciences
MELA Sciences is a medical technology company focused on developing MelaFind®. MelaFind® is a non-invasive and objective multi-spectral computer vision system designed to aid physicians in the detection of early melanoma from among clinically atypical (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 millimeters, evolving, patient concern, regression, and ugly duckling) cutaneous pigmented lesions that are non-ulcerated, not bleeding, and less than 2.2 centimeters in diameter, when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.
The MelaFind® Pre-Market Approval (PMA) application was filed with the U.S. Food and Drug Administration (FDA) in June 2009, received positive FDA Advisory Panel recommendations in November 2010 and is currently under review at the FDA. MELA Sciences 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 MELA Sciences, visit www.melasciences.com.
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.