SOURCE: MELA Sciences

MELA Sciences

July 21, 2011 07:00 ET

MELA Sciences Responds to Congressional Testimony on Medical Device Regulation at the FDA

IRVINGTON, NY--(Marketwire - Jul 21, 2011) - MELA Sciences Inc. (NASDAQ: MELA) issued the following statements after yesterday's hearing on "Regulatory Reform Series #5 - FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs" by the U.S. House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations.

The subcommittee examined the impact regulations in the medical device industry have on patient access, innovation, and job creation. The FDA's ongoing two-year premarket review of MELA Sciences' investigational MelaFind® device was examined by members of the subcommittee and discussed by witness Michael Mandel, PhD, Chief Economic Strategist, Progressive Policy Institute (PPI).

"MELA Sciences is gratified that the Congressional Subcommittee on Oversight and Investigations recognizes the U.S. Food and Drug Administration's important role in promoting technological innovation in health care and wants to help the agency do more," said Joseph V. Gulfo, MD, President and CEO of MELA Sciences. "Today's dialog was very constructive and we hope it will have a positive impact on improving transparency and efficiency within the agency, especially for medical device companies that aim to achieve robust clinical outcomes based on evidence-based strategies. In our case, we pursued the highly rigorous Premarket Approval Application (PMA) route for MelaFind, and conducted the largest prospective study to-date in melanoma detection. We are encouraged that today's hearing, as well as comments made by Center for Devices and Radiologic Health (CDRH) Director Dr. Jeffrey Shuren, will help facilitate a timely and transparent review of the MelaFind PMA application and PMA amendment."

"It's our belief that the FDA, the Congress and MELA Sciences all believe in the same things: scientific excellence and creative medical products that offer ways to reduce health care costs and save lives," Gulfo added.

Mandel recently wrote a paper for the PPI highlighting the extended MelaFind approval pathway. His paper is titled, "Is the FDA Strangling Innovation?" and is available on PPI's website (http://progressivefix.com/wp-content/uploads/2011/06/06.2011-Mandel_How-the-FDA-Impedes-Innovation1.pdf).

The subcommittee, which is led by Rep. Cliff Stearns (R-Fla.), is responsible for oversight of agencies, departments and programs within the jurisdiction of the House Energy & Commerce Committee, including the FDA and the Centers for Medicare & Medicaid Services.

About MELA Sciences, Inc:
MELA Sciences is a medical technology company focused on developing MelaFind®, a non-invasive and objective multi-spectral computer vision system intended to aid in the detection of early melanoma. MELA Sciences designed MelaFind® to assist in the evaluation of clinically atypical pigmented skin lesions, when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma. MelaFind® acquires and displays multi-spectral (from blue to near infrared) and reconstructed RGB 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, the deadliest form of skin cancer. Although no cure is currently available for advanced-stage melanoma, melanoma is virtually 100% curable if caught early.

MelaFind® Proposed Indications for Use
MELA Sciences proposes that MelaFind® is indicated for the evaluation of clinically atypical cutaneous pigmented lesions (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 mm, evolving, patient concern, regression, and "ugly duckling"), when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma. MelaFind® is a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early (e.g., non-ulcerated, not bleeding, or less than 2.2 cm in diameter) melanoma.

MelaFind® is not a screening device and is not indicated for non-pigmented lesions, banal pigmented lesions, lesions that are clinically identified as definite melanomas, or lesions on special anatomical sites (i.e., acral, mucosal, subungual).

Regulatory Status
The MelaFind® Pre-Market Approval (PMA) application was filed with the FDA in June 2009, received positive FDA Advisory Panel recommendations in November 2010 and is currently under review at the FDA. In February 2011, the Company filed an amendment to the MelaFind® PMA application with the FDA, limiting the indication for use to dermatologists. 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.

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," "assumes," "predicts" 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 known and unknown 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 financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties facing the company such as those set forth in its reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (the "SEC"). Factors that might cause such a difference include whether the data from our pre-clinical studies and clinical trials is sufficient to support regulatory approval of MelaFind®, whether we are required to provide the FDA with additional data or perform additional testing on MelaFind® or, even if we do receive regulatory approval, whether any such approval is for the indications we seek. Given the uncertainties affecting companies in the medical device industry such as the company, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. The company urges you to carefully review and consider the disclosures found in its filings with the SEC which are available at www.sec.gov and www.melasciences.com.

Contact Information

  • For more information contact
    MELA Sciences
    646-871-8485