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

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. "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 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.