Where is the MELA Sciences thread? Stock is up 78% AH...

Discussion in 'Stocks' started by ASusilovic, Sep 7, 2011.

  1. MELA Sciences Receives European Union Approval for MelaFind(R)

    RVINGTON, NY--(Marketwire -09/06/11)- MELA Sciences (NASDAQ: MELA - News) today announced that it received CE Mark approval for MelaFind®, allowing the company to market its MelaFind device to dermatologists across the European Union (EU). The company intends to initially market MelaFind in Germany, which has the highest incidence of melanoma in Europe.

    The CE (Conformité Européenne, or "European Conformity") Mark approval allows the company to market MelaFind freely across the 27 nations that comprise the EU. The EU is the world's largest economic bloc with over 500 million residents and annual economic output of over $16 trillion.

    "We're extremely pleased to receive the CE Mark for MelaFind," said Joseph V. Gulfo, MD, President and CEO, MELA Sciences. "With more than 81 million people, Germany represents a significant opportunity for the company and an ideal market to launch MelaFind in the EU. Given the high rates of melanoma seen in the German population, we believe MelaFind has the potential to make a deep impact on the disease there. In order to achieve our initial goals for the commercial development phase of the launch, we plan to utilize a direct sales force that will focus on strategically placing MelaFind systems in the top dermatology practices in several key cities throughout the country."

    Melanoma rates in Germany have doubled over the last decade and the national mortality rate from the disease is the highest in Europe. Over 20,000 Germans are expected to be diagnosed with melanoma by 2016. Germany is the only country in the world with a nationwide skin screening effort in place for men and women age 35 and older.

    The clinical data for the CE Mark application were submitted in May 2011 and the complete technical file was submitted in early July 2011.

    "We are very impressed with the process in obtaining EU regulatory approval, which included an extensive audit of our facilities," said Dr. Gulfo. "We enjoyed frequent, straightforward and transparent interactions with European reviewers leading up to application submission and throughout the review process."

    The studies used to support the CE Mark application were the 1,383-patient U.S. pivotal trial and the companion reader study of 110 dermatologists: the device demonstrated a 98% sensitivity; whereas dermatologists had a 72% sensitivity in the companion reader study. MELA Sciences worked with the U.S. Food and Drug Administration (FDA) to design the pivotal study, the largest ever conducted in melanoma detection, and has a Binding Protocol Agreement with the FDA. Approximately 11% of all lesions and melanomas in the MelaFind database were obtained from European clinical sites.

    In the U.S., MELA Sciences submitted a PMA application for MelaFind in June 2009, and received a positive vote from the General and Plastic Surgery Devices Panel at an advisory committee meeting in November 2010. The company is currently awaiting the FDA's decision.