Mela Science's Skin Cancer Detector Approved in EU
Shares of Mela Sciences (NASDAQ:MELA) jumped nearly 70% on Wednesday after the medical device maker said its melanoma detector was approved for use in the European Union, lifting hopes that it will have the same success in the U.S.
Mela said it will first market the device, called MelaFind, for dermatologists in Germany, which has the highest incidence of melanoma in Europe with rates for the skin cancer doubling over the last decade.
With more than 81 million people, Germany represents a significant opportunity for the company and an ideal market to launch MelaFind in the EU, said Mela CEO Joseph Gulfo.
To achieve initial goals for the devices launch and commercial development, the Irvington, N.Y.-based company said it will utilize a direct sales force that focuses on strategically placing MelaFind systems in the top dermatology practices in several key cities throughout Germany.
The speedy approval in Europe, the application was submitted earlier this summer, allows the device to be marketed freely across the 27 states of the EU, the worlds largest economic bloc with more than 500 million residents.
Mela, which submitted an application for MelaFind in the U.S. more than two years ago, still awaits a decision from the Food and Drug Administration.
However, a positive vote from the General and Plastic Surgery Devices Panel in 2010, which the U.S. agency has been known to follow closely, coupled with the rapid approval in Europe, has risen hopes the device will achieve approval in the U.S.
The study used to support the device involved 1,383 patients, the largest of its kind, in which the device demonstrated 98% sensitivity to the disease during the trial, compared with dermatologists that had just 72% sensitivity.