Mela Sciences Inc. (Nasdaq: MELA) shares surged 56.9% to $3.52, a day after the developer’s diagnostic device to help detect skin cancer won European Union approval. Volume for the stock topped 4.8 million shares, towering over a daily average of 261,000.
A news release dated September 6 noted that the company, located in Irvington, N.Y., had received CE Mark approval for MelaFind®, allowing the company to market its MelaFind device to dermatologists across the E.U. 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 E.U. The EU is the world’s largest economic bloc with over 500 million residents and annual economic output of over $16 trillion.
The same release quoted CEO Joseph Gulfo as saying, “We’re extremely pleased to receive the CE Mark for MelaFind. With more than 81 million people, Germany represents a significant opportunity for the company and an ideal market to launch MelaFind in the E.U.
Gulfo continued, “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.”
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.