SOURCE: MELA Sciences, Inc.

MELA Sciences, Inc.

July 09, 2012 07:30 ET

MELA Sciences Announces Positive Results of Impact of MelaFind in German Clinical Study

Highly Clinically and Statistically Significant Increases in Melanoma Detection Rates Observed for Dermatologists Incorporating MelaFind Output in Biopsy Decision-Making Process

NEW YORK, NY--(Marketwire - Jul 9, 2012) - MELA Sciences, Inc. (NASDAQ: MELA), the medical device company that has developed MelaFind®, today announced positive results of its study of MelaFind with German dermatologists. The study demonstrated that dermatologists who incorporated MelaFind into their biopsy decision-making process for the detection of melanoma at its earliest, most curable stages outperformed those who did not have the MelaFind information.

The study was conducted in collaboration with the German Cooperative Oncology Group (DeCOG) and German Skin Cancer Society. It included two groups of German dermatologists: Arm 1 with 101 dermatologists who were provided with case histories and clinical and dermoscopic images of more than 100 pigmented skin lesions and Arm 2 with 101 dermatologists who were additionally provided with the MelaFind output for each lesion. The results are summarized in the following table:

            Sensitivity > 90%    
Sensitivity   Specificity   Number of dermatologists   Specificity   Percent of melanomas detected by 90% of dermatologists
Arm 1 - 101 dermatologists with clinical information only   70.5%   54%   3   23%   9.2%
Arm 2 - 101 dermatologists with clinical information & MelaFind result   78.4%   45.1%   22   21%   43%
Statistical significance   p < 0.00001   p < 0.00001   p < 0.00006   Not applicable   p < 0.00002

"The most clinically significant finding is that only 3 dermatologists in Arm 1 (those not provided with the MelaFind information) detected 90% of the melanomas on the study, compared to 22 dermatologists in Arm 2 who incorporated the MelaFind data in their decision-making process, a difference that was highly statistically significant at p < 0.00006," said Dr. Arthur Sober, Professor of Dermatology and Director of Cutaneous Melanoma Program, Harvard University, Massachusetts General Hospital. "Importantly, among those detecting 90% or more of the melanomas specificity was virtually unaffected -- 23% for Arm 1 and 21% for Arm 2."

"Equally clinically compelling was that the proportion of melanomas that at least 90% of the dermatologists chose to excise rose from 9.2% for those dermatologists without the MelaFind information to 43.1% for dermatologists provided with the MelaFind information, which was also highly statistically significant at p < 0.00002," said Andreas Blum, expert study participant and Associate Professor of Dermatology from the University of Tubingen.

"We are thrilled with the results of the German study, the largest study of its kind ever performed, and the impact of MelaFind," said Joseph V. Gulfo, MD, President and CEO of MELA Sciences. "The results are quite consistent with studies performed with dermatologists in the US and will be presented at upcoming national and international meetings in Germany by the principal investigator, Dr. Axel Hauschild, Professor of Dermatology from the University Hospital (UKSH) of Kiel, Germany, including the 23rd Practical Dermatology & Venereology Conference (FoBi) in Munich in July and the 22nd German Skin Cancer Society Meeting of the DeCog (ADO) in September in Hannover."

About MELA Sciences, Inc.
MELA Sciences is a medical device company focused on the commercialization of its flagship product, MelaFind®, and its further design and development. MelaFind is a non-invasive tool to provide additional information to dermatologists during melanoma skin examinations. The device uses light from visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm beneath the skin. The device provides information on a lesion's level of morphologic disorganization to provide additional objective information that may be used by dermatologists in the biopsy decision-making process. MelaFind has been approved by the US Food and Drug Administration for use in the US. In addition, MelaFind has received CE Mark approval and is approved for use in the European Union.

For more information on MELA Sciences, visit

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