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MELA Sciences Secures Final Investigative Site and Enrolls 100+ Patients for Post-Approval Study for MelaFind(R) System Optical Melanoma Diagnostic Device

Source: The Wall Street Journal, April 2014

MELA Sciences, Inc. , developer of the MelaFind(R) system, an FDA approved optical diagnostic device that assists dermatologists in the diagnosis of melanoma, today announced that it has concluded an agreement with the sixth and final investigative site participating in the Company’s post-approval study (PAS) of the MelaFind(R) system for the diagnosis of melanoma. More than 100 patients have been enrolled in the study to date.

MELA has established six investigative sites, the maximum requirement of the study protocol, at leading healthcare institutions and private practices in Colorado, Florida, Maryland, Massachusetts, New Jersey and Ohio to enroll patients and conduct the study. Those sites and their principal investigators are

Joel Cohen, MD            AboutSkin Dermatology and Derm       Englewood, CO 
                          Surgery, PC 
Armand Cognetta, MD       Dermatology Associates of            Tallahassee, FL 
                          Tallahassee 
Timothy Wang, MD          The Johns Hopkins University         Baltimore, MD 
Arthur Sober, MD          Massachusetts General Hospital       Boston, MA 
Robert Nossa, MD          The Dermatology Group, PC            Verona, NJ 
Meg Gerstenblith, MD      University Hospitals Case            Cleveland, OH 
                          Medical Center

Rose Crane, MELA Sciences’ President and CEO, commented, “We are off to a solid start in our post-approval study, having secured very strong investigative sites led by leading medical dermatologists. I am thankful for the MELA team’s dedication and hard work in initiating and monitoring this study, which I believe will provide us the opportunity to further enhance our technology and the frequency of its use."

The three-year PAS is required in connection with the MelaFind system’s Premarket Approval (PMA) in November 2011 by the U.S. Food and Drug Administration (FDA). The study will report on the safety and effectiveness of the system’s non-invasive, optical imaging and data analysis capabilities in a real-world setting. In April 2014 the FDA approved a revised study timeline to address the slower than anticipated pace of patient recruitment. The study is now identified as “Progress Adequate" according to the current FDA status report.

The PAS protocol anticipates the enrollment of at least 720 patients to accrue the requirement of 78 patients diagnosed with a melanoma or a high-grade lesion. The study involves a two-year follow-up period for each lesion enrolled but not undergoing biopsy. The study is designed to observe dermatologists’ clinical decision-making behavior in a real world setting under conditions where the MelaFind system is and is not available to them. This design will test the primary endpoint hypothesis that the incorporation of the additional MelaFind system information into dermatologists’ clinical assessment results in the identification of more than 110% of the melanomas or high-grade lesions than are identified without data from the MelaFind system. Central histology is the reference standard for disease state.

MELA currently targets submission of the PAS report to the FDA by year-end 2017.

 

 

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