Early this morning, Electro-Optical Sciences, Inc. announced positive top-line results of its pivotal trial of MelaFind, a non-invasive, point-of-care instrument to assist in the early detection of melanoma, the deadliest form of skin cancer. The blinded study was conducted at seven centers across the US and included 1,831 pigmented skin lesions from 1,383 patients, making it the largest prospective study ever conducted in melanoma detection. The company is currently completing its Pre-Market Approval (PMA) application and anticipates filing it with the US Food and Drug Administration (FDA) in the near future.
“MelaFind appears to be an excellent tool to help detect melanoma at the earliest, most treatable stage,” stated Gary D. Monheit, MD, Associate Clinical Professor of Dermatology at the University of Alabama in Birmingham and the lead investigator for the MelaFind pivotal trial. “With no cure for late stage melanoma, early detection is our best defense against this cancer, which has reached epidemic proportions.”
According to the press release, MelaFind detected 112 of 114 (98% sensitivity; lower confidence bound of 95%) melanomas that were eligible and evaluable for primary sensitivity endpoint analysis, and 125 of 127 (98% sensitivity; lower confidence bound greater than 95%) melanomas overall. Nearly 50% of the melanomas in the study were melanoma in situ, the most curable yet most difficult form of melanoma to detect.
Joseph V. Gulfo, MD, President and CEO of EOS, said, “We are extremely pleased with the outcome of the pivotal study and are now focused on completing our PMA to submit to the FDA as quickly as possible. Our mission with MelaFind has always been to provide a useful tool to aid in detecting melanoma at its earliest, most curable stage. We look forward to discussing these data with the agency.”
The company’s stock is currently trading at $6.33, up 79.32% from yesterday’s close. 1,119,762 shares have traded so far this morning as compared to a 3 month average daily volume of 65,625.
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