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The blinded pivotal trial, which will serve as the basis for the company's pre-market approval (PMA) application with the FDA, was conducted at seven centers in the US.
Investigators used the MelaFind system to evaluate over 1,800 suspicious lesions from over 1,300 patients. All the suspicious lesions were subsequently biopsied and sent for dermatohistopathologic analysis. Results of the pivotal trial are anticipated in the fourth quarter of 2008, with PMA filing to follow.
Joseph Gulfo, president and CEO of Electro-Optical Sciences (EOS), said: "This represents a significant milestone for the company in our quest to improve early melanoma detection."
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