Electro-Optical Sciences files MelaFind PMA application with FDA

Fri. June 05, 2009; Posted: 09:43 AM

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Jun 05, 2009 (Datamonitor via COMTEX) -- MELA | Quote | Chart | News | PowerRating -- Electro-Optical Sciences, a medical technology company, has submitted to the FDA its premarket approval application for MelaFind, a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma.

Positive top line data from the MelaFind pivotal study were announced in February 2009 and subsequently presented at several major international dermatology meetings in March and May 2009, said Electro-Optical Sciences.

The company added that its final analysis of the data demonstrated that for all subgroups analyzed, the sensitivity of MelaFind was greater than 95% and MelaFind specificity was statistically significantly higher than that of study clinicians. The FDA has previously granted expedited review for the MelaFind premarket approval (PMA).

Joseph Gulfo, president and CEO of Electro-Optical Sciences, said: "We believe the final results of the MelaFind pivotal study met the study endpoints and that the pivotal trial satisfied the specifications of the protocol agreement with the FDA under which it was conducted. We look forward to working with the FDA in the review of the MelaFind application."

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For full details on Electro-Optical Sciences Inc (MELA) click here. Electro-Optical Sciences Inc (MELA) has Short Term PowerRatings of 6. Details on Electro-Optical Sciences Inc (MELA) Short Term PowerRatings is available at This Link.

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