FDA, Clinical Trial News: AtriCure, Generex Biotech, MELA Sciences

After the market close on Monday, AtriCure (NASDAQ:ATRC) announced that it received conditional FDA clearance to conduct a clinical trial that to evaluate the Company’s minimally invasive surgical ablation product platform in conjunction with Biosense Webster THERMOCOOL catheter ablation in the treatment of an abnormal heart rhythm known as atrial fibrillation (AF). The feasibility study is expected to begin in the latter half of the year and will enroll 30 patients at five US medical centers.

Generex Biotech (NASDAQ:GNBT) announced yesterday that it has enrolled over 400 subjects in its pivotal Phase 3 clinical trial for Generex Oral-lyn, which is a novel formulation of insulin with a unique spray delivery mechanism for absorption through the cheeks. GNBT expects the first interim analysis in this study to occur in approximately two months, which may trigger an end of study treatment period by year-end to support its planned NDA submission for the product.

MELA Sciences (NASDAQ:MELA) submitted its quarterly SEC 10-Q filing on Monday, indicating that the Company filed its final formal response on 5/7/10 in response to questions received from the FDA in late March regarding a Pre-Market Approval (PMA) submission filed in June 2009, which is seeking marketing clearance for MelaFind as a non-invasive computer vision system to aid in the early detection of melanoma. MELA has recently provided guidance for possible CE Mark clearance during 1Q11 to market MelaFind in Europe.

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