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FDA panel backs BioMimetic's Augment

May 12, 2011 11:18 PM UTC

FDA's Orthopedic and Rehabilitation Devices Panel voted Thursday in favor of Augment Bone Graft from BioMimetic Therapeutics Inc. (NASDAQ:BMTI) to treat foot and ankle fractures, despite briefing documents issued on Tuesday that raised concerns about the product's safety and effectiveness. The panel voted 10-8 that the benefits of Augment outweighed its risks as an alternative to autograft. The panel also voted 12-6 and 10-8 that Augment was safe and effective in the indication, respectively. Trading in BioMimetic was halted on Thursday. ...