FDA schedules Advisory Panel meeting for review of BioMimetic's Augment Bone Graft PMA.
M2 PHARMA-February 1, 2011-FDA schedules Advisory Panel meeting for review of BioMimetic's Augment Bone Graft PMA(C)2011 M2 COMMUNICATIONS
1 February 2011 - US BioMimetic Therapeutics Inc (NASDAQ: BMTI) said yesterday that the US Food and Drug Administration (FDA) has tentatively scheduled an Orthopedic and Rehabilitation Devices Panel meeting on 12 May 2011 to review the company's Premarket Approval (PMA) application for Augment Bone Graft for the treatment of foot and ankle fusions.
If the panel determines that the product's benefits outweigh any potential risks, the company expects approval of Augment by the FDA within three to six months after the panel date, BioMimetic said.
To date, nearly 650 patients have been treated in Augment orthopedic clinical trials over the past four years, said Dr Samuel Lynch, BioMimetic's president and CEO. Moreover, GEM 21S, a nearly identical product, has proven safe and effective for treatment of periodontal bone and soft tissue defects during its five years of commercial use, added Dr Lynch.
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|Date:||Feb 1, 2011|
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