BioMimetic Therapeutics’ Augment™ Bone Graft Receives Positive Recommendation from FDA Advisory Committee
FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI), a biotechnology company specializing in the development and commercialization of innovative bioactive products to promote the healing of musculoskeletal injuries and diseases, announced today that the U.S. Food & Drug Administration’s (FDA) Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted 12-6 in support of the safety of Augment™ Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures. The panel also voted 10-8 in support of the efficacy of Augment for use as an alternative to autograft in hindfoot and ankle fusions. Additionally, the panel voted 10-8 that Augment demonstrates a favorable benefit to risk profile for the same indication. The Company received unanimous support on all three recommendations from the foot and ankle specialists serving on the panel. The advisory committee’s recommendation will be considered by the FDA when completing its review of Augment Bone Graft’s Premarket Approval (PMA) application. Approval of Augment Bone Graft would mark the Company’s entry into the $2.5B U.S. bone grafting market.