The Food and Drug Administration's Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted 12-6 in favor of recommending support for BioMimetic Therapeutics' Augment Bone Graft, according to a company news release.
The panel recommends the FDA approve the Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusions. The panel also voted 10-8 that Augment demonstrates a favorable benefit to risk profile for the indication.
The FDA will consider these recommendations when completing its review of the company's premarket approval application. The product has Level 1 data supporting its safety and efficacy as a fully synthetic bone growth factor replacement for autograft.
Read the report on the advisory committee's vote.
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The panel recommends the FDA approve the Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusions. The panel also voted 10-8 that Augment demonstrates a favorable benefit to risk profile for the indication.
The FDA will consider these recommendations when completing its review of the company's premarket approval application. The product has Level 1 data supporting its safety and efficacy as a fully synthetic bone growth factor replacement for autograft.
Read the report on the advisory committee's vote.
Related Articles on BioMimetic:
BioMimetic Therapeutics Posts $8M Net Loss in Q1
Millennium Research Group: Bone Graft Substitute Market to Reach $2.3B by 2015
FDA to Review Premarket Approval Application for BioMimetic