FDA Panel Vote...
Safety? - 12 Yes, 6 No
Efficacy? - 10 Yes, 8 No
Benefits outweigh Risks? - 10 Yes, 8 No
BioMimetic Therapeutics' Augment™ Bone Graft Receives Positive Recommendation from FDA Advisory Committee (press release)
FDA Panel Narrowly Endorses Bone Graft Device (MedicalNews)
FDA Panel Narrowly Votes in Favor of BMTI's Augment (HealthPointCapital)
FDA orthopedic panel favors approval of synthetic bone graft for foot and ankle fusion (OrthoSuperSite)
FDA Agenda & Panel Questions - May 11 (FDA)
http://www.biomimetics.com/
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