- The FDA approves Wright Medical Group's (NASDAQ:WMGI) Premarket Approval Application (PMA) for its AUGMENT Bone Graft for ankle and/or hindfoot fusion procedures. The company expects the product to generate $10M - 12M in revenue in the first seven to eight months after approval.
- AUGMENT Bone Graft is the first clinically proven protein therapeutic to enter the U.S. orthopedics market in over a decade. The market opportunity is ~$300M per year in the U.S.
- Previously: BioMimetic receives approvable letter from FDA for bone graft therapeutic, lowers 2014 revenue guidance (Oct. 27, 2014)