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Wright subsidiary receives FDA approval letter for bone graft offering
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Wright Medical Group recently announced its subsidiary, BioMimetic, received an approvable letter in its premarket approval application from the FDA for the company’s Augment Bone Graft.
Indicating the product to be a safe and effective alternative to autograft in ankle or hindfoot fusions, the letter states the company’s bone graft is approvable, pending normal inspections of BioMimetic’s facilities.
Pending approval, the bone graft would be the first clinically proven protein therapeutic in the domestic orthopedic market in more than a decade, according to a press release from Wright.
The Augment Bone Graft utilizes recombinant human platelet-derived growth factor to initiate biological stimulus of osteoblasts and beta-tricalcium phosphate to support bone growth.
“Augment will provide clear benefits to patients and physicians and is expected to be a significant catalyst and meaningful new future growth driver for our business,” Robert Palmisano, president and CEO of Wright Medical, said in the release. “We will work swiftly to address the inspection requirements set forth in the approvable letter and expect our U.S. foot and ankle commercial team to be ready to launch immediately upon final approval.”