Commentary: Shame on the FDA! If you replay the tape here you will find that the FDA approved the study protocol, the company then met the endpoints in the study, the FDA Panel approved it, and then the FDA denied it... and then 4 years later approved it. This irrational behavior spooks the investment community.
Wright Medical Receives FDA Clearance for its Premarket Approval Application of its AUGMENT Bone Graft (HealthPointCapital)
Wright Medical announced that its BioMimetic subsidiary received approval from the FDA for its Premarket Approval Application (PMA) for its AUGMENT Bone Graft, indicated as an alternative to autograft for ankle and/or hindfoot fusion procedures.
AUGMENT is the first clinically proven protein therapeutic (Growth Factor) product to come to the U.S. orthopedics market in over a decade. Growth Factors are a group of soluble proteins that bind onto cell surface receptors, triggering a series of signals that regulate the body’s ability to grow, renew and heal. Presently, there are only two other recombinant growth factors available on the market, Medtronic's INFUSE (indicated for degenerative disc disease in the spine, and lower leg and dental procedures)...
