The FDA just granted Wright Medical Group N.V. premarket approval (PMA) for its Augment Injectable Bone Graft which features a recombinant human platelet derived growth factor (rhPDGF).
The company originally received PMA approval for the bone graft in 2015 after a torturous route through the approval process. More on that later.
This injectable version of Augment has the same clinical indications as the original bone graft.
Augment Injectable combines recombinant human platelet derived growth factor (rhPDGF-BB) with a blend of Type I collagen and Beta tri-calcium phosphate, which the company says, “provides a clinically proven and safe and effective alternative to autograft for use in hindfoot and ankle fusion in an easy to use flowable formulation.”
Robert Palmisano, president and chief executive officer of Wright, said the injectable version of the bond graft, “includes significantly improved handling characteristics to enable easier and more precise delivery to the fusion site.” He added that one of the key differentiators continues to be the strength of the clinical evidence from the U.S. and Canada.
The company will immediately start the process of finalizing its packaging carrying the FDA approved labeling and expects to begin selling product in the U.S. shortly and complete the rollout in the next four to six weeks.
Timothy Daniels, M.D., chief of the Division of Orthopaedic Surgery of St. Michael’s Hospital and Professor at the University of Toronto in the Department of Surgery, said he and his colleagues in Canada have been using the injectable graft since 2011, “based upon its ideal handling characteristics and impressive clinical results.”
Market Opportunity
According to the company, the injectable version is the first clinically proven injectable protein therapeutic to come to the U.S. orthopedic market offering an alternative to autograft in ankle and/or hindfoot fusion procedures. The company says the FDA approval translates into an estimated market opportunity of approximately $300 million in the U.S.
Torturous Approval Gauntlet
Getting FDA approval wasn’t an easy process after Wright paid $380 million for BioMimetic in 2013.
There was a very contentious FDA orthopedic panel meeting and vote in 2011 and then an 18-page “not approvable” letter from the FDA in 2013 which said the company would have to perform a new clinical study. Finally, in 2014, after filing an appeal with the agency’s Dispute Resolution Panel, the company and FDA’s Office of Device Evaluation (ODE) reached an agreement whereby the agency would accept an amendment to the company’s PMA application.
After the amended PMA was submitted, the agency finally approved Augment.
At the time of the original approval, Needham & Company, LLC analyst Mike Matson wrote that there was a potential for Augment to be used off-label in other extremities procedures and even other orthopedic procedures such as in spine and trauma. But given Medtronic plc’s issues with Infuse (the last biologic approved by the FDA at the time), Matson said he thought that it was in Wright Medical’s interest to try to do what it can to prevent off-label use.
