Wright Medical (NSDQ:WMGI) said today it won FDA premarket approval for its Augment injectable bone graft.
The bone graft won clearance for the same indications as the Amsterdam-based company’s non-injectable Augment bone graft.
The newly cleared Augment Injectable consists of both recombinant human platelet derived growth factor and a blend of Type I collagen and beta tri-calcium phosphate, the company said.
“In Canada, my colleagues and I have been using Augment Injectable since 2011 based upon its ideal handling characteristics and impressive clinical results. FDA approval of Augment injectable provides a valuable enhancement to the existing Augment product line for U.S. foot and ankle surgeons as a front-line biologic alternative that drives the biological healing process and eliminates the costs and clinical impacts of autograft harvesting,” Dr. Timothy Daniels of Toronto’s St. Michael’s Hospital said in a prepared statement.
Wright Medical said that it is hopeful that the US launch of the Augment Injectable will result in sustained growth in the US for its Augment regenerative solutions platform.
The company added that it is immediately beginning the finalization of its packaging carrying the FDA approved label, and is hopeful it will begin selling the product in the US shortly with a complete rollout in the next four to six weeks.
“Building on the commercial and clinical success of Augment Injectable in the Canadian and Australian markets, this important milestone allows Wright to expand our proven Augment franchise and meet the needs of foot and ankle surgeons in the U.S. with a safe and effective alternative to autograft that includes significantly improved handling characteristics to enable easier and more precise delivery to the fusion site. In addition to the significantly improved handling characteristics with Augment Injectable, one of the key differentiators continues to be the strength of the clinical evidence. Our approved PMA supplement for Augment Injectable builds upon the existing body of evidence supporting the safety and effectiveness of Augment Bone Graft and leverages clinical data from the U.S. and Canada for the injectable formulation,” prez & CEO Robert Palmisano said in a press release.
In early May, Wright Medical posted first-quarter results that topped the consensus estimate on Wall Street and said it won a nearly $31 million dispute with an insurer over its recalled ProFemur hip implant.
