FDA clearance for PRO-STIM bone graft substitute

Sep 14 2009

Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, today announced the 510K clearance of PRO-STIM™ Injectable Osteoinductive Bone Graft Substitute. PRO-STIM™ graft is a composite grafting material that is injected through a small needle, hardens, and is replaced by the patient’s new bone over time.

Building on the clinical success of Wright’s PRO-DENSE® material platform, PRO-STIM™ graft provides surgeons with the osteoconductive base material derived from PRO-DENSE® graft (a patent pending combination of calcium sulfate and calcium phosphate materials), but adds a high volume of osteoinductive demineralized bone matrix (DBM) to the formulation. In Wright’s pivotal pre-clinical testing, PRO-STIM™ graft outperformed autograft — long considered the grafting “gold standard” — at 13 weeks.

“Our pre-clinical model showed accelerated healing compared to autograft, suggesting a superiority to autograft that could be very beneficial for human use in the restoration of skeletal or bone defects,” said Thomas Turner, D.V.M., Assistant Professor at Rush University Medical Center in Chicago and principle investigator for the pre-clinical model. “In fact, the new bone repair noted in the PRO-STIM™-treated defects was equivalent, if not better than, normal unoperated bone, indicating fast, efficient remodeling to a more normal state.”

Steven Gitelis, M.D., Vice Chairman-Department of Orthopedic Surgery Rush Medical College in Chicago commented, “In my orthopaedic practice, PRO-DENSE® graft has been my preferred bone substitute for treating contained bone tumors and fractures. PRO-STIM™ graft, which adds osteo-‘inductive’ factors, has proven to be a very potent bone graft substitute in our animal testing. This holds the promise of broader use in bone grafting procedures where purely osteoconductive materials have somewhat limited applicability.”

The FDA clearance will allow Wright’s PRO-STIM™ Osteoinductive Graft to be made available immediately to a limited group of trial centers to validate the pre-clinical findings in clinical use. Following successful clinical use, a full roll-out in the U.S. and select international markets by the second half of 2010 is planned. “The FDA clearance of PRO-STIM™ graft is a meaningful step forward for Wright’s biologics business,” stated Rick Swaim, Wright’s Marketing Director for Biologics. “We believe PRO-STIM™ graft has the potential to significantly expand Wright’s addressable opportunity within the bone graft market, bringing the benefits of PRO-DENSE® graft technology into the larger market segment of procedures that require an osteoinductive material.”

PRO-STIM™ Injectable Osteoinductive Graft is the latest addition to Wright’s biologics franchise, which includes products such as GRAFTJACKET® Regenerative Tissue Matrix, BIOTAPE XM® Reinforcement Matrix, PRO-DENSE® Injectable Regenerative Graft, OSTEOSET® T Medicated Bone Graft (not available for sale in the U.S.), the ALLOMATRIX® line of demineralized bone matrix putties, and the CANCELLO-PURE® line of foot and ankle bone wedges.