Wright Medical Group, Inc. Announces FDA Clearance for PRO-STIM(TM) Osteoinductive Bone Graft Substitute

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ARLINGTON, Tenn.–(BUSINESS WIRE)–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.”

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