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Wright Medical Group, Inc. announces full commercial launch of osteoinductive bone graft substitute
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Wright Medical Group, Inc., announced today the full commercial launch of its PRO-STIM Injectable Inductive Graft, a novel composite grafting material that is injected through a small needle or digitally implanted, hardens, and is replaced by new bone over time.
In a company press release, Wright Medical Group said, the PRO-STIM graft provides surgeons with the osteoconductive base material (a patented combination of calcium sulfate and calcium phosphate materials), but adds a high volume of osteoinductive demineralized bone matrix (DBM) to the formulation to speed the healing and remodeling process. In pivotal preclinical testing, PRO-STIM graft outperformed autograft bone — long considered the grafting “gold standard” — at 8 weeks.
“Our preclinical 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,” stated Thomas Turner, DVM, 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.”
The PRO-STIM graft received FDA clearance in September 2009 and was released in a controlled fashion to select institutions to confirm human effectiveness over a 13-month period. “This has been a very controlled product release,” Rick Swaim, director of Wright's Biologics Marketing team, stated in the press release. “Extra time and resources were invested in order to generate strong clinical experience prior to our full-scale commercial release. Based on clinical experience in over 600 procedures performed at top orthopedic centers, we are confident that PRO-STIM graft will deliver results very consistent with our pre-clinical [animal trial] results.”