Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, is pleased to announce the full commercial launch of PRO-STIM™ Injectable Inductive Graft. PRO-STIM™ graft is a novel composite grafting material that is injected through a small needle or digitally implanted, 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 (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 Wright's pivotal pre-clinical testing, PRO-STIM™ graft outperformed autograft bone - long considered the grafting "gold standard" - at 8 weeks.
“This has been a very controlled product release”
"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."
Receiving FDA clearance in September 2009, PRO-STIM™ graft 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," stated Rick Swaim, Director of Wright's Biologics Marketing team. "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 orthopaedic centers, we are confident that PRO-STIM™ graft will deliver results very consistent with our pre-clinical [animal trial] results."
Michael D. Neel, M.D. of mid-south orthopaedic practice OrthoMemphis commented, "PRO-STIM™ graft gives the surgeon a viable alternative to autograft without the complications associated with the donor site. This new, novel option provides a proven, flowable, composite bone graft that adds demineralized bone matrix (DBM) to enhance healing and remodeling into native bone. This hardening material has been useful in my orthopaedic practice for both open and percutaneous applications such as bone cysts and core decompressions of the hip."
"I've used PRO-STIM™ graft in several foot and ankle reconstruction cases to date and have had excellent results," noted Robert D. Santrock, M.D. of Midlands Orthopaedics in Columbia, South Carolina. "The injectability and ease of use allows for simple efficient application and has resulted in good bony fusions in some very challenging patients."
PRO-STIM™ Injectable Inductive Graft will be made available immediately in the U.S. and select international countries through Wright's direct and distributor-based sales force. PRO-STIM™ graft is the latest addition to Wright's Biologics franchise, which includes products such as XPANSION® Micrografting System, PRO-DENSE® Injectable Regenerative Graft, GRAFTJACKET® Regenerative Tissue Matrix, BIOTAPE XM® Reinforcement Matrix, OSTEOSET® T Medicated Bone Graft (not available in the U.S.), and the ALLOPURE® line of foot and ankle bone wedges.
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