BioMimetic (BMTI) Receives Approval From Health Canadato Market Augment
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that it has received approval from Health Canada to begin the marketing of its lead orthopedic product, Augment Bone Graft, as an alternative to the use of autograft in midfoot, hindfoot and ankle fusion indications in Canada.
Augment is a completely synthetic grafting system for bone regeneration and is composed of a purified recombinant growth factor, recombinant human platelet derived growth factor (rhPDGF-BB), and a synthetic calcium phosphate matrix, beta-tricalcium phosphate (b-TCP). The combination of the two components of Augment is key to the overall effectiveness of the product. The rhPDGF-BB provides the biological stimulus for tissue repair by stimulating the recruitment and proliferation of new bone forming cells and blood vessels, while the b-TCP provides the framework or scaffold for new bone growth to occur.
Health Canada approval of Augment was based on results from a three center, 60 patient open label trial in which all individuals were treated with Augment. Patients were studied for nine months following implantation of the product and were assessed for healing using clinical and radiographic endpoints. Patients requiring fusions involving the midfoot, hindfoot and ankle were all eligible for enrollment in the study.
The results of the study demonstrated that 90% of the patients, which included a large percentage of high risk individuals, achieved a successful outcome based upon return to full weight-bearing and lack of need for revision surgery. The radiographic fusion rate was 87% at nine months after surgery. Based on a literature meta-analysis, the high level of success achieved in the study is consistent with results expected using autograft, the current gold standard for bone grafting materials, but without the morbidity and extra operating room time required to harvest autograft. The data from GEM 21S showing periodontal bone regeneration was also included as supplementary information demonstrating that the product does re-grow bone.
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