BioMimetic (BMTI) Announces Trial for Augment Injectable Bone Graft Met Primary Endpoint
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Dr. Timothy Daniels, associate professor of orthopedic surgery at the University of Toronto and St. Michaels Hospital and lead investigator, presented today the results of a Canadian registration study comparing Augment™ Injectable Bone Graft (AIBG) to autograft in foot and ankle fusion surgery. Augment Injectable is an injectable bone graft developed by BioMimetic Therapeutics, Inc. (NASDAQ: BMTI). The presentation took place on Thursday, June 21, 2012, at the American Orthopaedic Foot and Ankle Society (AOFAS) annual meeting. As presented by Dr. Daniels, the trial met its primary endpoint of non-inferiority of AIBG to autograft as assessed by CT scan at six months.
Dr. Daniels reported that assessment of the primary endpoint revealed that 53/63 (84.1%) of the AIBG-treated patients and 100/154 (64.9%) of the autograft-treated patients were fused as determined by six month CT scans (p<0.001). Patients were followed clinically for 52 weeks, at which time 57/63 (90.5%) of the Augment Injectable patients and 120/154 (77.9%) of autograft patients achieved clinical success (p<0.001).
Additionally, patients treated with AIBG were shown to have equivalent functional outcomes with less pain than patients treated with autograft.
No safety concerns were identified, and all Augment Injectable-treated patients were spared the additional risk and morbidity of bone graft harvest.
Dr. Daniels commented on the results of the trial, “Augment Injectable Bone Graft demonstrated at least equivalent, and potentially faster, healing outcomes compared to autograft in this study. I have been impressed with the improved handling and delivery characteristics of Augment Injectable compared to other available bone graft alternatives currently being used. Should Augment Injectable receive Health Canada approval, I believe it will be widely used by surgeons who are interested in sparing patients the additional pain and potential risks associated with traditional autograft bone harvest. Further, given the injectable nature of the material and improved handling characteristics, Augment Injectable may expand the indications for bone grafting.”
The Company expects to file the Device License Application (DLA) for approval of Augment Injectable in Canada this summer.
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Dr. Daniels reported that assessment of the primary endpoint revealed that 53/63 (84.1%) of the AIBG-treated patients and 100/154 (64.9%) of the autograft-treated patients were fused as determined by six month CT scans (p<0.001). Patients were followed clinically for 52 weeks, at which time 57/63 (90.5%) of the Augment Injectable patients and 120/154 (77.9%) of autograft patients achieved clinical success (p<0.001).
Additionally, patients treated with AIBG were shown to have equivalent functional outcomes with less pain than patients treated with autograft.
No safety concerns were identified, and all Augment Injectable-treated patients were spared the additional risk and morbidity of bone graft harvest.
Dr. Daniels commented on the results of the trial, “Augment Injectable Bone Graft demonstrated at least equivalent, and potentially faster, healing outcomes compared to autograft in this study. I have been impressed with the improved handling and delivery characteristics of Augment Injectable compared to other available bone graft alternatives currently being used. Should Augment Injectable receive Health Canada approval, I believe it will be widely used by surgeons who are interested in sparing patients the additional pain and potential risks associated with traditional autograft bone harvest. Further, given the injectable nature of the material and improved handling characteristics, Augment Injectable may expand the indications for bone grafting.”
The Company expects to file the Device License Application (DLA) for approval of Augment Injectable in Canada this summer.
Click here to see the full report.
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