BioMimetic Aims To Complete Bone Graft Study Enrollment By Year-End
This article was originally published in The Gray Sheet
Executive Summary
BioMimetic Therapeutics is hoping enrollment in an ongoing pivotal trial for its Augment Bone Graft will be complete by year-end despite a recent slowdown in registration
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Research In Brief
BioMimetic bone graft: External fixation supported by BioMimetic Therapeutics' Augment injectable bone graft (formerly branded as GEM OS2) leads to faster bone formation in closed distal radius wrist fractures than external fixation alone, results from a 21-patient pilot study show. The Tennessee company announced Oct. 29 that CT scans by an independent, blinded radiologist showed that 40% of Augment patients in the study had at least 25% bone-fill across the fracture gap three weeks after the procedure, compared to zero control patients. The company notes that the patients in the Augment-treated group were, on average, more osteoporotic (lower bone density) than the control group. As of Oct. 28, the firm had enrolled 314 patients at 34 sites in its North American pivotal trial of Augment in foot and ankle fractures; it expects to complete enrollment of the planned 396-patient trial by early 2009 (1"The Gray Sheet" Aug. 18, 2008, p. 17)
Research In Brief
BioMimetic bone graft: External fixation supported by BioMimetic Therapeutics' Augment injectable bone graft (formerly branded as GEM OS2) leads to faster bone formation in closed distal radius wrist fractures than external fixation alone, results from a 21-patient pilot study show. The Tennessee company announced Oct. 29 that CT scans by an independent, blinded radiologist showed that 40% of Augment patients in the study had at least 25% bone-fill across the fracture gap three weeks after the procedure, compared to zero control patients. The company notes that the patients in the Augment-treated group were, on average, more osteoporotic (lower bone density) than the control group. As of Oct. 28, the firm had enrolled 314 patients at 34 sites in its North American pivotal trial of Augment in foot and ankle fractures; it expects to complete enrollment of the planned 396-patient trial by early 2009 (1"The Gray Sheet" Aug. 18, 2008, p. 17)
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