FRANKLIN, Tenn.–(BUSINESS WIRE)–BioMimetic Therapeutics, Inc. (NASDAQ: BMTI – News) today announced positive top-line results from its North American pivotal (Phase III) randomized controlled trial comparing its fully synthetic, off-the-shelf bone growth factor product, Augment Bone Graft (“Augment”), to autograft for use in hindfoot and ankle fusion surgery. The primary study goal was to establish non-inferiority of Augment compared to autograft. Autograft is the historical standard of care but has the limitation that it must be obtained and transplanted from another bone in the patient’s body, often requiring a second surgical procedure. These positive top-line results indicate that, with the use of Augment, patients can expect a comparable treatment outcome while being spared the pain and potential morbidity associated with traditional autograft bone harvesting and transplantation.
For the primary endpoint, the percent of subjects achieving fusion as defined by 50% or greater bone bridging on CT scans at 24 weeks, patients treated with Augment experienced a similar fusion rate (61.2%) compared with those receiving autograft (62.0%), which met non-inferiority (p=0.037; n=397 patients). Since many patients had multiple joints treated, analysis was also performed on a per joint basis. Non-inferiority was also established on a per joint basis, with 66.5% of joints treated with Augment fused on CT scans compared to 62.6% of joints treated with autograft (p=<0.001; n=597 joints). In the key clinical, secondary endpoints, the healing (union) rate was 83.1% for Augment compared to 83.9% for autograft at 24 weeks (p=0.008; n=397). The delayed/nonunion rates (lower rates are better) were 8.8% for Augment and 10.2% for autograft (p=0.008). The remaining patients were judged by the investigators to be progressing to healing but were not able to be definitively diagnosed. Infection rates also tended to be lower for Augment (7.3%) compared to autograft (9.5%; p=0.011). Pain at the autograft donor site was present in 95.6% of autograft patients, while Augment patients do not require a donor site. Substantial pain at the autograft donor site (at least 20mm on VAS pain scale) was present at six months in 12.4% of the patients treated with autograft and none of the Augment patients. These findings demonstrate that patients treated with Augment can expect clinical results as good as if they had been treated with autograft, while being spared the pain and potential for additional surgical and post-operative complications resulting from the extra surgical procedure often required to harvest the autograft.