The Company's initial focus in orthopedics is the development of Augment® Bone Graft (rhPDGF/Beta-TCP) as a substitute for autograft in foot and ankle fusions. The final results of a 434 patient randomized controlled trial in the U.S. comparing Augment to autograft were released in July 2010. For the pre-specified primary endpoint, patients treated with Augment experienced a similar fusion rate (61.2%) compared with those receiving autograft (62.0%) at six months. These data met statistical non-inferiority (p=0.037; n=398 patients). The data demonstrated that out of 16 secondary endpoint measures at the 52-week time point, 15 were statistically significant for non-inferiority. Importantly, safety outcomes favored the Augment treatment group, which had fewer complications and infections compared to patients treated with autograft. In May 2011, the FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted favorably on Augment Bone Graft’s safety, efficacy and benefit to risk profile for its use as an alternative to autograft in hindfoot and ankle fusions, and the product is pending a final FDA regulatory decision.
Augment Bone Graft also realized positive results in an 108 patient study in Europe comparing Augment to autograft in foot ankle fusion. This study demonstrated only a seven percent revision rate, which is consistent with the therapeutic failure rate observed in the U.S. pivotal trial for Augment and autograft (7.3-8.0%) and Canadian registration trial (10%), and a safety profile that was consistent with all other studies of Augment to date.
The Company previously received approval to begin marketing Augment as an alternative to the use of autograft in foot and ankle fusion indications in Canada, Australia and New Zealand.
The Company has also closed enrollment in a registration study in Canada to assess the safety and efficacy of Augment Injectable Bone Graft as a substitute for autograft in foot and ankle fusion procedures and initiated enrollment in a North American pivotal study with the same product in hindfoot fusion indications. The injectable formulation will allow delivery of the product to the fusion site through a syringe, ensuring controlled and consistent delivery.
In support of other proposed applications, BioMimetic completed a two cohort pilot study of 21 subjects each, assessing the applicability of Augment® Bone Graft and Augment® Injectable Bone Graft in the repair of distal radius fractures The results of this pilot study suggest that both products showed accelerated healing over normal treatment, which is encouraging for compromised patients who may be at risk for delayed fracture unions.
For many parts of the world, including the EU, BioMimetic is developing Augment for broader indications. The proposed EU indication for Augment and Augment Injectable Bone Grafts includes their use in bony procedures that require supplemental graft material for the repair and regeneration.
In early 2012 the Company released data on a pilot clinical trial in Canada to assess the safety and clinical utility of Augment Rotator Cuff Graft for the repair of large rotator cuff tears. The product achieved its primary safety endpoint, which was evaluated by a comparison of adverse events between the two treatment groups, and no device-related serious adverse events (SAEs) were reported. The results also indicated improvement in the clinical outcome assessments on DASH (Disabilities of Arm, Shoulder and Hand) and WORC (Western Ontario Rotator Cuff) index scores. Augment Rotator Cuff was found to be user-friendly for the surgeons and required no additional operating room or anesthesia time over the current standard of care.
The Company continues to evaluate rhPDGF-BB as a therapeutic for additional sports medicine applications and has released positive pre-clinical data in these areas.
Additionally, in early 2011, the Company released results of its pre-clinical study of interbody lumbar spine fusion. The results demonstrated equivalency between the Augment products as compared to autograft, the current gold standard in spine fusion procedures. In humans, the Augment product candidates used in spine fusion procedures would spare the patient the increased pain and morbidity associated with harvesting autograft.