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BioMimetic Therapeutics Inc. initiates rotator cuff graft trial
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BioMimetic Therapeutics, Inc. announced it has initiated enrollment in a pilot clinical trial to assess the safety and clinical utility of Augment Rotator Cuff Graft for the repair of large rotator cuff tears. The randomized, controlled pilot trial is expected to include enrollment of up to 30 patients, according to a company press release.
BioMimetic said the study’s objective is to determine the safety and performance of Augment Rotator Cuff (ARC) Graft for primary surgical treatment of full-thickness rotator cuff tears. The ARC graft is an interpositional graft consisting of a collagen matrix hydrated with recombinant human platelet-derived growth factor-BB (rhPDGF-BB). The graft is positioned between the humerus and torn rotator cuff tendon(s) during standard surgical suture repair.
"This is a key development milestone for BioMimetic, as this trial represents the first use of our rhPDGF-BB platform technology directed at improving the healing of tendons and ligaments in humans,” Samuel Lynch, DMD, DMSc, president and CEO of BioMimetic Therapeutics, stated in the release. “[More than] 450,000 people have rotator cuff tears surgically repaired in the U.S. every year, and it has been reported that up to half of these patients could experience retears or incomplete healing. Currently there are no approved recombinant therapies for facilitating the repair of tendons after injury. Based on our preclinical studies, we believe Augment Rotator Cuff has the potential to speed healing, thus shortening recovery and facilitating faster return to sport and other activity and making re-injury less likely.”
The trial is designed as a multi-center, randomized (2:1), controlled, blinded study to evaluate safety and performance of ARC for primary surgical treatment of full-thickness, between 2 cm and 5 cm, rotator cuff tears. The Canadian study is expected to enroll up to 30 patients with 20 patients receiving ARC plus standard suture repair and 10 patients receiving standard suture repair alone. The primary endpoint of the trial is safety, which will be evaluated by a comparison of adverse events between the two groups. MRIs will also be reviewed to evaluate the safety and durability of the device. The company anticipates completing enrollment in the second half of 2011.