BioMimetic Therapeutics to assess safety, clinical utility of Augment Rotator Cuff Graft

Dec 8 2010

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it initiated enrollment in a pilot clinical trial to assess the safety and clinical utility of Augment^TM 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. 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. Augment Rotator Cuff Graft is an interpositional graft consisting of a collagen matrix hydrated with recombinant human Platelet-Derived Growth Factor-BB (rhPDGF-BB), one of the principal wound healing stimulators in the body. The graft is positioned between the humerus and torn rotator cuff tendon(s) during standard surgical suture repair. BioMimetic is leveraging the same rhPDGF-BB technology around the world for orthopedic applications.

“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”

"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," said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "Over 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 reinjury less likely."