Medical Device Daily
BioMimetic Therapeutics (Franklin, Tennessee) reported it 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, which will be in Canada, is expected to include enrollment of up to 30 patients.
The company said that the 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. It 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.
The trial is designed as a multi-center, randomized (2:1), controlled, blinded study to evaluate safety and performance of Augment Rotator Cuff for primary surgical treatment of full thickness (= 2 cm to < 5 cm) rotator cuff tears.
The Canadian study is expected to enroll up to 30 patients with 20 patients receiving Augment Rotator Cuff 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 2Q11.
“What we would look to do is take this data back to the U.S. to support a larger trial in the states,“ Hans Kestler, VP of Sports Medicine for BioMimetic told Medical Device Daily. “If we're able to demonstrate safety [in the trial in Canada], then we would be looking at starting a trial in the U.S. in the second half of 2012.“
Rotator cuff tear is a common cause of pain and disability among adults. Most tears occur in the supraspinatus tendon, but other parts of the cuff may be involved. Rotator cuff tears are among the most common shoulder injuries, and rotator cuff repair is one of the most commonly performed orthopedic soft tissue procedures performed in the U.S.
The company said its primary market for the product would come not only from those active in sports but also an aging population dealing with the degeneration of rotator cuffs.
“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 Samuel Lynch, president/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.“
In 2005, BioMimetic received marketing approval from the FDA for its first product, GEM 21S, as a grafting material for bone and periodontal regeneration.
Additionally, BioMimetic Therapeutics has completed and continues to sponsor clinical trials with its three lead product candidates Augment Bone Graft, Augment Injectable Bone Graft, and Augment Rotator Cuff Graft in multiple orthopedic indications including the treatment of foot and ankle fusions, the stimulation of healing of fractures of the wrist, and the surgical treatment of rotator cuff tears. In November 2009, BioMimetic received approval from Health Canada to begin marketing Augment Bone Graft as an alternative to the use of autograft, the current gold standard in bone grafting, in foot and ankle fusion indications.
BioMimetic focuses on using purified recombinant human platelet-derived growth factor (rhPDGF-BB) in combination with tissue specific matrices as its primary technology platform for promotion of tissue healing and regeneration. It was founded in 2001 and it went public in 2006. The firm employs nearly 100 people.
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