New Haven, Conn.-based Soft Tissues Regeneration (STR), an early-stage orthopedic device company that has developed a tissue engineering platform used to regenerate ligaments and tendons, has received U.S. Food and Drug Administration (FDA) clearance to market its STR graft, a biodegradable scaffold used for soft tissue augmentation and rotator cuff repair.
The scaffold was developed by Cato T. Laurencin, M.D., Ph.D., orthopedic surgeon and founder of STR. The graft is a 3-D braided engineered matrix that Laurencin likens to a patch. During surgery, surgeons can drape this biodegradable patch over the tendon that sits on the shoulder bone, anchoring it with sutures to keep it in place while the tendon, bones and nearby tissues heal. Currently available devices are made of cadaver or animal tissue that can cause sutures to pull, while the STR Graft is thinner (about 1 millimeter) and reportedly stronger. STR claims these properties lessens pain, speeds recovery time, and drastically reduces surgical failure rates.
Rotator cuff tears are a common cause of pain and disability among adults. According to the American Academy of Orthopaedic Surgeons, in 2008, close to 2 million people in the United States saw their doctor because of a rotator cuff problem. Surgeries, however, are not always successful. According to Laurencin, depending on the size of the tear, the degree of muscle atrophy, the quality of the tendon, and the post-op rehabilitation protocol, repeat surgeries are necessary 20 percent to 70 percent of the time.
“There are several products available to augment rotator cuff repair, but they suffer from strength, suture pull-through and surgical deployment issues, all of which the STR graft addresses,” said Laurencin.
STR’s device has undergone several successful pre-clinical studies and extensive mechanical and other testing over the past two and a half years of development. The company expects to commercialize the graft by 2014.