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FDA clears Soft Tissue Regeneration’s STR GRAFT

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FDA clears Soft Tissue Regeneration’s STR GRAFT

Soft Tissue Regeneration, an early stage orthopedic device company that has developed a breakthrough tissue engineering platform used to regenerate ligaments and tendons, announced today that it has received FDA clearance to market its STR GRAFT, a biodegradable scaffold used for soft tissue augmentation and rotator cuff repair.

Developed by Cato T. Laurencin , M.D., Ph.D., an orthopedic surgeon and the company’s founder, the STR GRAFT is a three-dimensional 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. Unlike currently available devices, which are made of weaker cadaver or animal tissue that can cause sutures to pull, the STR GRAFT is thinner—about 1 millimeter—and stronger, which lessens pain, speeds recovery time and drastically reduces surgical failure rates.

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