Ortho Regenerative Technologies (Ortho RTI) has submitted an Investigational New Drug application to FDA for the initiation of a Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair. Enrollment is expected to start in 2Q21.
The prospective, randomized, controlled and blinded U.S. study will examine ORTHO-R combined with standard of care surgery vs. standard of care surgery alone. The trial will enroll 78 patients at six to 10 clinical sites.
ORTHO-R proprietary biopolymer technology has been designed to increase the healing rates of sports related injuries to tendons, meniscus, ligaments and cartilage. It can be placed directly into the injury site during a routine surgical procedure without significantly extending the length of the surgery and without further intervention.
Claude LeDuc, President and CEO of Ortho RTI, said, "There is a clear need for improved rotator cuff tear repair treatments, as estimates have put the re-tear (or non healing) rate at an average of 50%. With more than 600,000 patients undergoing rotator cuff surgery every year in the U.S., this represents an enormous commercial opportunity, and as demonstrated in 2020 by our GLP preclinical program results, we strongly believe that ORTHO-R can help address these significant unmet needs and meaningfully improve the success rate of these surgeries."