Ortho Regenerative Technologies Partners With PRP Firm for Study

Ortho Regenerative Technologies Inc. has found a partner for its upcoming ORTHO-R rotator cuff tear (RCT) repair study.

The firm did not identify its consort by name, but described it as an “industry-leading global strategic medical company” and said it would provide its proprietary platelet-rich plasma (PRP) system disposable kits to all clinical trial participants, as well as technical training and support. In return, Ortho Regenerative Technologies is giving its partner first dibs on distributing ORTHO-R in combination with its proprietary PRP System.

Ortho Regenerative Technologies’ proprietary RESTORE technology platform is a proprietary muco-adhesive Chitosan-based biopolymer matrix, specifically designed to deliver biologics such as PRP or bone marrow aspirate concentrate (BMAC) to augment and guide the regeneration of new tissue in various musculoskeletal conditions. ORTHO-R is its lead Chitosan-PRP hybrid drug/biologic implant combination product and is designed to increase the healing rates of occupational and sports related injuries to tendons, meniscus and ligaments. Other formulations are being developed for cartilage repair, bone void filling, and osteoarthritis treatment. The proprietary Chitosan-PRP combination ORTHO-R implant can be directly applied into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. 
 
“We are thrilled to have the contribution of an industry-leading player to support our ORTHO-R U.S. clinical trial. Using their platelet concentration systems at all clinical trial sites will create uniformity throughout all study sites and will help maximize our chances of success with our trial,” said, Claude LeDuc, president and CEO of Ortho. “Our ORTHO-R U.S. clinical trial will be one of the first FDA-regulated drug/biologics combination product clinical trial in the orthobiologics field. We are making significant progress with pre-enrollment activities at each respective site. We are confident to start enrolling our first patients during the coming months.
 
During the PRP coagulation and degranulation processes, multiple expressed cytokines such as growth factors contribute to new tissue repair. With its mucoadhesive and stabilizing features, resulting in increasing the biologic activity of PRP, the ORTHO-R/PRP combination product has shown quicker and better tissue repair than the standard of care surgery in a GLP preclinical RCT repair study.
 
The ORTHO-R Phase I/II clinical study is a prospective, randomized, controlled, and blinded clinical trial, to evaluate the safety and efficacy of ORTHO-R as an adjunct to standard of care surgery vs. standard of care surgery alone for rotator cuff tear repair. The clinical trial will enroll 78 patients at 10 clinical sites throughout the United States.
 
Ortho Regenerative Technologies is a clinical stage orthobiologics company developing therapeutic soft tissue repair technologies to dramatically improve the success rate of orthopedic and sports medicine surgeries.