Ortho Regenerative Technologies Inc., a clinical-stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced the initiation of patients’ enrollment following completion of the first patient surgery in its U.S. Phase I/II rotator cuff tear repair clinical trial.
The first patient surgery was successfully completed at the Tucson Orthopaedic Institute in Tucson, Arizona.
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“The enrollment of our first patient in the U.S. Phase I/II rotator cuff tear repair clinical trial is our most significant clinical milestone to date. With 8 centers now actively screening for patients and enrollment of additional patients already scheduled over the coming weeks, completion of the Phase I safety portion of the clinical program is now expected by the end of September should our enrolment estimates be confirmed”, said, Philippe Deschamps, CEO.
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 a total of 78 patients at ten clinical sites throughout the U.S.
Ortho is a clinical stage orthobiologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of orthopedic and sports medicine surgeries. Our proprietary RESTORE technology platform is a proprietary muco-adhesive Chitosan-based biopolymer matrix, specifically designed to deliver biologics such as Platelet-Rich Plasma (PRP) or Bone Marrow Aspirate Concentrate (BMAC), to augment and guide the regeneration of new tissue in various musculoskeletal conditions. ORTHO-R, our lead Chitosan-PRP hybrid drug/biologic implant combination product, is formulated and 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. Considering the significant potential of our technology platform, Ortho continues to assess new therapeutic target uses outside of the soft tissue repair field.