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Ortho Regenerative Technologies Results from Rotator Cuff Tear Repair Study - Ortho Regenerative Technologies confirmed the safety profile of ORTHO-R biopolymer following completion of a pivotal preclinical study in rotator cuff tear repair. Results confirmed the safety profile of ORTHO-R biopolymer as well as statistical significance over standard-of-care (sutures and anchors) alone. Ortho RTI has completed two studies in large animals, namely, a pilot study with 18 sheep with MRI data collected at 6 weeks and 3 months and histopathology at 3 months, then, a pivotal study with 48 sheep collecting MRI data at 3 and 6 months and histopathology at 6 months. Treatment with anchors and sutures was compared to standard of care plus ORTHO-R muco-adhesive orthobiologic hybrid implant.mPilot and pivotal studies demonstrated a decrease in tendon gap at 3 months in ORTHO-R treated groups vs. standard of care control groups. A decreased tendon gap is indicative of faster restauration of tissue structure. In both studies, results at 3 months and 6 months showed equivalent safety. Ortho RTI's platform acts as a biodegradable scaffold that retains any type of bioactive material, prolonging its therapeutic effect and improving benefits to patients. Ortho-R is mixed with Platelet-Rich Plasma to deliver biologics that can increase the healing rates of occupational and sports related injuries to tendons, meniscus, ligaments and cartilage. The polymer/biologics combination can be directly applied to the site of injury during a routine operative procedure without significantly extending the time of the surgery and without further intervention.
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