Ortho-R is designated as a Drug/Biologic combination product, by the FDA Office for Combination Products. The jurisdictional assignment for Ortho-R will be the Center for Biologics Evaluation and Research (CBER). The news was announced today by Ortho Regenerative Technologies.
On March 26th, 2020, a pre-Request for Designation application was submitted to the FDA’s Office for Combination Products to seek for guidance on designation status for Ortho-R product, a Chitosan-based matrix biopolymer* mixed with Platelet Rich Plasma (PRP) to form an in-situ deliverable biologic implant to augment the repair of Rotator Cuff Tears after standard of care surgery. During the evaluation period, technical, scientific and preclinical information was exchanged with the FDA, and multiple rounds of questions and clarifications were addressed. This substantial information demonstrated that Ortho-R has various physicochemical interacting actions on various cell types and other PRP components, therefore supporting a combination product with the Ortho-R reconstituted in PRP considered a Drug/Biologics that is delivered through accessory Devices.
“We are delighted with the FDA’s Office for Combination Products decision, which is based on scientific facts and will position the company to address a unique leadership opportunity in the orthobiologics market” stated Claude LeDuc, CEO of Ortho RTI. “The orthopedic community is seeking new technologies to improve patients’ outcomes following standard of care surgery procedures in various musculoskeletal soft tissue conditions. With this first regulatory milestone completed, we look forward to working with the CBER jurisdiction of the FDA, focusing on the IND submission during the coming months and completing the preparation work for our planned Rotator Cuff Tear repair US clinical trial.”
*Ortho RTi’s proprietary technology platform is a muco-adhesive CHITOSAN based biopolymer matrix that acts as a biodegradable scaffold with great residency properties to help retain any type of bioactive material, prolong its therapeutic effect and significantly improve benefits to patients. In the case of Ortho-R, it is mixed with the patient’s conditioned plasma of a concentrate of proteins/growth factors (Platelet-Rich Plasma or “PRP”) to deliver biologics to increase the healing rates of occupational and sports-related injuries to tendons, meniscus, ligaments and cartilage. The polymer-biologics hybrid combination 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.