U.S. IND CLINICAL HOLD LIFTED BY THE FDA MONTREAL, Dec. 13, 2021 /PRNewswire/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTCQB: ORTIF) ("Ortho" or the "Company"), a clinical-stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, announced today that the clinical hold on its U.S. Investigational New Drug ("IND") application has been lifted by the U.S. Food and Drug Administration ("FDA") and that the Company is cleared to proceed with its Phase I/II U.S clinical trial to evaluate the safety and efficacy of ORTHO-R as an adjunct treatment to standard of care surgery in rotator cuff tear repair. By lifting the clinical hold, the FDA confirms that Ortho has satisfactorily addressed all issues related to the August 16, 2021, clinical hold letter.
"We are delighted to have reached this critical regulatory milestone, and we are grateful for the FDA's productive guidance and collaboration" said Claude LeDuc, President and CEO of Ortho. "Achieving this green-light to begin our clinical study is the result of committed efforts from the ORTHO team, which includes Polytechnique Montreal's Biomaterial and Cartilage Laboratory scientific team, MCRA's regulatory and clinical team, and our manufacturing and analytical partners."
"We can now proceed with our Phase I/II U.S. clinical trial", said Claude LeDuc. "There is a clear and significant unmet medical need to improve the success rate of orthopedic and sports medicine soft-tissue surgeries. ORTHO-R is a unique FDA-designated Drug/Biologic Combination Product, offered as a tissue-regeneration novel solution for soft tissue repair. The physicochemical configuration of the drug interacts with Platelet-Rich Plasma's (PRP) biological elements, including expressed growth factors. In preclinical studies, it results in enhanced and sustained biological activity that has shown faster and better tissue repair."
The Phase I/II clinical trial will enroll 78 patients at ten clinical sites throughout the U.S. Ortho will now advance to Institutional Review Board (IRB) filings for each selected clinical site to enable patient enrollment. The ORTHO-R Phase I/II study is a prospective, randomized, controlled, and blinded clinical trial.