Company confident of providing requested information over the coming weeks Phase I/II clinical trial preparation activities to continue in preparation of anticipated IND approval. MONTREAL, June 4, 2021 /PRNewswire/ - Ortho" or the " Company"), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced that it has received a clinical hold letter from the U.S. Food and Drug Administration ("FDA") related to its Investigational New Drug (IND) application to begin a phase I/II clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to standard of care surgery in rotator cuff tear repair.