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.