Ortho Regenerative Technologies received a clinical hold letter from FDA related to its Investigational New Drug application to begin a Phase I/II clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to surgery in rotator cuff tear repair.
FDA has requested additional Chemistry, Manufacturing, and Control-related information.
"We appreciate the FDA's guidance and assistance to Ortho, in the development of a first-in-class orthobiologics combination product to improve outcomes of standard of care surgery in rotator cuff tear repair," said Claude LeDuc, President and Chief Executive Officer of Ortho. "We will work diligently to address the FDA's questions as quickly as possible and look forward to continuing to work closely with them to secure IND approval. In parallel, we will continue working on our Phase I/II clinical trial preparation activities to ensure we minimize the impact on our overall timelines."