Ortho Regenerative Technologies Inc, a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, announced that it has received a clinical hold letter from the U.S. FDA related to its Investigational New Drug (IND).

Ortho had submitted an 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.

The FDA has requested additional Chemistry, Manufacturing, and Control ("CMC") related information. The Company is confident in its ability to address and provide the FDA with the required information and testing data over the coming four to six weeks.

"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."