MCRA was chosen by Ortho Regenerative Technologies (Ortho RTI) as its U.S.-based orthopedic specialty clinical research organization to conduct its Phase I/II human trial of rotator cuff repair with Ortho-R.
The clinical trial will enroll 75 patients, randomized into three arms of 25 patients across multiple sites in the U.S. The disclosure of pivotal preclinical results will occur within 2019, followed by the filing of an Investigational New Drug (IND) application and commencement of a rotator cuff tear repair clinical program in 1Q20.
MCRA, an advisory firm and clinical research organization (CRO) focused on the neuro-musculoskeletal industry, will integrate its regulatory and reimbursement expertise in conjunction with its CRO services for the Ortho-R Phase I/II clinical program.
"The choice of a CRO for our upcoming Phase I/II clinical trial is a key component of our Ortho-R clinical program. It was especially important for us to select a CRO with extensive hands-on orthopaedic experience for biologics and combination products, easy access to top U.S. orthopaedic surgeons, plus expertise in other key areas such as regulatory strategy and submissions," said Claude LeDuc, President and Chief Executive Officer of Ortho RTI. "We expect the coming months to be exciting for Ortho RTI. The disclosure of our pivotal pre-clinical results before the end of 2019, the filing of our IND and the start of a state of the art Rotator Cuff Tear repair clinical program in Q1 2020 should create significant value for our shareholders."