ChitogenX Inc. announced that it has concluded enrolment at 20 subjects in its U.S. multi-site rotator cuff tear repair phase I/II clinical trial entitled: A Blinded, Randomized Controlled Study Investigating the Safety of Ortho-R® for Rotator Cuff Repair Compared with Standard of Care: ORT-2020-01 (Ortho-R® Study). All study activities will be completed by June 2024 as per the clinical trial protocol following completion of the clinical follow-up and safety analysis for the 20 recruited subjects. Study results are expected during the summer of 2024.

ChitogenX is grateful to the sites and subjects for their contribution to this important clinical trial. Thus far, there have been no safety issues reported with every subject having been treated between 3 and 12 months. The original U.S. Phase I/II clinical trial protocol was for a blinded, randomized controlled study investigating the safety of ORTHO-R® for rotator cuff tear repair compared with standard of care in a total of 78 subjects at ten clinical sites throughout the U.S. The return on the investment required to complete the full recruitment of the trial is difficult to justify based on the little incremental benefit expected statistically.