ChitogenX Inc. announced that it has successfully completed the initial portion of its U.S. Phase I/II ORTHO-R rotator cuff tear repair clinical trial requiring staggered enrolment of 5 patients and Data Safety Monitoring Committee review and sequential clearance for each trial participant. The staggered recruitment phase of the trial required a waiting period of up to a week after each case to allow the Data Safety Monitoring Committee to evaluate whether there was any need to change the protocol or retard trial progress due to any unforeseen safety issues. Company reported that no such issues arose and recruitment at all approved U.S. clinical sites can now proceed simultaneously.

The U.S. Phase I/II clinical trial is 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 patients at ten clinical sites throughout the U.S. Initial safety phase.