Ortho Regenerative Technologies Inc (CSE:ORTH) announced that it has begun the enrollment of patients after the first patient surgery was completed in its US phase I/II clinical trial of rotator cuff tear repair.
The first patient surgery was successfully completed at the Tucson Orthopaedic Institute in Tucson, Arizona, it said. The clinical trial will enroll 78 patients at 10 clinical sites throughout the US.
The ORTHO-R phase I/II clinical study is a prospective, randomized, controlled, and blinded clinical trial, to evaluate the safety and efficacy of its ORTHO-R soft tissue repair platform as an adjunct to standard of care surgery versus standard of care surgery alone for rotator cuff tear repair.
"The enrollment of our first patient in the US Phase I/II rotator cuff tear repair clinical trial is our most significant clinical milestone to date,” Philippe Deschamps, CEO of Ortho Regenerative said in a statement.
READ: Ortho Regenerative Technologies highlights milestones achieved in 1Q ended April 30, 2022
“With eight centers now actively screening for patients and enrollment of additional patients already scheduled over the coming weeks, completion of the phase I safety portion of the clinical program is now expected by the end of September should our enrolment estimates be confirmed," Deschamps added.
Ortho Regenerative Technologies is a clinical-stage orthobiologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of orthopedic and sports medicine surgeries.
ORTHO-R, the company’s lead Chitosan-Platelet-Rich Plasma (PRP) hybrid drug/biologic implant combination product, is formulated and designed to increase the healing rates of occupational and sports-related injuries to tendons, meniscus and ligaments.
Contact the author at jon.hopkins@proactiveinvestors.com