Ortho Regenerative Technologies (ORT) entered into a Material Transfer Agreement with an undisclosed medical device company for the exclusive use of their proprietary platelet-rich plasma (PRP) system in ORT’s upcoming Phase I/II U.S. clinical trial of ORTHO-R rotator cuff tear repair.
The company will provide the PRP system disposable kits for all enrolled patients in the study. In return, Ortho has provided the company with a right of first offer to distribute ORTHO-R in alongside their proprietary PRP System.
The ORTHO-R Phase I/II clinical study is a prospective, randomized, controlled and blinded clinical trial, to evaluate ORTHO-R as an adjunct to standard of care surgery vs. standard of care surgery alone for rotator cuff tear repair. The clinical trial will enroll 78 patients at ten clinical sites.
The ORTHO-R/PRP combination product has demonstrated quicker and better tissue repair than the standard of care surgery in a preclinical rotator cuff repair study.
Claude LeDuc, President and CEO, said, “Our ORTHO-R U.S. clinical trial will be one of the first FDA regulated Drug/Biologics combination product clinical trials in the orthobiologics field. We are making significant progress with pre-enrollment activities at each respective site. We are confident to start enrolling our first patients during the coming months.”
Ortho Regenerative Technologies (ORT) entered into a Material Transfer Agreement with an undisclosed medical device company for the exclusive use of their proprietary platelet-rich plasma (PRP) system in ORT's upcoming Phase I/II U.S. clinical trial of ORTHO-R rotator cuff tear repair.
The company will provide the PRP system disposable kits for...
Ortho Regenerative Technologies (ORT) entered into a Material Transfer Agreement with an undisclosed medical device company for the exclusive use of their proprietary platelet-rich plasma (PRP) system in ORT’s upcoming Phase I/II U.S. clinical trial of ORTHO-R rotator cuff tear repair.
The company will provide the PRP system disposable kits for all enrolled patients in the study. In return, Ortho has provided the company with a right of first offer to distribute ORTHO-R in alongside their proprietary PRP System.
The ORTHO-R Phase I/II clinical study is a prospective, randomized, controlled and blinded clinical trial, to evaluate ORTHO-R as an adjunct to standard of care surgery vs. standard of care surgery alone for rotator cuff tear repair. The clinical trial will enroll 78 patients at ten clinical sites.
The ORTHO-R/PRP combination product has demonstrated quicker and better tissue repair than the standard of care surgery in a preclinical rotator cuff repair study.
Claude LeDuc, President and CEO, said, “Our ORTHO-R U.S. clinical trial will be one of the first FDA regulated Drug/Biologics combination product clinical trials in the orthobiologics field. We are making significant progress with pre-enrollment activities at each respective site. We are confident to start enrolling our first patients during the coming months.”
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