ORTHO REGENERATIVE TECHNOLOGIES ANNOUNCES ENROLLMENT OF FIRST PATIENT IN ITS U.S. PHASE I/II ROTATOR CUFF TEAR REPAIR CLINICAL TRIAL
Ortho Regenerative Technologies has announced the successful completion of the first patient surgery in its U.S. Phase I/II rotator cuff tear repair clinical trial, marking a significant milestone for the company. With eight clinical centers now fully initiated, patient enrollment is progressing, and additional surgeries are scheduled. The trial aims to evaluate the safety and efficacy of ORTHO-R as an adjunct to standard care surgery, enrolling a total of 78 patients across ten U.S. sites. The Phase I safety portion is expected to conclude by September, pending enrollment confirmation.
- Successful completion of the first patient surgery in U.S. Phase I/II clinical trial.
- Eight clinical centers initiated and actively recruiting patients.
- Additional surgeries already scheduled.
- None.
- First patient surgery completed; additional surgeries already scheduled
- 8 clinical centres now fully initiated and recruiting / screening for patients
MONTREAL, July 27, 2022 /PRNewswire/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTCQB: ORTIF) ("Ortho" or the "Company"), a clinical-stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced the initiation of patients' enrollment following completion of the first patient surgery in its U.S. Phase I/II rotator cuff tear repair clinical trial.
The first patient surgery was successfully completed at the Tucson Orthopaedic Institute in Tucson, Arizona.
"The enrollment of our first patient in the U.S. Phase I/II rotator cuff tear repair clinical trial is our most significant clinical milestone to date. With 8 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", said, Philippe Deschamps, CEO.
The ORTHO-R Phase I/II clinical study is a prospective, randomized, controlled, and blinded clinical trial, to evaluate the safety and efficacy of 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 a total of 78 patients at ten clinical sites throughout the U.S.
Ortho 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. Our proprietary RESTORE technology platform is a proprietary muco-adhesive Chitosan-based biopolymer matrix, specifically designed to deliver biologics such as Platelet-Rich Plasma (PRP) or Bone Marrow Aspirate Concentrate (BMAC), to augment and guide the regeneration of new tissue in various musculoskeletal conditions. ORTHO-R, our lead Chitosan-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. Other formulations are being developed for cartilage repair, bone void filling and osteoarthritis treatment. The proprietary Chitosan-PRP combination ORTHO-R implant can be directly applied into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. Considering the significant potential of our technology platform, Ortho continues to assess new therapeutic target uses outside of the soft tissue repair field. Further information about Ortho is available on the Company's website at www.orthorti.com and on SEDAR at www.sedar.com. Also follow us on LinkedIn and Twitter.
Forward-Looking Statements
This news release may contain certain forward-looking statements regarding the Company's expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.
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SOURCE Ortho Regenerative Technologies Inc.
FAQ
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