ORTHO REGENERATIVE TECHNOLOGIES ENTERS INTO A MATERIAL TRANSFER AGREEMENT WITH A GLOBAL STRATEGIC MEDICAL COMPANY FOR ITS ORTHO-R ROTATOR CUFF TEAR REPAIR PHASE I/II U.S. CLINICAL TRIAL

Rhea-AI Summary

Ortho Regenerative Technologies has secured a Material Transfer Agreement with a leading global medical company for its ORTHO-R rotator cuff tear repair clinical trial. This partnership will provide exclusive access to a proprietary PRP system, enhancing the uniformity of treatment across trial sites. The Phase I/II study aims to evaluate ORTHO-R's efficacy compared to standard care in 78 patients across 10 U.S. sites. Early results from preclinical studies indicate ORTHO-R could significantly improve tissue repair, positioning it as a pioneering product in the orthobiologics sector.

Positive

• Material Transfer Agreement with a leading global medical company to enhance clinical trial support.
• Potential for quicker and better tissue repair demonstrated in preclinical studies.
• The ORTHO-R trial will be among the first FDA regulated Drug/Biologics trials in orthobiologics.

Negative

• None.

MONTREAL, Feb. 7, 2022 /PRNewswire/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTC: ORTIF) ("Ortho" or the "Company"), a clinical-stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced it has entered into a Material Transfer Agreement ("MTA") with an undisclosed, industry-leading, global strategic medical company (the "Strategic Company") for the exclusive use of their proprietary platelet-rich plasma ("PRP") system in Ortho's upcoming ORTHO-R rotator cuff tear ("RCT") repair, phase I/II U.S. clinical trial. The Strategic Company will provide the PRP system disposable kits for all enrolled patients in the study as well as technical and training support. Ortho, has in return, provided the Strategic Company with a right of "first offer" to distribute ORTHO-R in combination with their proprietary PRP System.

"We are thrilled to have the contribution of an industry-leading player to support our ORTHO-R U.S. clinical trial. Using their state-of-the-art platelet concentration systems at all clinical trial sites will create uniformity throughout all study sites and will help maximize our chances of success with our trial", said, Claude LeDuc, President and CEO of Ortho. "Our ORTHO-R U.S. clinical trial will be one of the first FDA regulated Drug/Biologics combination product clinical trial 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.

During the PRP coagulation and degranulation processes, multiple expressed cytokines such as growth factors contribute to new tissue repair. With its unique mucoadhesive and stabilizing features, resulting in increasing the biologic activity of PRP, the ORTHO-R / PRP combination product has shown quicker and better tissue repair than the standard of care surgery in a GLP preclinical RCT repair study.

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.

About Ortho Regenerative Technologies Inc.

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.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

View original content to download multimedia:https://www.prnewswire.com/news-releases/ortho-regenerative-technologies-enters-into-a-material-transfer-agreement-with-a-global-strategic-medical-company-for-its-ortho-r-rotator-cuff-tear-repair-phase-iii-us-clinical-trial-301476245.html

SOURCE Ortho Regenerative Technologies Inc.

FAQ

What is the ORTHO-R rotator cuff repair clinical trial about?

The ORTHO-R trial evaluates the efficacy and safety of ORTHO-R as an adjunct to standard surgical repair for rotator cuff tears.

How many patients will be enrolled in the ORTHO-R clinical trial?

A total of 78 patients will be enrolled across ten clinical sites in the U.S.

What is the significance of the Material Transfer Agreement?

The agreement ensures access to a proprietary PRP system, enhancing the uniformity and quality of treatment in the trial.

When is the ORTHO-R clinical trial expected to start enrolling patients?

Patient enrollment is expected to begin in the coming months.

What are the expected outcomes of the ORTHO-R clinical trial?

The trial aims to demonstrate improved tissue repair compared to standard surgical methods.