ORTHO REGENERATIVE TECHNOLOGIES INITIATES PATIENTS RECRUITMENT FOR ITS U.S. PHASE I/II ROTATOR CUFF TEAR REPAIR CLINICAL TRIAL
Ortho Regenerative Technologies Inc. (CSE: ORTH, OTCQB: ORTIF) announced progress in its U.S. Phase I/II clinical trial for rotator cuff tear repair. As of June 13, 2022, contracting procedures are completed for six of ten clinical trial sites, with five sites fully activated and actively screening patients. The company aims to report on key milestones, including patient recruitment and safety outcomes. CEO Philippe Deschamps expressed confidence in the trial's progress, emphasizing the sites' qualifications and patient volume.
- Completion of contracting procedures for 6 out of 10 clinical trial sites.
- 5 clinical sites fully activated, actively recruiting patients.
- Emphasis on high-quality clinical trial sites with experienced investigators.
- Budget negotiations incomplete for one clinical site.
- Activation of remaining sites may lead to delays in patient recruitment.
- Contracting procedures completed for 6 of the 10 clinical trial sites
- 5 sites fully activated, with ongoing patients' screening and recruitment
MONTREAL, June 13, 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, is pleased to report on the progress of its U.S. Phase I/II rotator cuff tear repair clinical trial.
The following clinical sites are currently recruiting and screening patients for randomization in the Phase I/II study:
- Rothman Institute, PA,
- OrthoIndy Research Foundation, IN
- University Orthopedics, PA
- Tucson Orthopedics, AZ
- Holy Cross Orthopedic Institute, FL
- OrthoVirginia Institute, VA, (site activation imminent)
- Remaining four sites to be activated over the coming months.
"I am pleased with the recent progress in accelerating our U.S. Phase I/II clinical trial related activities", said company CEO, Philippe Deschamps. "The budget negotiations have been completed for all centers but one, the majority of clinical trial agreements have been executed with site initiation visits either completed or soon to be completed. We are also very pleased with our choice of clinical trial sites. They were specifically chosen for the volume of patients they treat, the outstanding qualifications of their clinical investigators and their reputation for research excellence. We look forward to start reporting soon on patient enrolment status", continued Deschamps.
The Company intends to report regularly on key clinical milestones going forward, such as first patient recruitment, the end of the Phase 1 safety portion of the program after 5 patients treated, and general patient recruitment status at the end of each quarter.
The Company also continues to look at additional potential applications to be derived for its proprietary Drug/Biologic PRP combination product to maximize value creation for all its shareholders.
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.
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.
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SOURCE Ortho Regenerative Technologies Inc.
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