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Contracting procedures completed for 6 of the 10 clinical trial sites
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5 sites fully activated, with ongoing patients' screening and recruitment
MONTREAL, June 13, 2022 /CNW/ - 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:
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Rothman Institute, PA,
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OrthoIndy Research Foundation, IN
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University Orthopedics, PA
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Tucson Orthopedics, AZ
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Holy Cross Orthopedic Institute, FL
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OrthoVirginia Institute, VA, (site activation imminent)
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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.