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Ortho RTi Signs Agreement with a Leading CMO for the Manufacture of cGMP Finished Dosage Form Ortho-R in Preparation for Planned First-in-Human Study
KIRKLAND, Quebec, Sept. 06, 2018 (GLOBE NEWSWIRE) -- Ortho Regenerative Technologies Inc. (CSE: ORTH) (“Ortho RTi” or the “Corporation”), an emerging Orthopaedic and Sports Medicine Technology company, today announced that it has entered into an agreement with a leading Contract Manufacturing Organization (“CMO”) operating within the global biopharmaceutical industry to commence work on providing the Corporation with current good manufacturing practice (“cGMP”) finished dosage form quantities of Ortho-R for currently planned clinical trials and strategic partnering initiatives.
“The initiation of this technology transfer from École Polytechnique to a well-regarded, cGMP-compliant manufacturing site marks an important step forward toward achieving our goal of taking this potentially game-changing technology into the clinic,” commented Ortho RTi’s Executive Chairman and CEO, Dr. Brent Norton. “Importantly, this will allow us to bypass the development risks associated with going into first-in-human studies by having scalable, cGMP materials. Also, as we move towards approvals by the U.S. Food and Drug Administration for our indications for use, and continue pursuing joint development initiatives with interested industry players, it should help give potential strategic partners confidence that they can rely on high quality, commercial production of Ortho-R.”
About Ortho Regenerative Technologies Inc.
Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic tissue repair devices to dramatically improve the success rate of sports medicine surgeries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to ligaments, tendons and cartilage. The polymer can be directly placed 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. Visit us on the internet at www.orthorti.com.
This news release may contain certain forward-looking statements regarding the Corporation’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 Corporation 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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