FDA Pre-submission filed, new patent issued, GMP production and Strategic relationships all progressing
KIRKLAND, QC, Dec. 12, 2018 /CNW/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) ("Ortho RTi" or the "Corporation"), an emerging Orthopaedic and Sports Medicine technology company, announced that its recently completed study has been chosen by a peer reviewed panel as worthy of a podium presentation at the 2019 ICORS (International Combined meeting of Orthopaedic Research Societies) congress in June. ICORS attracts Orthopaedic surgeons, sports medicine specialists, physicians and research scientists from around the globe and is focused on how new discoveries translate into improved clinical care. The podium presentation will feature the study titled "Freeze-dried chitosan solubilized in platelet-rich plasma in a sheep model of rotator cuff repair".
"Our scientific evidence continues to excel and gather the attention of world experts. This will be our 16th peer-reviewed abstract, poster, manuscript and now podium presentation in the last two years. Further, this is another key publication resulting from work with experts at New York City's renowned Hospital for Special Surgery," said Ortho RTi's Chief Scientific Officer, Dr. Michael Buschmann.
Over the last weeks our business and exposure has continued to progress significantly.
- Last Friday we submitted our formal Pre-Submission package to the FDA seeking guidance after our recent data showed statistically significant results in as little as 3 months. The package included data from all of our studies and highlighted that Ortho-R has shown structural improvements at 6 months and as a second clinical benefit has showed improved speed of healing as evidenced by our 3-month data.
- Over the same time period our Intellectual Property assets continued to grow with progress on multiple patent files as well as another European patent issuing in Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland & Liechtenstein, and the United Kingdom.
- As part of the evolving scientific validation of our technology, a recent manuscript was selected for publication in an upcoming issue of the Journal of Biomaterials which is expected to be published in the first months of 2019.
- Finally, our technology transfer to production and scale-up has progressed through a critical milestone with our first finished product lots in the process of being completed.
"The combination of these initiatives have also allowed us to make strong progress with strategic partners and our goals of assessing and co-developing our product for other potential clinical uses" said Dr. Brent Norton, CEO of the company."
About the ICORS
The International Combined Orthopaedic Research Societies (ICORS) serves as an alliance of societies to promote basic, translational, and clinical musculoskeletal research worldwide. The Combined Meeting was launched in 1992 by founding member societies; Orthopaedic Research Society, Canadian Orthopaedic Research Society, European Orthopaedic Research Society, and the Japanese Orthopaedic Association. The meeting has convened every three years since 1992 and rotated to the different country organizations. For 2019 the ICORS annual meeting is being held in Montreal, Quebec, in conjunction with the Canadian Orthopaedic Research Society and the Canadian Orthopaedic Association annual meetings.
About Rotator Cuff Injury
The rotator cuff is the name given to the collection of four tendons that stabilize the shoulder joint. The tendons around the joint can suffer tears as a result of injury to the tendon or as a result of degeneration over time. Repetitive overhead activity is often associated with cuff tears. Symptoms include a dull, aching pain, and patients often suffer secondary symptoms including lack of sleep and weakness in the arms resulting from a lack of exercise. If conservative therapy is not successful, surgery will often be performed. The principal aim of surgical intervention is to reattach the torn tendon to the bone. The standard of care involves the use of suture anchors placed into the bone and the tendon then being held in place with sutures.
About Ortho Regenerative Technologies Inc.
Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic soft tissue repair technologies 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. Further information about Ortho RTi is available on the Company's website at www.orthorti.com and on SEDAR at www.sedar.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.
SOURCE Ortho Regenerative Technologies Inc.
For further information: Brent Norton, Chief Executive Officer, 514.782.0951, [email protected]