Positive Histopathology Data from Pilot Study Adds to Growing Body of Evidence Supporting the Utility of Ortho-R in Rotator Cuff Repair

Wednesday, June 13, 2018 General News
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KIRKLAND, QC, June 13, 2018 /CNW/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) ("Ortho RTi

" or the "Corporation") an emerging Orthopaedic and Sports Medicine Technology company, today announced positive outcomes data from a study examining its Ortho-R technology in the biologic repair of rotator cuff injuries.

Conducted

by researchers from Montreal's prestigious E?cole Polytechnique, the dose ranging study used histopathology, the microscopic examination of biological tissues in very fine detail, read by two blinded experts, to compare the results of Ortho-R versus standard of care in a non-clinical rotator cuff injury model in sheep.  

In this study, treatment with Ortho-R was shown to improve healing versus standard of care, with the highest Ortho-R dose having the greatest effect. Treatment with Ortho-R showed improvements in the structural organization of the tendon and the structural appearance of the tendon insertion site. In addition, Clinical signs and histopathology showed no treatment-specific adverse effects, suggesting high safety of Ortho-R.

"The improved histological appearance and the previously observed reduced tendon gap size by MRI at the repair site are expected to translate into superior biomechanical performance", said Ortho RTi's Chief Scientific Officer, Dr. Michael Buschmann. "Further, the principal findings of three independent parameters showing improvement - tendon organization, structure of the insertion site and tendon gap - are very strong indicators of a beneficial effect of treatment by Ortho-R compared to the standard of care."

Detailed results from the study will be submitted to a future medical conference and for publication.

"Histopathology is considered the 'gold standard' in this type of analysis, as the structure of a tissue reveals its function," said Ortho RTi's Executive Chairman and CEO, Dr. Brent Norton. "With more than 500,000 rotator cuff surgeries being performed in the United States each year, our goal is to take this potentially game-changing technology into the clinic as soon as possible. To that end, we are continuing to work towards the submission of an Investigational New Drug Application to the U.S. Food and Drug Administration."

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, including weight lifting is often associated with cuff tears. Symptoms include a dull, aching pain, and patients often suffer secondary symptoms including a lack of sleep and weakness in the arms resulting from a lack of exercise. If conservative therapy (for example, painkillers and physical rehabilitation) 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 being then 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 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.

Forward-Looking Statements

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.



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