Evidence on the Safety and Efficacy of Ortho-R in a Large Animal Model

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Ortho Regenerative Technologies Inc. (“Ortho RTi” or the “Corporation”), an emerging Orthopaedic and Sports Medicine technology company, announced that a poster, entitled “Freeze-dried [Ortho-R] in Platelet-rich Plasma in Sheep Model of Rotator Cuff Repair,” was presented at the 39th SICOT Orthopaedic World Congress in Montreal, Canada.

The presentation given by Anik Chevrier Ph.D., a researcher from Montreal’s prestigious École Polytechnique, highlighted the results of a dose ranging study examining Ortho RTi’s Ortho-R technology in the biologic repair of rotator cuff injuries.  The study used histopathology, the microscopic examination of biological tissues in very fine detail, read by two blinded experts, as well as MRI imaging, to compare the results of Ortho-R versus standard of care in a non-clinical rotator cuff injury model in sheep.

Quoting directly from the poster, “[Ortho-R] modulated some rotator cuff healing processes in this large animal model, as revealed by a significant decrease in tendon gap and trends of improved structural appearance of the tendon and enthesis at 12 weeks post-operative.  The promising MRI and histological findings of [Ortho-R] treated ISP tendons would be expected to translate into superior mechanical performance, and this will be assessed in a future animal study.  Animals exhibited no visible signs of pain and experienced mostly mild transient lameness post-surgery which was similar for all treatment groups.  In addition, there was no treatment-specific effect on histopathology of internal organs, hematology parameters, serum chemistry parameters, urine chemistry parameters and synovial fluid cell differential, which suggests high safety.”

“We were excited to share this data at such a prestigious Orthopaedic meeting,” said Ortho RTi’s Chief Scientific Officer, Dr. Michael Buschmann.  “This study provides evidence on the safety and efficacy of Ortho-R in a large animal model that could potentially be translated to a clinical setting.  To that end, we are continuing to work diligently 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 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.

Source: https://www.nasdaq.com/press-release/evidence-on-the-safety-and-efficacy-of-orthor-in-a-large-animal-model-presented-at-2018-sicot-worl-20181010-01174

For Further Information

More on the orthopedic soft tissue repair market in the U.S. can be found in a series of reports published by iData Research entitled the U.S Market Report Suite for Orthopedic Soft Tissue Repair and Sports Medicine. The suite covers reports on the following markets: tendon reinforcement grafts, suture anchors, tenodesis screws, ACL/PCL replacement allografts, interference screws, intratunnel fixation devices, cortical fixation devices, cross-pins, washer and post, osteochondral allografts, meniscal allografts, autologous chondrocyte implantation, particulated juvenile allograft implant, microfracture adjunct, suture meniscal repair devices, implant meniscal repair devices, hybrid meniscal repair devices, hip radiofrequency probes, banana blades, hip access kits and disposable suture passers.

The iData report series on orthopedic soft tissue repair covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic soft tissue repair market data, register online or email us at [email protected] for a U.S Market Report Suite for Orthopedic Soft Tissue Repair and Sports Medicine brochure and synopsis.

iData ResearchEvidence on the Safety and Efficacy of Ortho-R in a Large Animal Model

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