Ortho Regenerative Technologies Inc (CSE:ORTH) is developing novel tissue repair therapies with the goal of dramatically increasing the success rates of surgeries for soft tissue injuries such as rotator cuff and meniscus tears.
Through its proprietary drug/biologic platelet-rich plasma (PRP) combination technology platform, the Montreal-based company is developing formulations for the regeneration of new tissue in various musculoskeletal conditions.
Soft tissue tears are common conditions among people over the age of 45 and athletes, and unfortunately, the surgical repair of these injuries has had a relatively high failure rate.
Tears to the rotator cuff, the four tendons that stabilize the shoulder joint, result in more than 600,000 surgeries in the United States every year, of which about 50% result in a re-tear or non-healing.
Injuries to the meniscus, the cartilage that acts as a shock absorber between the shinbone and thighbone, are also common, resulting in 1.1 million surgeries per year with a failure rate ranging between 20% and 40%.
The relatively high failure rate of these surgeries presents an enormous opportunity given the cost and inconvenience of readmission, revision surgery, and physical therapy for both patients and healthcare providers.
“There’s a deep need in the marketplace to help improve the outcome of these surgical treatments,” Ortho Regenerative CEO Philippe Deschamps told Proactive.
“Regenerative medicine is the next frontier as we try to find ways to regenerate tissue rather than just treating symptoms.”
Ortho Regenerative acquired its technology platform from the Montreal Polytechnique lab, meaning the company owns the intellectual property outright.
The company maintains a close relationship with the university, which allows it to remain on the cutting edge of scientific research in the regenerative medicine market.
As part of its crackdown on businesses promoting unapproved and unproven regenerative medicines, from May 31, 2021, the US Food and Drug Administration introduced new requirements for regenerative medicines which require developers of these products to obtain a Biologics License.
“The Polytechnique had already started the preclinical work consistent with the Biologics License process and we were able to complete that work — now we are in the regulatory lead because we started way before everyone else,” Deschamps said.
An ‘elegantly simple’ approach
One thing that soft tissue, ligaments, and tendons have in common is that they are not well-vascularized, meaning they do not have a lot of blood flowing through them. When they are surgically repaired with sutures, what mostly forms are scar tissues.
According to Deschamps, the idea behind the drug/biologic PRP platform is to essentially mix a part of the patient’s blood called PRP — obtained by spinning the blood in a centrifuge — combine it with a sticky biopolymer and then apply it to the surgically repaired soft tissue following the surgical repair.
The blood stays resident on that surgical repair for four to six weeks so it has time to deliver the PRP repair mechanism, Deschamps explained. Without the sticky biopolymer, PRP dissipates within 24 hours, meaning it cannot bring its restorative power as effectively to the surgical repair.
Deschamps said Ortho Regenerative’s approach to improving the success rate of these injury repairs goes back to what happens when the body heals itself after a simple cut: first, it bleeds, then a scab forms and under the scab, blood goes to work to repair what has been damaged.
“What we saw in the preclinical data is that the tissue, rather than being mostly scar tissue, is about 80% of what looks like native tissue,” Deschamps said.
The product is designed to fit seamlessly into current surgical techniques, requiring no specialized equipment and adding only a maximum of five to 10 additional minutes to surgical time.
Compared to other potential soft tissue repair solutions being developed, Ortho Regenerative’s platform is considerably simpler and thus, likely less costly than other regenerative therapies. Deschamps said the company hopes that its treatment will help patients with soft tissue injuries recover more robustly and quickly, allowing them to get back to their normal routines in a much shorter time.
“Of all the regenerative treatments being developed, our platform is probably the simplest and easiest to produce from a manufacturing standpoint because we’re using a patient’s own blood that just needs to be spun down in a centrifuge where the PRP portion of the blood can be easily identified and then mixed with the drug/biologic and delivered by the surgeon through the start-of-care procedure.”
“This is elegantly simple.”
Research pipeline
In December 2021, Ortho Regenerative was granted FDA Investigational New Drug clearance to initiate its Phase 1/2 rotator cuff tear repair clinical trial.
The trial will involve 78 patients across 10 sites. Six of the identified sites are fully contracted and four have begun recruiting patients, with all contracts and site initiations expected to be completed in July or August.
Ortho Regenerative is first targeting the rotator cuff, to be followed by the meniscus and tendinopathy, referring to any tendon condition that causes pain and swelling such as tennis elbow, golfer’s elbow, and Achilles heel injuries.
Upon the completion of its Phase 1/2 research, which Ortho Regenerative anticipates to be by the end of 2023, Deschamps said the company expects to make a decision about finding a development partner for its next steps.
He said it is unlikely that Ortho Regenerative would take its research to Phase 3. “Once we clear this important Phase 1/2, we will either bring on a development partner or sell the organization to the highest bidder,” he added.
“We certainly hope and believe based on potential positive results, we will be able to generate interest,” Deschamps concluded.
Contact Emily at emily.jarvie@proactiveinvestors.com
Follow her on Twitter @emilyjjarvie