Sportspersons and athletes can look forward to bidding adieu to steroids when it comes to the treatment of rotator cuff tendonitis, i.e. swelling of the shoulder muscles, as regenerative medicine company Orthocell (ASX: OCC) has a better solution: cell therapy. The Company conducted clinical trials for its patented injectable cell therapy solution, OrthoATI, and announced positive results from the crossover patient study.
Orthocell conducted a randomised, multicentre, controlled rotator cuff tendon clinical study (‘RC Study’), which demonstrated that OrthoATI™ is a safe and effective treatment for patients suffering from rotator cuff tendinopathy. What’s more? Turns out, OrthoATI was more effective than the typical treatment for this syndrome, steroid corticosteroid injection.
In fact, 82% of participants who received corticosteroid treatment in the RC trial requested subsequent crossover treatment with OrthoATI citing lack of improvement in their shoulder pain. On average, participants in the crossover group experienced almost complete resolution of pain in six months, and no safety concerns for OrthoATI were identified. One of the patients from the clinical trial, Paul Speering, detailed, “The steroid treatment didn’t work and since the OrthoATI™ treatment, as a drug free and fully drug tested athlete, I have become both a Masters National Powerlifting Champion and the Oceanias Masters Powerlifting Champion, and hold all four State Records in my age and weight category. It truly has been life changing for me.”
This successful trial could mean big things for OrthoATI, even positioning it favourably to become the first FDA-approved injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries.
Orthocell Managing Director, Paul Anderson, shared, “We are delighted with the crossover patient study results clearly demonstrating that OrthoATI™ is more effective than steroid injection for treatment of rotator cuff tendinopathy with intrasubstance tendon tear. This is an important validation for OrthoATI™ and the Company.”
He added, “We are now in a very strong position to progress our US commercialisation strategy to deliver the first injectable cell therapy in orthopaedics that truly addresses the cause of degeneration and returns patients to full use of their chronically damaged tendons.”
To be eligible for the study, participants had to have suffered from pain and loss of shoulder function for at least six months and received an average of four failed treatments (including physiotherapy, corticosteroid or Platelet Rich Plasma or ‘PRP’ injections), before enrolment. Participants in the observational extension study had received at least two corticosteroid injections and had an average symptom duration of 33.1 months, indicating a chronic condition that was unlikely to resolve itself without further treatment.
Australian orthopaedic surgeon and clinical trial lead, clinical professor Allan Wang of University of Western Australia, noted, “In the year after their OrthoATI™ treatment, none of the patients required additional medical treatment for their shoulder injury and their symptoms were largely resolved, similar to the patients who received OrthoATI™ in the original trial. These positive outcomes are encouraging and support the results from the original trial.”
Currently, OrthoATI is only available in Australia, New Zealand, and Hong Kong, via the Special Access Scheme, available to patients who fail the conservative treatment options, like steroids and exercise. The Company’s goal is to become FDA-approved and take OrthoATI to the USA. As per its research, OrthoATI could help up to 500,000 rotator cuff patients annually in the US alone. This is a market opportunity worth US$4 to 5 billion. Orthocell feels that its cell therapy could also benefit healthcare institutions by helping them cut costs, by avoiding most surgical costs and even becoming applicable to issues beyond rotator cuff tendonitis.
Alinda is a Business Reporter for The Sentiment
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