Orthocell Ltd (ASX:OCC), a regenerative medicine company, welcomes results from a 'crossover' trial for the OrthoATI™ rotator cuff treatment that underscores the high success rate and long efficacy period of the treatment in comparison with corticosteroid treatments.
Rotator cuff injuries are painful and debilitating, having little to no effective treatments bar surgery and treatment generally consisting of rest, ice and physical therapy.
Corticosteroid treatments are one of the few pain relief options available but don’t address the underlying pathology of tendon degeneration
In Orthocell’s randomised, multicentre, controlled rotator cuff tendon clinical study, patients who were randomised to receive a corticosteroid injection had the option to 'crossover' to the OrthoATI™ treatment if there was a lack of response in the corticosteroid arm of the study.
Read: Orthocell releases clinical data confirming OrthoATI™ efficacy in treating chronic shoulder tendon injuries, shares up
Some 82% of participants in the corticosteroid arm chose to cross over to OrthoATI™ and experienced almost complete resolution of pain six months post-treatment, which was sustained at 12 months, according to the company’s results.
Important validation for OrthoATI™
“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," Orthocell managing director Paul Anderson said.
“This is an important validation for OrthoATI™ and the company.
“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.”
All crossover patients post-treatment reported shoulder function ‘consistent with a successful outcome at 12 months’, having received an average of five failed conservative treatments including physiotherapy and at least two steroid injections.
No participants in the crossover required additional treatment for their shoulder injury – either injections or surgery – in the 12-month follow-up period.
These results mirrored those of the original OrthoATI™ treatment group, which showed ‘clinically and statistically significant improvements in shoulder pain and function’.
"Life-changing for me"
Anecdotal accounts from trial patients appear to strongly support the company’s data.
“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,” said Paul Speering, a patient in the clinical trial.
“I was so fortunate to be involved in this study, and I wish that more people would be able to take advantage of the treatment. It truly has been life-changing for me.”
Investors have also welcomed the news, sending shares higher by 4.94% to A$0.425 within the first half hour of trading.