Orthocell Ltd (ASX:OCC) has received positive results from its OrthoATI™ trial, establishing the efficacy of the treatment for rotator cuff tendon injuries.
There are currently no proven long-term non-surgical solutions to treat chronic shoulder tendon injuries, so OrthoATI™ targets an area of high unmet medical need.
The results from the randomised, multi-centre, controlled rotator cuff tendon clinical study show that OrthoATI™ is significantly more effective than existing treatments for the treatment of rotator cuff tendinopathy with intrasubstance tendon tear.
A staggering 95% of participants reported a return of function in the treated shoulder a year after receiving OrthoATI™ treatment, with an almost complete resolution of the pain by one-month post-treatment. This was sustained over the treatment period.
These patients had received an average of four failed conservative treatments, including physiotherapy and steroid injections, prior to the successful therapy.
Steroid treatment failure
“Patients exhibited a high degree of frustration with the reduced function in their shoulders and their ability to go about their daily lives," Orthocell managing director Paul Anderson said.
“There’s no genuine non-surgical solution for these difficult-to-treat tendon injuries and often surgery is not even recommended.”
Investors have responded positively, sending shares as much as 14.6% higher to A$0.59 while OCC's market cap is approximately A$109.71 million.
Participants who received a steroid injection had no meaningful improvement in function, and only a transient improvement in pain at the three-month mark, before returning to pre-treatment levels – 64% of these patients withdrew early from the study due to treatment failure.
Of these early withdrawals, 86% requested and received OrthoATI™ treatment, with overwhelmingly positive results.
Watch: Orthocell finds further success in clinical tendon study
“We are absolutely delighted with the study results for this challenging and debilitating condition which clearly demonstrates that OrthoATI™ is more effective than steroid injection for treatment of rotator cuff tendinopathy with intrasubstance tendon tear.," Anderson said.
"This is an important development milestone 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.”
US market beckons
OrthoATI™ is set to become the first FDA-approved injectable cell therapy in the orthopaedic space for the treatment of chronic tendon injuries – and Orthocell is poised to launch into the US marketplace to reach the large numbers of patients in that market who need this technology.
The lucrative US market is worth an estimated US$4-5 billion, with more than 480,000 rotator cuff patients per year who could benefit from the treatment.
Leading Australian orthopaedic surgeon and clinical trial lead, clinical professor Allan Wang of UWA, said: "The rotator cuff trial results are very encouraging. OrthoATI™ consistently improved pain and shoulder function in patients suffering chronic shoulder symptoms from rotator cuff tendinopathy and tear.
"Patients are pleased to have a non-surgical treatment option available, with reduced recovery times before returning to their work and recreational activity."
Athlete endorsement
Adding further credence to Orthocell's development of OrthoATI™, clinical trial patient Paul Speering said: “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.
"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.”