Final clinical study results have demonstrated Orthocell Ltd (ASX:OCC, OTC:ORHHF)’s tendon cell therapy, OrthoATI™, to be as effective as surgery for the treatment of severe, chronic, treatment-resistant lateral epicondylitis, or tennis elbow.
The data confirmed that the lateral epicondylitis study (LE study) met its primary endpoint, demonstrating that OrthoATI™ is as effective as surgery in the treatment of lateral epicondylitis, but is minimally invasive and cost-effective.
Investors have responded positively, sending shares 10% higher in early ASX trading to A$0.46 and they are up considerably from $0.325 at the market close on October 25.
A minimally invasive solution to chronic pain
Tennis elbow results in considerable pain and disability and affects millions of people every year.
Conservative treatment options, such as rest, nonsteroidal anti-inflammatory drugs (NSAIDs) or physiotherapy are usually effective and the symptoms resolve within six months. If symptoms persist, patients may be offered steroid injections to manage the pain and inflammation.
Yet around one in 10 patients fail to respond to conservative treatment and steroid injections. For patients with severe, chronic lateral epicondylitis that fails to respond to conservative treatment, recovery without further intervention is unlikely and the only option remaining is surgery.
Yet surgery is invasive, costly, not always successful and requires strict rehabilitation protocols.
As supported by the recent clinical study, OrthoATI™ represents a potential breakthrough nonsurgical treatment option to resolve pain and return functional mobility for this debilitating condition.
Orthocell managing director Paul Anderson said: “These significant clinical results display once again the continued success of the Orthocell team, its scientific capabilities and its potential to provide global therapeutic products.”
Potential breakthrough nonsurgical treatment
The study participants suffered from pain and loss of elbow function for over six months and had previously received and failed conservative therapy including injectables (corticosteroid/PRP), prior to enrolment in the study.
Following treatment, assessment of pain and function showed that OrthoATI™ was as effective as surgery in treating the symptoms of severe, chronic lateral epicondylitis.
Importantly, treatment with OrthoATI™ resulted in reduction of pain and improvement in function sooner than treatment with surgery. Participants in the OrthoATI™ group were also able to return to work on average one month sooner than patients treated using surgery.
The LE Study was a statistically powered, randomised, multicenter, open-label, non-inferiority study designed to compare OrthoATI™ to the 'gold standard' of surgery for patients with severe, chronic, treatment-resistant lateral epicondylitis.
Lead study investigator and clinical professor Eugene Ek will present the study results at the 83rd Australian Orthopaedic Association Annual Scientific Meeting.
Orthocell chief scientific officer Professor Minghao Zheng said: “Returning patients to pain-free function sooner than surgical repair for severe lateral epicondylitis, is a further validation and significant milestone for the commercial development of OrthoATI™.
“We are absolutely delighted with the study results and the potential to deliver the first injectable cell therapy in orthopaedics, that truly addresses the cause of injury and returns patients to full use of their chronically damaged tendons without the need for surgery.”
Corporate advisor sought
Based on the successful study outcomes, Orthocell will look to appoint a US-based corporate adviser to assist the company in securing a strategic partner to progress OrthoATI™.
“Our decision to appoint a US-based corporate adviser will enhance progress of the tendon cell therapy and allow us to continue our focus on FDA approval for our leading nerve repair product, Remplir™,” said Anderson.
Significant market opportunity
Orthocell says that initial market sizing suggests that OrthoATI™ could be applicable to more than 350,000 tennis elbow patients per year in the US alone, which equates to a multi-billion market opportunity.
Ongoing work by the company is aiming to assess the savings to the health system that may be delivered by OrthoATI™ when accounting for more effective pain relief and return of function, return to work and avoiding surgical costs.