Orthocell (ASX:OCC) has announced the final results from its clinical study comparing OrthoATI to surgery to treat severe, chronic, treatment-resistant lateral epicondylitis.
OrthoATI is an autologous cell therapy comprising tendon-derived cells for the repair and relief of chronic tendon injuries.
The company said the data confirmed that the study met its primary endpoint, demonstrating that OrthoATI is as effective as surgery in treating lateral epicondylitis.
Lateral epicondylitis, also known as 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 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. However, approximately 10 per cent of 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. Surgery is invasive, costly, and not consistently successful. It also requires strict rehabilitation protocols.
Orthocell said OrthoATI represents a potential breakthrough nonsurgical treatment option to resolve pain and return functional mobility for this debilitating condition.
The study was led by Clinical Professor Eugene Ek (Monash University), Dr Jason Harvey, Clinical Professor Allan Wang (University of Western Australia), and Professor Ming Hao Zheng (University of Western Australia and co-founder of Orthocell).
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. 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."
