Managing director Paul Anderson said: “We are delighted to complete the patient recruitment phase of this highly focused randomised controlled trial (RCT), designed to assess the effectiveness of Autologous Tenocyte Injection (Ortho-ATI®) as a treatment to a difficult clinical problem with limited alternatives.”
Large market opportunity
Ortho-ATI is a novel cell therapy developed to treat chronic tendon injuries and is at the forefront of a large and increasing market opportunity, estimated to be worth >US$7.7 billion and growing.
In studies conducted by Orthocell to date, Ortho-ATI has been shown to be a cost-effective long-term, nonsurgical solution for difficult to treat tendons including the rotator cuff, elbow, gluteal, patellar and achilles.
Rotator cuff tendinopathy and tear (which manifests as severe shoulder pain) is a common and often difficult injury to treat and affects more than 50% of adults over 50 years of age.
The trial is led by Clinical Professor Allan Wang (former President of the Australian Elbow and Shoulder Society), Dr Jeff Hughes (current President of the Australian Elbow and Shoulder Society), Dr Jane Fitzpatrick, and Professor Ming Hao Zheng at the University of Western Australia (UWA).
To ensure effectiveness, patients were excluded from enrolling in the trial if they presented with any of the 16 exclusion criteria, including previous treatment injections in the prior three months; previous shoulder surgery or significant pathology of affected shoulder (eg inflammatory joint disease); or bilateral shoulder pathology.
Whilst the very detailed exclusion criteria caused delays to the anticipated recruitment timeframes, it is consistent with best practice and is not reflective of the significant patient population that is normally suitable for treatment with OrthoATI.