Orthocell Limited announced positive results from the crossover patient extension arm of its randomised, multicentre, controlled rotator cuff tendon clinical study. This additional data supports the original randomised controlled RC Study results, which demonstrated that OrthoATITM is a safe and effective treatment for patients suffering from rotator cuff tendinopathy with intrasubstance tendon tear compared directly to the standard of care. Rotator cuff tears lead to considerable pain and disability, and conservative treatment options, do not address the chronic underlying pathology of tendon degeneration.

OrthoATITM represents a potential breakthrough treatment option to resolve pain and return functional mobility for this debilitating condition. Watch video here. To be eligible for the RC Study, participants had to have suffered from pain and loss of shoulder function for at least 6 months and had received an average of 4 failed treatments prior to enrolment.

Following treatment, assessment of pain and shoulder function showed that the OrthoATITM group had significantly better results compared to the steroid group at all post-treatment time points. Participants in the observational extension study had received at least two corticosteroid injections and had an average symptom duration of 33.1 months, indicating a chronic condition that was unlikely to resolve itself without further treatment. Nine of eleven (82%) participants who received corticosteroid treatment in the RC trial requested subsequent crossover treatment with OrthoATITM due to lack of improvement in their shoulder pain and/or function; On average, participants in the crossover group experienced almost complete resolution of painby month 6 following treatment with OrthoATITM; The crossover group also experienced clinically important improvements in shoulder function at 6 months following OrthoATITM treatment; Results in the crossover group mirror those seen in the OrthoATITM group in the original RC trial; No participants in the crossover group required additional treatment for their shoulder injury within the 12 month follow-up period; and No safety concerns for OrthoATITM were identified.

Initial market sizing undertaken by Orthocell suggests that Ortho-ATITM could be applicable to >480,000 rotator cuff patients per year in the US alone, which equates to a market opportunity of approximately US$4-5 billion 1. Ongoing work by Orthocell aims to also assess the savings to the health system that may be delivered by OrthoATITM when accounting for more effective pain relief and return of function, return to work and avoidance of surgical costs. Ortho-ATITM can be used in both pre-surgical and post-surgical applications, not only in treating rotator cuff injuries, but many other tendon injuries and is at the forefront of a significant and increasing market opportunity. The Orthocell team was responsible for the initial development of a similar cell therapy product for the regeneration of cartilage which is now being commercialised by US company Vericel, which currently generates more than $120 million in sales and is only used to treat one target joint in the body.

Vericel currently has a market capitalisation of approximately $1.2 billion. Orthocell is in a strong position to advance its US commercialisation strategy to deliver the first injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries. 2 The results of this study demonstrate that OrthoATITM is more effective than steroid injections for treatment of rotator cuff tendinopathy with intrasubstance tendon tear.

The Company continues to progress its US plans with the evaluation of technology transfer options, FDA engagement and commercial preparation activities to prepare OrthoATITM for a randomised controlled study under FDA supervision. The observational extension study has been led by Clinical Professor Allan Wang. Dr Jeff Hughes was an investigator in the full RC study.

The RC Study was a randomised, multicenter, open-label study designed to assess OrthoATITM, in comparison to steroids as an emerging treatment for patients with rotator cuff tendinopathy with intrasubstance tendon tear. A total of 30 participants verified by MRI with symptom duration >6 months, and who had previously received physiotherapy AND one or more corticosteroid injections were treated. Participants were randomised to receive an ultrasound guided injection of tendon derived cells that had been cultured from a sample drawn from each patient or an ultrasound guided injection into the subacromial space of Celestone Chronodose.