The RC study was designed to assess the effectiveness of Ortho-ATI, compared to corticosteroids, as a non-surgical treatment to a difficult clinical problem with limited treatment options.
Final data collection and validation is progressing and Orthocell expects that results will be available in the fourth quarter of 2021.
The Ortho-ATI shoulder tendon study is the first high-quality randomised controlled study completed for this type of treatment and the company believes it is well-positioned to become the first FDA approved injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries.
“Important development milestone”
Orthocell managing director Paul Anderson said: “We are delighted to have completed the 12-month follow-up of the last patient treated in this highly focused, randomised controlled study.
“This is an important development milestone for Ortho-ATI and the company, representing the first randomised controlled trial for a tendon cell therapy to be completed for this indication globally.”
Shortcoming in current options
According to the company, shoulder pain is the third most common reason to visit a general practice for a chronic musculoskeletal condition and the most common cause is rotator cuff tendinopathy and tear.
Rotator cuff tears lead to considerable pain and disability, reducing the quality of life and absenteeism from work, and are a major burden on healthcare resources.
Currently, there are no proven long-term non-surgical solutions to repair chronic shoulder tendon injuries.
Opportunities for Ortho-ATI
Orthocell believes that if Ortho-ATI shoulder tendon study meets its objectives, it will be the first high-quality randomised controlled trial successfully completed for this indication.
This will also place Orthocell in a strong position to progress its US commercialisation strategy to deliver the first injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries.
The initial market sizing undertaken by the company suggests that Ortho-ATI could be applicable to around 470,000 rotator cuff patients per year in the US alone, which equates to a market opportunity of approximately US$2.8 billion.
Ortho-ATI can be used in both pre-surgical and post-surgical applications and is at the forefront of a large and increasing market opportunity.
The company is on track to complete data analysis for the RC study with data expected to be available in the December quarter of 2021.
Orthocell is working on the regulatory strategy to gain approval from the FDA and is also designing the study to facilitate the first global approval of a cell therapy for tendon injuries.