Orthocell Ltd (ASX:OCC) is a step closer to market with its Autologous Tenocyte Injection (Ortho-ATI) shoulder tendon study.
The therapy is on track to become the first FDA-approved injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries.
The regenerative medicine company today announced that the rotator cuff tendon study database has been locked, which indicates the data has been verified by clinical investigators and submitted for analysis.
“This is an important development milestone for the company,” Orthocell managing director Paul Anderson said. “I am delighted to have reached this pivotal stage of the study.”
This is the first randomised cellular therapy study to examine non-surgical solutions to this condition anywhere in the world.
No existing solutions
There are no existing long-term non-surgical solutions to repair chronic shoulder tendon injuries.
Conservative treatment options include rest, physical therapy, anti-inflammatory drugs (NSAIDs) and injectable corticosteroids or platelet-rich plasma, which provide short-term pain relief but do not repair the underlying pathology of chronic tendon degeneration and risk of re-injury.
Surgery is expensive and is not always effective. In addition, there are lengthy recovery periods of up to six months. The treatment Orthocell is exploring will prove more cost-effective and reliable, and less intrusive.
Healthy final quarter
As a result of this progress, Orthocell expects to report top line results in the final quarter of 2021. It is placed 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 company’s market sizing suggests that the US market alone could number in the order of 470,000 patients per year, or US$2.8 billion.
Orthocell is also modelling economic savings the technology promises in terms of return to work and reduction in strain on the health system.