- Orthocell’s CelGro clinical trial patients all reported regaining normal shoulder function following CelGro surgery
- A total of 89 per cent of patients reported returning to work and everyday activities, pain-free
- CelGro strengthens rotator cuff tendon repair in the shoulder
- Regulatory approval for CelGro has recently been granted in Europe and Orthocell is moving towards first approval in the U.S.
Orthocell has announced final results from patients who completed the CelGro tendon regeneration clinical trial.
CelGro is a collagen medical device which helps with tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications.
The study was designed to assess the performance of CelGro during surgical repair of rotator cuff tendinopathy and tear.
All patients who completed the trial showed that CelGro guides and strengthens tendon healing when used during surgical repair. A total of 89 per cent of patients reported returning to work and every day activities, pain-free.
Importantly, there weren’t any adverse events or side-effects related to CelGro, in any participant.
A clinical follow-up trial two years after surgery found all patients achieved successful tendon repair and none required further surgery for a re-tear of the rotator cuff tendon. This is a significant finding as revision surgeries for re-tears is reported to occur in up to 57 per cent of cases.
These patients had previously suffered full thickness tears of the rotator cuff tendon in the shoulder following work-related, motor vehicle or sporting incidents. Their injuries led them to experience chronic pain and difficulty performing day-to-day activities such as sleeping, bathing and dressing.
The clinical trial and follow-up were conducted with Professor Allan Wang of St John of God Hospital, a leading orthopaedic surgeon, and Professor Ming Hao Zheng of the University of Western Australia.
“An effective biological augment to surgical repair is increasingly desired by the orthopaedic community. CelGro has shown to improve tissue healing and may assist in reducing the surgical revision rate of the rotator cuff tendon,” Allan said.
Over 500,000 rotator cuff surgical procedures are performed annually in the U.S. alone. CelGro’s global addressable market (in rotator cuff tendon only) is estimated to be worth approximately US$1 billion per annum. This indicates there is a huge market which can benefit from CelGro.
Orthocell recently received European regulatory approval for CelGro. The collagen medical device can now be marketed and sold within the European Union for a range of procedures.
“CelGro is proving to be a breakthrough soft tissue reconstruction platform technology with positive data announced now in nerve, tendon and bone applications,” Orthocell Managing Director Paul Anderson said.
Orthocell plans to continue commercialising CelGro and is moving towards receiving first approval in the U.S.