Orthocell has applied to the Therapeutic Good Administration (TGA) for Australian market approval for its SmrtGraft™ tendon repair device, in preparation for its introduction into the Australian tendon repair and regeneration market.
The regulatory application follows positive results from Orthocell’s tendon regeneration study, indicating that SmrtGraft reduces the rate of treatment failure and the need for revision surgeries. The results from this study were published in the highly regarded Journal of Orthopaedic Translation in 2021.
Orthocell Managing Director, Paul Anderson, said:
“We are delighted to announce the Australian regulatory application for our SmrtGraft tendon repair product. Australia is an important stepping stone to other very large and attractive international target markets, including the USA. This is another significant milestone in our product expansion strategy. Once approved, it will be Orthocell’s third revenue generating medical device available in Australia.”
SmrtGraft will be the third revenue generating product to be launched by the Company.
The significant addressable market for SmrtGraft, is estimated to be worth more than US$1.2 billion annually, with >800,000 surgical repairs of rotator cuff tendons alone completed in just the AUS, USA and EU per year.