Orthocell Limited (ASX: $OCC) has applied to the Therapeutic Good Administration (TGA) for Australian market approval for its SmrtGraftTM tendon repair device, following positive results from its tendon regeneration study. The product is intended for tendon repair and regeneration applications, and will be the company's third revenue generating product in addition to Striate+TM and Remplirâ„¢ already in the market.
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.
Orthocell Limited (ASX: $OCC) has submitted a TGA application for its SmrtGraftTM tendon repair device, targeting the tendon repair and regeneration market. The product, with positive results from its tendon regeneration study, is expected to reduce the rate of treatment failure and the need for revision surgeries. With a significant addressable market estimated to be worth more than US$1.2 billion annually, the company is strategically positioned to roll out its tendon and ligament repair devices, starting with Australia and expanding to other key regulatory jurisdictions. The company's ambitions to become a leading tendon repair device provider are evident, and the outlook for SmrtGraftTM looks promising as it aims to improve patient outcomes and address the unmet needs in tendon repair and regeneration applications.