Regenerative medicine company Orthocell Ltd (ASX:OCC, OTC:ORHHF) has applied to the Therapeutic Goods Administration (TGA) for market approval of its SmrtGraft™ tendon repair device in Australia.
Reduced rate of treatment failure
This regulatory application follows positive results from a tendon regeneration study, which indicated that SmrtGraft reduces the rate of treatment failure and the need for revision surgeries.
SmrtGraft, designed for tendon repair and regeneration, will be the third revenue-generating product launched by Orthocell.
Orthocell’s existing products, Striate+™, for dental bone regeneration, and Remplir™, for peripheral nerve repair, are already on the market.
The study, published in the Journal of Orthopaedic Translation in 2021, assessed the safety and effectiveness of SmrtGraft in augmenting the surgical repair of rotator cuff tendons.
It involved 18 patients who had suffered full-thickness tears of the rotator cuff tendon due to work-related, motor vehicle or sporting incidents.
Improvements in quality of life
All patients experienced significant improvements in pain, function and quality of life, with no re-tears reported.
CEO 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.”
The SmrtGraft study demonstrated that the product can reduce the high re-tear rate associated with large rotator cuff repairs, which can reach up to 57%.
While the study focused on rotator cuff tendons, SmrtGraft has potential applications in multiple tendon repairs, including the knee, hip, ankle, elbow, wrist and hands.
Large addressable market
The addressable market for SmrtGraft is estimated to be worth more than US$1.2 billion annually, with more than 800,000 surgical repairs of rotator cuff tendons performed each year in Australia, the United States and the European Union.
Orthocell’s SmrtGraft is manufactured at its Good Manufacturing Practice (GMP) facility in Western Australia using the company’s proprietary SMRT™ manufacturing technology.
The product is currently available under the TGA’s Special Access Scheme (SAS) and is awaiting listing on the Australian Register of Therapeutic Goods (ARTG).
Orthocell plans to roll out SmrtGraft in Australia initially, with subsequent approvals in other key markets to follow.