Orthocell Ltd has continued its global commercialisation push, preparing to enter the Thai market with a submission to the Thailand Food and Drug Administration (TFDA) for the sale of nerve repair product Remplir™.
The new regulatory submission follows continued record revenue growth due to strong sales in existing markets of Australia, New Zealand and Singapore.
The company says its rapid transition from regulatory approval to first sales in the Singapore market highlights the success of OCC’s accelerated expansion in the Asia-Pacific region – Orthocell is now considering opportunities in Hong King, Taiwan, Vietnam, Indonesia and the Philippines.
US and Canadian authorisations on track for 2025
Orthocell is also awaiting regulatory clearance in the form of the US FDA 510(k), which will allow the company to commercially distribute Remplir to the US market, representing a US$1.6 billion opportunity.
OCC expects to receive approval to begin commercial sales in March or April this year, and for the US$75 million Canadian market in the second half of 2025.
The company says its rapid global expansion will offer a sizeable opportunity to increase revenue. Orthocell is targeting a 20% share of the US$3.2 billion available in its selected markets.
OCC is confident it has enough cash in the bank to pursue its commercial ambitions, holding A$33 million as of the end of last.
The Remplir product is a collagen wrap used in nerve repair surgery to improve outcomes in the repair and regeneration of damaged nerves.
More than 180 orthopaedic and plastic surgeons are now using Remplir in peripheral nerve repair surgeries across Australia, New Zealand and Singapore.