Orthocell Ltd is advancing its commercial expansion in Asia with the submission of a regulatory application to the Hong Kong Department of Health’s Medical Device Division for its nerve repair product Remplir™.
The company anticipates that the approval will kick off sales for Remplir in the fourth quarter of calendar year 2025.
Remplir is a collagen wrap used in nerve repair surgery to assist surgeons in improving outcomes for the repair and regeneration of damaged nerves.
"Excellent Opportunity"
Orthocell CEO and MD Paul Anderson said: “Building on our early success in Singapore, we see an excellent opportunity for Remplir throughout Asian markets.
"We’ll continue to approach these markets using experienced on-the-ground distributors to market the product directly to customers, like we have done in Singapore.
"Not only does the distributor model provide a rapid path to sales, it is also cost efficient, enabling the company to focus on the market launch of Remplir into the globally significant US$1.6 billion1 US nerve repair market.”
Strong commercial traction
The move builds on strong commercial traction for Remplir™ in Australia, New Zealand and Singapore, and follows the recent milestone 510(k) clearance for distribution in the United States – a market valued at US$1.6 billion.
Rapid progress from regulatory approval to first sales in Singapore has provided a template for accelerated regional rollouts.
In addition to Hong Kong, Orthocell expects to receive approval to enter the Thai market, valued at approximately US$84 million, in the second quarter of calendar year 2025.
Market assessments are also underway for Taiwan, Vietnam, Indonesia and the Philippines as part of OCC's Asia-Pacific strategy.
US$3.2 billion opportunity
Orthocell is targeting a 20% market share across selected regions, which together represent a US$3.2 billion opportunity.
This global expansion is underpinned by a strong financial position, with approximately A$32 million in cash reserves to support ongoing market entry and sales growth initiatives.
Hong Kong has been identified as a key entry point due to its role as a regional medical hub.
The application complements Orthocell’s broader regulatory program in Asia, with the company focused on bringing Remplir™ to new markets in a timely and capital-efficient manner.