Orthocell has received regulatory approval from the Hong Kong Department of Health’s Medical Device Division to commence sales of Remplir™ in the Hong Kong nerve repair market.
This approval was received well ahead of initial expectations.
Hong Kong is considered a strategically valuable addition to the Remplir global footprint, with the country recognised as a leader in medical services across Asia.
This builds on significant recent momentum of regulatory approvals for Remplir in the US, Thailand and Canada in April 2025, in addition to Australia, New Zealand and Singapore. The markets in which Remplir is now approved represent a Total Addressable Market of approximately US$1.8 billion.
Orthocell CEO and MD, Paul Anderson, said:
“We are now building a strategically valuable portfolio of approvals for Remplir spanning the Asia Pacific region and North America. We believe each additional country adds to the overall strategic value of our product portfolio.
“We’ve experienced rapid growth in 2025 in the number of countries in which Remplir is approved and our focus is moving towards converting those approvals into sales.”