• Orthocell granted license by Hong Kong Department of Health to sell Remplir nerve repair product
• Approval received 1 month after submission, ahead of initial 4Q CY25 expectation
• Hong Kong is a strategically valuable APAC market for Remplir

Orthocell Limited has received a license from the Hong Kong Department of Health's Medical Device Division to commence sales of its flagship nerve repair product Remplir in the Hong Kong market. The approval was received approximately one month following the regulatory submission on 10 April 2025, demonstrating the quality of the product and its clinical data. Hong Kong is considered a strategically valuable market in the APAC region as a recognized leader in medical services across Asia. Orthocell has now built a significant portfolio of Remplir regulatory approvals in the region, with Australia, New Zealand, Singapore and Thailand already in place, as well as approvals in the US and Canada. In aggregate, the markets in which Remplir is approved represent a total addressable market (TAM) of approximately US$1.8 billion. Orthocell intends to appoint a local, on-the-ground specialist distributor to drive sales in Hong Kong, leveraging its experience working with local distributors across multiple global jurisdictions. The company's focus remains on the US$1.6 billion US market, with internal resources primarily dedicated to the Remplir rollout in the US, while using specialist in-country distributors in other markets.

Orthocell is targeting a large global addressable nerve repair market estimated to be worth in excess of US$3.5 billion, with an estimated ~2.0M peripheral nerve repairs performed across Australia/New Zealand, Singapore, USA, EU/UK, Canada, Brazil, Japan, Hong Kong and Thailand.

Orthocell is well funded with A$31.7 million cash at bank as at 31 March 2025 and no debt, and is focused on continuing to broaden its commercial footprint and grow revenues in existing and new markets for its Remplir and other product portfolios.