• First commercial sales of Remplir completed in Canada, marking a key milestone
• Follows Canadian regulatory approval and market launch activities in CY25
• Highlights the effectiveness of Orthocell's distributor-led model for efficient market entry

Orthocell Limited (ASX: OCC) has announced the first commercial sales of its Remplir nerve repair device in the Canadian market, valued at approximately US$75 million. This milestone follows regulatory approval from Health Canada for Remplir and the appointment of distributors in 2H CY25, which currently provide majority national coverage across the Canadian market. Orthocell has worked alongside its distributors on initial launch activities, including a KOL-led product roadshow across Canada. The commencement of commercial revenue generation in Canada reflects the effectiveness of Orthocell's distributor-led model, enabling efficient and capital-light market entry across non-U.S. markets. Orthocell continues to execute its distributor-led commercialization program across key non-U.S. markets, including Canada, Hong Kong, Singapore and Australia, while prioritizing internal resources on the U.S. market, valued at approximately US$1.6 billion. Recent approvals provide access to U.S. Department of Defense hospital networks, including approximately 221 military medical centres, alongside broader access to approximately 115 general U.S. hospitals, with the total network continuing to expand. Orthocell remains well funded, with over A$48 million in cash as at 31 March 2026 and no debt, supporting continued commercial expansion and enabling the company to capitalize on expanded U.S. hospital access and drive increased utilization of Remplir across key healthcare segments, including military.

The company remains well funded, with over A$48 million in cash as at 31 March 2026 and no debt, supporting continued commercial expansion and enabling Orthocell to capitalize on expanded U.S. hospital access and drive increased utilization of Remplir across key healthcare segments, including military.

Orthocell will continue to execute its distributor-led commercialization program across key non-U.S. markets, while focusing internal resources on the Company-led U.S. market, where recent approvals provide access to a growing network of ~336 hospitals, including 221 U.S. military medical centres. The company expects increasing surgeon engagement to support continued adoption and further revenue growth in the Canadian market.