• US Remplir strategy on-track with market access activities progressing as planned
• Fully funded and investing in growth to reach profitability
• Significant US market opportunity with over 700,000 peripheral nerve repair procedures annually

Orthocell Ltd, an Australian medical technology company, has provided an update on its US market and operational progress. The company's US Remplir strategy is on-track, with market access activities clearly defined and execution progressing as planned. Sales of Remplir in the US are continuing to build, and Orthocell is fully funded and investing in growth to reach profitability. The company estimates that it requires approximately 10,000 Remplir unit sales per annum in the US to reach cash breakeven, which is less than 1% of the addressable market. Orthocell has a three-year vision to be at the forefront of regenerative medicine innovation, advancing toward ASX 300 inclusion through disciplined growth and a sustainable, well-funded product pipeline. The company's focus in FY26 includes gaining market access and growing the customer base of Remplir in the US, strategic Asia expansion, and completing UK and EU launch planning. Orthocell has maintained constant revenue growth over the last three half-years, driven by device sales. The company is investing in growth, including deploying capital raising funds to grow capability in the US and manufacturing capacity. Orthocell has a dedicated US team to support scaled growth, with a focus on areas such as medical education, clinical affairs, marketing, and sales. The company is also expanding its manufacturing capacity to deliver the volumes estimated and reduce the cost of sales.

Orthocell estimates that it requires approximately 10,000 Remplir unit sales per annum in the US to reach cash breakeven, which is less than 1% of the addressable market.