• Growing international revenues, targeting large under-penetrated markets
• Compelling supportive clinical data for best-in-class platform for Bone, Nerve and Tendon repair
• Remplir US strategy on-track with clear path to breakeven

Orthocell Ltd, a leading medical device company, has reported its Q3 FY26 results, showcasing strong operational and financial performance. The company has maintained constant growth over the last three halves, driven by device sales, with its best-in-class platform for Bone, Nerve and Tendon repair approved in nine jurisdictions. The Remplir US strategy is on-track, with market access activities progressing as planned and sales continuing to build. The company has sufficient cash and a clear strategy to achieve the required less than 1% U.S. market share to reach profitability. Key highlights for the quarter include Remplir US demonstrating strong growth, real-world use in defence settings, and first sales in Canada. The company also appointed an exclusive distributor for the UK market. Financially, the company reported Q3 revenue of $3.2 million, a 45% increase on the prior corresponding period, and year-to-date revenue of $9.4 million, already exceeding the full-year FY25 revenue. The company has robust cash reserves of $48 million, providing a 4.6-year cash runway to support continued commercial expansion and R&D activities.

Orthocell is targeting 10,000 units in annual U.S. sales, requiring 300-400 surgeons performing around 6,000 procedures. This level of U.S. market share, less than 1%, is expected to achieve cash flow breakeven for the company.

Orthocell is focused on winning in the Americas, advancing its product pipeline, and building a global footprint with its collagen medical devices. The company is also continuing growth in Australia, New Zealand, and Asia.