• Record revenue of $9.19m for FY2025, up 35.8% on previous year
• Remplir nerve repair product cleared for US launch, first US surgical use completed
• Regulatory approvals received for Remplir in Hong Kong, Thailand, and Canada

Orthocell Limited (ASX: OCC) has reported record annual revenue of $9.19 million for FY2025, up 35.8% on the previous financial year, and quarterly revenue of $2.73 million for the June 2025 quarter, up 22.8% on the previous quarterly record. This exceptional growth has been driven by strong sales of the company's flagship nerve repair product Remplir in existing markets. Orthocell has also made significant progress in its US launch plans for Remplir, receiving FDA 510(k) clearance in April 2025 and completing the first surgical use of the product in the US in late June. The company has rapidly established a growing US distributor network of 14 specialist nerve distributors and built up significant Remplir inventory in preparation for the US rollout. Orthocell also received regulatory approvals to commence sales of Remplir in the strategically important markets of Hong Kong, Thailand, and Canada during the quarter. Additionally, the company's dental guided bone regeneration product Striate+ received regulatory approval in Brazil, a key part of the wider $735 million global market the company is targeting. Orthocell remains well-capitalized with $28.6 million in cash at the end of the quarter, positioning the company to continue the global commercialization of its products.

Orthocell reported record annual revenue of $9.19 million for FY2025, up 35.8% on the previous financial year, and quarterly revenue of $2.73 million for the June 2025 quarter, up 22.8% on the previous quarterly record. The company is well-positioned to generate first US sales of its Remplir nerve repair product following FDA clearance and successful first surgical use in the US market.

Orthocell is well-placed to generate first US sales of its Remplir nerve repair product, with a US logistics and customer service partner in place, sales pathways established, and significant Remplir inventory built up. The company expects sales in the US market to ramp up over the coming quarters, providing a step change in revenue.