• Orthocell achieved record revenue of $9.23m for FY25, up 36.4%
• Remplir nerve repair device gained US FDA 510(k) clearance, now approved in 7 markets
• Strong balance sheet with $28.6m cash, no debt or royalties

Orthocell Ltd (ASX:OCC), a regenerative medicine company, has reported its FY25 results, highlighting significant progress and growth across its product portfolio. The company achieved record revenue of $9.23m for the full year, an increase of 36.4% from the previous year. This strong financial performance was driven by the continued global expansion of Orthocell's products, particularly its flagship nerve repair device Remplir. In a major milestone, Remplir received US FDA 510(k) clearance in April 2025, providing access to the US$1.6 billion US nerve repair market. Orthocell had anticipated this approval and invested in surgeon engagement, distributor networks, and operational readiness, allowing the company to quickly commence sales in the US following clearance. Remplir is now approved for sale in a total of 7 major markets, including Australia, New Zealand, Singapore, the US, Canada, Thailand, and Hong Kong. Orthocell's balance sheet remains strong, with cash reserves of $28.6m as of 30 June 2025, up 38.8% from the previous year. The company has no debt and no royalty obligations, providing financial flexibility to support the continued global commercialization of Remplir and its other regenerative medicine products. Orthocell's manufacturing facility in Perth, Western Australia, which is certified to ISO 13485 standards, continues to produce and export the company's products to international markets. The company is well-positioned to capture a significant share of the combined US$4 billion addressable market for bone and nerve repair.

Orthocell reported record revenue of $9.23m for the full year ended 30 June 2025, an increase of 36.4% from the previous year. The company expects continued quarterly revenue growth as it expands the global commercialization of its Remplir nerve repair device, particularly in the US market following its recent FDA clearance.

Orthocell is focused on driving adoption of its Remplir nerve repair device in the US market, where it sees significant growth potential. The company has established a strong distributor network and experienced US leadership team to support the product's rollout and conversion of initial cases into sustained market share. Orthocell will also continue to expand the global footprint of its regenerative medicine portfolio, including its Striate+ dental membrane, to capture a larger share of the combined US$4 billion addressable market for bone and nerve repair.