Orthocell reports record revenue, US market entry for Remplir

Orthocell reported a record revenue of A$9.23 million for FY25, representing a 36.4% increase from the previous financial year (A$6.76 million in FY24), with the June quarter contributing A$2.75 million. The company's cash reserves increased to A$28.6 million, up 38.8% from A$20.6 million in the prior year. Orthocell secured US FDA 510(k) clearance for its Remplir nerve repair device in April 2025, gaining access to the $1.6 bn U.S. nerve repair market, with first sales expected to gain momentum in 1H FY26.

Beyond the US, Remplir also received regulatory approvals in Canada, Hong Kong, Singapore, and Thailand. The Striate+ dental membrane expanded its global footprint with approvals in Canada, Brazil, Singapore, and the DACH region of Europe, contributing to a combined addressable market of over $4 bn annually across bone and nerve repair. Orthocell maintains a strong balance sheet with no debt or royalties payable on product sales.

A A$17 million placement was completed during the year to accelerate global growth, focusing on the Remplir US commercial launch and expanding sales in newly approved markets. As of 30 June 2025, ten Remplir surgeries have taken place in the US, with 14 specialist distributors covering over 25 US states.