Orthocell’s US Rollout of Remplir™ Begins Amid Competitive Nerve Repair Market Risks

Record Revenue Highlights Growing Market Traction

Orthocell Limited has delivered a landmark financial performance for FY2025, posting record revenue of A$9.19 million, a 35.8% increase over the previous year. The June quarter alone saw revenue climb 22.8% to A$2.73 million, marking the fifth consecutive quarter of record sales. This growth underscores the expanding adoption of Orthocell’s flagship nerve repair product, Remplir™, particularly in its home market of Australia.

US Market Entry Accelerates Post FDA Clearance

The quarter was defined by Orthocell’s successful US FDA 510(k) clearance for Remplir™ in April 2025, unlocking access to the substantial US$1.6 billion nerve repair market. Orthocell swiftly capitalised on this milestone, recording the first surgical use of Remplir™ in the US within three months. The company has established a robust distributor network comprising 14 specialist nerve repair partners spanning 25 states, positioning it well for a scalable commercial rollout.

Orthocell’s strategy balances internal resources with external distributors who maintain direct relationships with surgeons and hospitals, a model that has proven effective in Australia and is now being replicated in the US. The company has also built significant inventory and secured manufacturing capacity for 100,000 units annually, with modular expansion options to meet growing demand.

Expanding Global Footprint with Regulatory Approvals

Beyond the US, Orthocell has broadened its international reach with regulatory approvals for Remplir™ in Hong Kong, Thailand, and Canada. These markets will be served primarily through external specialist distributors, allowing Orthocell to maintain a lean internal footprint focused on the US launch.

In parallel, Orthocell’s dental product Striate+™ secured regulatory approval in Brazil, a key market estimated at US$65 million. This adds to an already extensive list of approved territories including the US, Europe, UK, Australia, New Zealand, Canada, and Singapore. The company is collaborating with its global distribution partner BioHorizons to initiate commercial sales of Striate+ in Brazil during the first half of 2026.

Strong Financial Position Fuels Growth Ambitions

Orthocell ended the quarter with a robust cash balance of A$28.6 million and no debt, up nearly 39% from the prior year. This strong financial footing supports ongoing commercialisation efforts, regulatory submissions, and research and development activities. The company’s cost-effective sales model and manufacturing efficiencies further underpin its growth trajectory.

Orthocell continues to advance clinical evidence supporting Remplir’s superior nerve regeneration outcomes and Striate+’s efficacy in dental bone regeneration, reinforcing its competitive positioning. The company’s leadership remains confident that the US market launch will be a significant catalyst for revenue growth in the coming quarters.