Orthocell Ltd (ASX:OCC, OTC:ORHHF) has posted record quarterly and full-year revenue, with accelerating adoption of its Remplir™ nerve repair device in Australia and the United States strengthening the regenerative medicine company’s commercial growth outlook.
Revenue reached A$3.8 million in the June quarter, up 20% from the March period and 36% on the corresponding quarter last year. FY2026 revenue increased 44% to a record A$13.2 million, supported by growing sales of Remplir and Striate+™ across domestic and international markets.
The June result marked Orthocell’s highest quarterly revenue to date and extended a three-year growth trend, with quarterly revenue increasing at a compound rate of 10% over the past 10 quarters.
Quarterly Revenue Growth
US commercialisation gains moment
Orthocell said the US rollout of Remplir continued to track ahead of expectations, with improvements across hospital access, surgeon adoption and distributor coverage.
US Remplir sales reached A$330,000 during the quarter, representing a 10% increase from the March period. The company’s distributor network now covers about 50% of the US population, providing a broader platform for hospital engagement and surgeon education.
The number of hospitals purchasing Remplir increased 27% during the quarter to 70, while the number of surgeons using the device rose 55% to 76. Unit sales totalled 119.
Value Analysis Committee approvals increased 38% to 44, expanding Remplir’s access to 151 hospitals, with another 64 applications progressing through the approval process.
Orthocell also received approval for Remplir across the US Department of Defence and Veterans Affairs healthcare networks, providing potential access to 221 military and veterans’ medical centres.
Chief executive officer and managing director Paul Anderson said the results reflected continued execution of the company’s global commercialisation strategy.
“Our record FY2026 results reflect the successful execution of Orthocell Limited’s global commercialisation strategy, with strong momentum across Australia and early scale-up in the United States,” he said.
“US surgeon adoption and hospital engagement continue to build, and we expect this to be a key driver of revenue growth as our distribution footprint expands.”
Strong liquidity supports growth plans
Orthocell ended June with A$44.1 million in available funds, comprising A$9.4 million in cash and cash equivalents and A$34.7 million in securities and term deposits.
The company said its liquidity position was sufficient to support US commercialisation, regulatory initiatives, manufacturing expansion and strategic growth opportunities without requiring additional funding.
Customer receipts increased to A$2.5 million from A$1.6 million in the previous quarter. Reported operating cash burn was A$3.6 million, compared with a small inflow in the March quarter, which had benefited from a A$3 million R&D tax refund.
After adjusting for the tax incentive and non-recurring expenditure, normalised operating cash burn was broadly stable at A$2.4 million, compared with A$2.5 million in the prior quarter.
Orthocell is continuing to invest in commercial execution, research and development, manufacturing capacity and production efficiencies as it works toward cash flow breakeven.
International rollout broadens
International Remplir sales now account for more than 9% of quarterly revenue, with the company targeting further expansion through recently appointed distributors in Canada and Thailand.
Orthocell also expects sales in the UK and European Union to begin in the first half of 2027, subject to regulatory clearance.
Its submission to the British Standards Institution remains on schedule, with UK and EU approval anticipated by the end of calendar 2026. Orthocell estimates the addressable peripheral nerve repair market in those regions at about US$750 million.
The company also expanded the reach of Remplir through a humanitarian initiative supplying devices to Ukraine for the treatment of complex battlefield and civilian trauma injuries.
Prostate surgery and Striate+ opportunities grow
More than 250 nerve-sparing prostate cancer procedures using Remplir have now been completed by 39 surgeons across Australia’s five most populous states.
Orthocell believes the indication could increase Remplir’s total addressable US market from US$1.6 billion to about US$2 billion. Clinical performance data is being compiled, with an update expected following publication of a surgeon-led academic paper in the second half of 2026.
Meanwhile, Striate+ received regulatory approval in Colombia and Ecuador. Commercial launches in Brazil, Colombia and Ecuador are expected during the second half of 2026 through global distribution partner BioHorizons.
What’s ahead
Orthocell will focus on expanding US hospital penetration, increasing repeat surgeon use and progressing Remplir toward UK and EU approval.
The company has also started a US regulatory program for a tendon repair product based on its collagen technology platform, creating another potential growth avenue alongside Remplir and Striate+.