Orthocell Ltd (ASX:OCC, OTC:ORHHF) has delivered record half-year revenue and gross profit, as its flagship nerve repair product Remplir™ gathers momentum in the United States and the company accelerates its international expansion.
For the six months to December 31, 2025, the regenerative medicine group reported revenue of $6.2 million, up 48% on the prior corresponding period. The result included two consecutive record quarters, with $3.0 million in 1Q FY26 and $3.2 million in 2Q FY26, and reflects a compound half-year growth rate of 21% since 2H FY24.
Half-year revenue growth.
Gross profit rose 63% to $3.0 million, with gross margin improving to 55% from 50% a year earlier. The margin uplift was driven by operating cost efficiencies and a higher contribution from Remplir™, which carries stronger margins than the company’s dental membrane product Striate+™.
Loss after income tax widened to $5.2 million, compared with $1.3 million in 1H FY25, reflecting planned investment to support global scale-up. Orthocell spent $2.0 million building its US sales, marketing and medical education capability, alongside investment in automation, enterprise systems and other one-off costs.
Net cash outflows from operating activities totalled $13.5 million for the half, while cash receipts from customers increased 47% to $3.6 million. Following a $30 million institutional placement completed during the period, Orthocell held $49.4 million in cash at December 31, 2025, and expects its balance to remain above the high-$20 million range as it moves towards profitability.
US commercialisation building
The US rollout of Remplir remains central to Orthocell’s growth strategy. The product is now approved for sale in 45 states, with the remaining five expected to be cleared by the third quarter of FY26.
The company has lodged 78 Value Analysis Committee (VAC) submissions with US hospitals, securing 27 approvals and establishing 19 active accounts. Orthocell expects revenue momentum to strengthen as more VAC approvals convert into routine usage.
In parallel, the company is expanding the clinical footprint of Remplir into nerve-sparing prostate surgery, targeting a reduction in post-prostatectomy erectile dysfunction and urinary incontinence. Additional studies are under way to support a planned US launch in this indication, with no further FDA approvals required and initial clinical data expected in 2H FY26.
Canada, Europe and Asia in focus
Orthocell has secured national distribution in Canada, appointing exclusive distributors across all provinces. First Canadian sales are expected in the first half of calendar 2026, with the market estimated at around US$75 million.
In Europe and the UK, the company submitted its regulatory application in December 2025, targeting entry into an estimated US$750 million nerve repair market. Approval is anticipated in the third quarter of calendar 2026.
Domestically, performance across Australia and New Zealand remained strong, supported by distributor Device Technologies and growing surgeon adoption. A distributor has also been appointed in Hong Kong, where the first surgical case has been completed, providing access to the Greater Bay Area.
Portfolio expansion and leadership
Beyond Remplir and Striate+, Orthocell is broadening its portfolio through PearlBone™, securing global distribution rights via an increased 12% shareholding in Marine Biomedical. A 510(k) application for PearlBone has been submitted to the US Food and Drug Administration post period-end.
“The first half of FY26 has delivered strong progress across key metrics, including revenues, US commercial traction, expansion into Canada and Hong Kong, regulatory advancement into Europe, and a strengthened balance sheet following the company’s successful $30 million capital raise,” chair John Van Der Wielen said.
“With $49.4 million in cash as at 31 December 2025 and accelerating global demand for Remplir, the company is confident it is well positioned to execute its international commercialisation strategy throughout 2026 and beyond.”