Orthocell has released its half-year financial report for the six months to 31 December 2025, reflecting strong operational progress and continued execution of its global expansion strategy.
Key highlights include:
- Record 1H FY26 revenue of $6.2 million, up 48% on prior corresponding period
- Gross profit of $3.0 million in 1H FY26, up 63% on the prior corresponding period
- US commercial launch progressing to plan, with Remplir™ now approved for sale in 45 states
- Canadian national distribution secured, with exclusive distributors appointed across all provinces; first Canadian sales expected in 1Q CY26
- Continued strong domestic performance in Australia and New Zealand, with record revenue growth and expanding surgeon adoption; Hong Kong distributor appointed with first surgical case completed.
- Expansion into nerve-sparing prostate surgery, with growing adoption in Australia and significant global market potential; further studies underway to support a planned US launch (no additional FDA approvals required), with initial clinical data expected in 2H FY26.
- EU and UK regulatory application submitted targeting entry into an estimated US$750m nerve repair market; approval anticipated in 3Q CY26.
- Portfolio expansion through bone regeneration technology PearlBone™
- Strongly capitalised and leadership strengthened, with $49.4 million cash reserves at 31 December 2025
Orthocell Chair, John Van Der Wielen, said:
“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. With $49.4 million in cash as reserves 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.”