Orthocell Ltd ( ASX:OCC , OTC:ORHHF) closed the September quarter with revenue of A$3.6 million and continued growth in sales of its flagship nerve repair product, Remplir, supported by accelerating US adoption and expansion into new international markets.
US Remplir unit sales rose 25% quarter-on-quarter to 149 units, driving a 20% increase in global Remplir revenue, which now accounts for more than 40% of total quarterly revenue.
Total revenue was 19% higher than the previous corresponding quarter but 7% below the June quarter, primarily reflecting the timing of Striate+ revenue recognition.
US commercialisation builds
Orthocell continued expanding its US commercial platform during the quarter, with its distributor network now covering around 70% of the population, including Florida, California, Texas and New York.
The number of hospitals purchasing Remplir increased 13% to 79, while the number of surgeons using the product rose 22% to 93.
Value Analysis Committee approvals increased 25% to 55, with another 59 applications progressing through the approval process.
The company also signed its first US national contract and added three distributors and two direct sales team members during the quarter.
Chief executive officer and managing director Paul Anderson said the key commercial indicators were demonstrating growing adoption.
"Our primary focus remains the US Remplir rollout, where we continue to see positive momentum across key indicators, including distributor coverage, hospitals purchasing the product and surgeons using Remplir," he said.
Global expansion continues
Orthocell recorded its first commercial sales of Remplir in Thailand during the quarter, adding another market to its expanding international footprint.
The company is also preparing for entry into the UK and European markets, with regulatory clearance continuing to be targeted by the end of calendar 2026.
Remplir is now approved and selling across Australia, New Zealand, the US, Canada, Singapore, Hong Kong and Thailand.
The product has also been used in more than 300 Australian prostatectomy procedures.
Early data from five advanced prostate cancer patients showed encouraging functional recovery, including urinary continence improvements in 80% of patients and return of erectile function in 75% of those who had function before surgery.
Financial position remains strong
Orthocell ended September with A$39 million in available funds, comprising A$5.2 million in cash and cash equivalents and A$33.8 million in securities and term deposits.
Operating cash outflow was A$4.5 million, or A$3.9 million after adjusting for A$0.6 million of non-recurring expenditure.
Customer receipts increased to A$2.6 million from A$2.5 million in the previous quarter.
Orthocell said no additional funding is currently anticipated to support Remplir commercialisation, planned capital investment and research and development activities as it progresses towards profitability.
Looking ahead
Orthocell will focus on increasing repeat Remplir use across existing US accounts, securing further hospital approvals and expanding surgeon adoption.
Near-term catalysts include expected UK and European regulatory clearance, further US commercial updates and additional clinical evidence supporting Remplir's use in nerve repair and prostatectomy procedures.
