Orthocell Ltd (ASX:OCC, OTC:ORHHF) delivered record quarterly revenue of A$3 million for the three months to September 30, 2025, up 11% on the June quarter and marking a sixth consecutive record, underpinned by Remplir’s growth in Australia and Singapore. The company closed the quarter with A$27 million in cash and said United States commercialisation is ahead of schedule.
The September result represents an 11% increase over the previous A$2.7 million record and reflects an 11% compound quarterly growth rate since the second quarter of financial year 2024. Material revenue from United States Remplir sales is expected to build during the December 2025 quarter and into the second half of financial year 2026.
Quarterly revenue.
North American distributor network established
In the United States nerve repair market, estimated at US$1.6 billion, Orthocell has established a specialist distributor network across 25 states covering 40% of the population; completed first surgeries at multiple hospitals; introduced the product to more than 100 surgeons; contracted 14 Medical Advisory Board members; submitted 51 Value Analysis Committee applications with 11 approvals to date; and is progressing state licences.
In Canada (estimated market size US$75 million), Orthocell appointed its first Remplir distributor with exclusivity in Alberta and British Columbia, with additional provinces targeted and first sales aimed for the December 2025 quarter.
“We have continued to build strong commercial momentum in the September quarter with another record quarter of sales revenue delivered primarily from Remplir sales in our existing markets in Australia and Singapore,’ Orthocell CEO and MD, Paul Anderson, said.
“The US rollout of Remplir remains a central operational focus and pleasingly we’re well ahead of schedule in this regard. We’ve seen the first revenue contributions from the US during the quarter from our early surgical cases, and we expect that to build during the December 2025 Quarter and grow into the second half of the financial year.
“The appointment of our first distributor in Canada is also a significant step forward in our North American Remplir commercialisation. There are very good synergies for us in that market with our on-the-ground team already in place in the US.”
Lab momentum
Clinical momentum included Remplir’s use in nerve-sparing prostate cancer surgery (40 Australian cases; initial data due Q4 calendar year 2025) and study results showing an 81% success rate with no complications or adverse reactions.
“We’re also very excited about the prospects for the use of Remplir in nerve-sparing prostate cancer surgeries. Prostate cancer remains the most diagnosed cancer among men globally and this promising new application has the potential to significantly grow our Total Addressable Market,” Anderson said.
Executive additions included Jim Piper (chief financial officer), Adam Wood (chief commercial officer) and Michael McNulty (non-executive director).