Orthocell’s flagship Remplir nerve-repair product gained ground in the US and Thailand during the September quarter, even as total revenue slipped from the June period. The company reported A$39 million in available funds and said it does not currently expect to raise additional capital.
- US Remplir unit sales rose 25% to 149 in the September quarter
- Global Remplir revenue increased 20% quarter on quarter and exceeded 40% of total revenue
- Adoption expanded to 79 US hospitals and 93 surgeons
- First Remplir sales were recorded in Thailand
- A$39 million available funds included A$33.8 million in securities and term deposits
Remplir adoption grows despite softer total revenue
Orthocell Limited (ASX:OCC) is turning a widening US commercial footprint into stronger Remplir usage, with unit sales up 25% to 149 in the September quarter. Global Remplir revenue rose 20% from the previous quarter and now accounts for more than 40% of quarterly revenue, giving the nerve-repair product a growing role in the company’s sales mix.
Total revenue was A$3.6 million, up 19% on the previous corresponding quarter but down 7% from A$3.8 million in June. Orthocell said the sequential decline primarily reflected the timing of Striate+ revenue recognition rather than a reversal in Remplir momentum. US Remplir revenue reached A$0.40 million, compared with A$0.33 million in the previous quarter.
The commercial indicators are moving in the same direction. Remplir was being purchased by 79 US hospitals, up 13% during the quarter, while the number of surgeons using it rose 22% to 93. Value Analysis Committee approvals increased 25% to 55, with another 59 applications progressing through hospital approval processes.
US distribution reaches four major states
Orthocell now has distributors covering approximately 70% of the US population, including Florida, California, Texas and New York. The company said it added three distributors and two direct sales team members during the quarter, signed its first US national contract and recorded 10 direct replenishment orders from six hospitals. Repeat usage accounted for 78% of US unit sales, according to the investor presentation.
The rollout builds on the earlier FY26 Remplir growth, which included expanding US hospital and surgeon adoption alongside investment in manufacturing capacity. Orthocell completed 15 medical education events in the latest quarter, including seven cadaver laboratories, four journal clubs and three conferences, as it sought to increase surgeon familiarity and product use.
Thailand launch opens another approved market
Remplir also generated its first commercial sales in Thailand, a market Orthocell estimates at US$84 million. The product is now approved and selling in seven countries, while preparations continue for a UK and European Union launch. Regulatory clearance in those markets remains expected by the end of calendar 2026, rather than being completed, and Orthocell is working with key opinion leaders and UK distributor LEDA Orthopaedics ahead of that decision.
Clinical evidence is expanding in a separate potential use for Remplir. In a five-patient series involving advanced prostate cancer patients undergoing robotic-assisted radical prostatectomy, the device was implanted in every procedure without reported technical difficulties or device-related complications. Four patients showed encouraging urinary continence outcomes, including three who were pad-free by six months, while three of the four patients with erectile function before surgery regained function. The small, uncontrolled cohort is preliminary; Orthocell said it will use the findings to inform a prospective clinical trial.
Funding supports commercialisation but cash accounting matters
Orthocell ended September with A$39.0 million in available funds, comprising A$5.2 million in cash and cash equivalents and A$33.8 million in securities and term deposits maturing over three to 12 months. Operating cash outflow was A$4.5 million, or A$3.9 million after A$0.6 million of non-recurring expenditure. Management said cash consumption is expected to decline as Remplir sales grow and that no additional funding is currently anticipated.
There is, however, an important distinction between the headline reserve figure and immediately available cash. The Appendix 4C calculates only 1.2 quarters of funding using A$5.2 million of cash, while management says the term deposits mature throughout 2026 and 2027 and provide sufficient liquidity, equivalent to eight quarters of operational funding on its stated basis. The next quarterly update will therefore be important not only for sales conversion, but also for whether repeat Remplir usage begins to reduce the company’s underlying cash burn.
Bottom Line?
The commercial story is improving, but the investment case still depends on turning hospital access and surgeon interest into repeat procedure volumes before the cash runway becomes a sharper issue.
Questions in the middle?
- How quickly will the 59 pending hospital approvals convert into regular Remplir orders?
- Can repeat US procedure volumes push normalised operating cash use materially lower?
- Will UK and EU clearance arrive by the end of calendar 2026 and broaden sales momentum?