Key Highlights

  • Orthocell reported revenue of A$3.6 million for the September 2026 quarter, up 19% on the previous corresponding quarter and down 7% on the June quarter.
  • US Remplir unit sales rose 25% to 149 from 119, with 79 hospitals purchasing and 93 surgeons using the product.
  • Funds available at 30 September 2026 were A$39.0 million, made up of A$5.2 million in cash and A$33.8 million in securities and term deposits.
  • Net operating cash outflow was A$4.5 million, or A$3.9 million after adjusting for A$0.6 million of non-recurring items.

Orthocell Limited (ASX:OCC) has reported revenue of $3.6 million for the quarter ended 30 September 2026, compared with $3.8 million in the June quarter. The figure was 19% above the previous corresponding quarter and 7% below the June quarter, a movement the company attributed mainly to the timing of Striate+ revenue recognition.

The regenerative medicine company said global revenue from its nerve repair product Remplir rose 20% on the previous quarter and now accounts for more than 40% of total quarterly revenue. US Remplir revenue reached $0.40 million.

US Commercialisation Metrics

US unit sales of Remplir increased 25% to 149 units, up from 119 in the previous quarter. The number of hospitals purchasing the product rose 13% to 79, and surgeons using it increased 22% to 93. Orthocell's distributor network now covers approximately 70% of the US population, including Florida, California, Texas and New York.

Value Analysis Committee approvals, which the company links to growing hospital access, rose 25% to 55, with a further 59 applications progressing through the approval process. The company also cited its first US national contract and approvals in two of the four largest US states.

Orthocell completed 15 medical education events during the period, comprising seven cadaver labs, four journal clubs and three conferences, and took part in the American Society for Surgery of the Hand conference. The quarter's compound quarterly growth rate over the last nine quarters was 8%.

Clinical Data and International Markets

Remplir has been used in more than 300 Australian prostatectomy procedures, and several surgeons have each performed more than 20. In five patients with advanced prostate cancer undergoing robotic-assisted radical prostatectomy, the device was implanted in all procedures with no reported technical difficulties or device-related complications. Of those patients, 80% showed encouraging urinary continence outcomes, including three who were pad-free by six months, and 75% of those with erectile function before surgery saw it return.

The findings will inform a planned prospective clinical trial. The company sized the opportunity at approximately 12,000 prostatectomy procedures a year in Australia and 115,000 in the United States, noting that no additional regulatory approvals are needed across the seven jurisdictions where Remplir is approved.

Orthocell also recorded first commercial sales of Remplir in Thailand, a nerve repair market it sizes at US$84 million. It continues to expect regulatory approval for the UK and EU market, which it sizes at US$750 million, by the end of calendar 2026, with preparatory work under way with LEDA Orthopaedics, its UK distributor.

Cash Flow and Funding

Cash receipts from customers, inclusive of GST, were $2.6 million against $2.5 million in the prior quarter. Net cash used in operating activities was $4.5 million, compared with $3.6 million previously, driven by higher spending on US commercialisation and the timing of supplier payments. Excluding $0.6 million of non-recurring expenditure, including prepayments and one-off activities, normalised operating cash use was $3.9 million.

The Appendix 4C shows marketing, business development and investor relations payments of $2.643 million, product manufacturing and operating overheads of $1.845 million, staff costs of $1.266 million and research and development of $1.011 million. Capital expenditure and leasing interest totalled $0.1 million against $1.0 million in the prior quarter, reflecting the staged manufacturing upgrade and the completion of the automation project.

Funds available at 30 September 2026 were $39.0 million, comprising $5.2 million in cash and cash equivalents and $33.8 million in securities and term deposits with maturities of three to 12 months. Cash and cash equivalents stood at $9.389 million at the start of the quarter. Payments to related parties were $450,000. Based on current expenditure levels, the company does not anticipate needing additional funding for Remplir commercialisation, planned capital investment and research.

Where the Numbers Leave the Company

The quarter combined lower total revenue than in June with higher Remplir volumes, a larger operating cash outflow and a reduction in capital spending. Revenue of $3.6 million sat alongside 149 US units, 79 hospitals and 93 surgeons, while operating cash outflow of $4.5 million was drawn from funds available of $39.0 million.

Management said the capital raising completed approximately 12 months earlier was designed to fund the business through the US ramp-up of Remplir.