US$90.2 million revenue and a 28% rise headline Saluda’s FY26

Growth delivered, but funding remains the central question

Saluda Medical, Inc. (ASX:SLD) ended its first full year as an ASX-listed company with strong commercial momentum, but not yet financial self-sufficiency. Revenue rose 28% to US$90.2 million in FY26, 4% above upgraded guidance, while the annual report states that substantial doubt exists about the company’s ability to continue as a going concern without further funding. The result builds on the earlier FY26 revenue result, which reported the same revenue growth and flagged the funding issue.

Management forecasts that existing cash should cover substantially all of the 12-month assessment period, but says additional capital may be required towards its end. The company had US$116.4 million in cash and cash equivalents at June 30, plus US$2.2 million of restricted cash. It also reported US$25 million of undrawn debt capacity, although that facility was subject to conditions not met at the date the financial statements were issued and was therefore excluded from management’s liquidity assessment.

Revenue growth came with wider commercial reach

The operating numbers were encouraging. US revenue increased 27% to US$63.2 million, while international revenue rose 32% to US$26.9 million. U.S. implanted patients increased 34%, average active implanting physicians rose 21%, and active physician utilisation climbed 11%.

Saluda finished FY26 with 161 U.S. sales representatives, including an average of 89 fully trained representatives during the year. Yet the company says only about 4% of the existing U.S. spinal cord stimulation physician population was actively implanting the Evoke System at year-end, leaving adoption and utilisation as the main commercial levers in management’s plan.

CAP24 adds a new surgical market segment

FDA approval of the CAP24 paddle lead was the year’s most consequential product milestone. The lead allows Saluda to target surgical paddle lead procedures and broaden its reach to neurosurgeons and orthopaedic spine surgeons. The company estimates that this segment generated about US$670 million in U.S. revenue in 2024, representing roughly 30% of the total U.S. spinal cord stimulation market.

The approval was covered earlier in the CAP24 FDA approval, which described the phased U.S. launch and the product’s intended appeal to new surgical specialties. The annual report now places that opportunity alongside the global rollout of EVA, Saluda’s automated programming platform, which management says completed its rollout across commercial geographies during FY26.

Margins improved while losses remained substantial

Gross margin improved by 230 basis points to 48.9%, supported by growing commercial scale and operating execution. Cash used in operations narrowed modestly to US$116.0 million from US$118.2 million in FY25, but the company still recorded a US$149.6 million net loss and ended the year with an accumulated deficit of US$724.0 million.

Saluda’s FY27 guidance calls for revenue growth of 25% to 35%, gross margin of 50% to 52% and an adjusted EBITDA loss between US$101 million and US$95 million. The plan assumes revenue growth will begin to outpace operating expense growth as the sales force matures, while manufacturing efficiencies and product mix support further margin improvement.

New CEO inherits a scaling business and a cash clock

Michael Mathias became chief executive on September 6, 2026, succeeding Barry Regan after serving as Saluda’s chief commercial officer. The transition comes as the company begins its phased CAP24 launch and seeks to convert a wider physician base into recurring implant activity.

Saluda drew the second US$25 million tranche of its Perceptive term loan at year-end, taking gross debt to US$100 million before issuance costs. The loan matures in March 2030 and carries interest at 7.5% plus the greater of one-month Term SOFR or 3.5%. The balance sheet provides room to execute, but the auditor’s going-concern emphasis makes the timing and terms of any future financing a live issue rather than a footnote.