Why Saluda Medical (ASX:SLD) is backing a closed-loop paddle lead while managing a device field action

Sonal Goyal

03 November 2026 09:43 PM AEDT

Why Saluda Medical (ASX:SLD) is backing a closed-loop paddle lead while managing a device field action

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Key Highlights

Saluda Medical (ASX:SLD) said the FDA approved the CAP24 surgical paddle lead in late June 2026, with full US commercial release announced on 5 October 2026, addressing an estimated US$670 million US market segment.
FY26 Revenue grew 28% to US$90.2 million and gross Margin improved to 48.9%, while US implanted patients in the September quarter rose 55% year-on-year to 838.
A voluntary field action was announced on 21 October 2026 covering a defined group of Evoke stimulators affected by a third-party Manufacturing process change that can disrupt charging.
Cash fell to US$73.6 million at 30 September 2026 and management estimated a runway to about June 2027, making further funding a central near-term question.

Saluda Medical is betting that a surgical paddle lead able to read and respond to the body's own nerve signals will widen its share of the US spinal cord stimulation market. The US Food and Drug Administration approved the CAP24 paddle lead at the end of June 2026, and full US commercial release was announced on 5 October 2026. At the same time, the company is managing a voluntary field action and a falling cash balance.

What the company does and how it is quoted

Saluda Medical, Inc. (ASX:SLD) is a commercial-stage medical device company with a neuromodulation platform for chronic neurological conditions. Its first product is the Evoke System, a closed-loop spinal cord stimulator.

Australian investors hold CHESS Depositary Interests, or CDIs, which give beneficial ownership of shares in the US-based company. The ASX lists it under Health Care and in the S&P/ASX Emerging Companies Index.

Growth in FY26 and the first quarter

For the year to 30 June 2026 revenue was US$90.2 million, up 28 per cent on US$70.4 million. Gross margin improved to 48.9 per cent from 46.6 per cent. International revenue grew 32 per cent to US$26.9 million. The adjusted EBITDA loss was US$113.7 million and the loss from operations US$149.0 million.

In the September 2026 quarter revenue was US$23.1 million, up 26 per cent on the same quarter a year earlier but below the US$27.0 million of the June quarter, which the company attributes to seasonality. United States revenue rose 34 per cent to US$17.4 million, while international revenue of US$5.8 million rose only 7 per cent. Sales began in Austria during the quarter.

US implanted patients reached 838 in the quarter, up 55 per cent, and about 374 physicians were actively implanting.

Why CAP24 matters

Paddle leads are placed surgically, and the company estimates the segment generated about US$670 million of US revenue in 2024, roughly 30 per cent of the US market. Saluda describes CAP24 as the first FDA-approved surgical paddle lead delivering closed-loop, dose-controlled therapy.

That gives the sales force a surgical option to offer alongside Evoke. About 75 per cent of that force is fully trained, and half of viable US territories have at least one fully trained representative. Its EVA automated programming tool is now in full commercial use in all commercial geographies.

Cash, funding and the field action

Cash fell to US$73.6 million at 30 September 2026 from US$116.4 million three months earlier. Operations used US$42.7 million, including about US$11.4 million of one-off or timing items such as annual incentives and executive retention payments. Management expects lower cash use for the rest of FY27 and estimates its runway at about June 2027, so further funding is likely to be a central question.

On 21 October 2026 the company announced a voluntary field action for a defined group of Evoke closed-loop stimulators. A third-party manufacturing process change can cause temporary unintended stimulation during charging, or stop an implanted device charging.

Among about 3,900 implanted devices in that group, 26 complaints have been reported over more than two years. Saluda is not recommending prophylactic replacement and does not expect a material effect on operations, but it is engaging with the FDA on classification.

What to watch

FY27 guidance, reaffirmed in the quarterly report, is revenue growth of 25 to 35 per cent, a gross margin of 50 to 52 per cent and an adjusted EBITDA loss of US$95 million to US$101 million.

Mike Mathias, who joined as Chief Commercial Officer in November 2024, was named chief executive on 7 September 2026.

Readers can follow sales force training, the pace of CAP24 adoption, the FDA's classification of the field action and any funding announcement. Debt is relevant: US$25 million was drawn from an existing Facility on 30 June 2026.

Word count (article body only, recounted by script; excludes headline, subheadings, sources and publishing notes): 600

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