Highlights

  • Saluda Medical (ASX:SLD) reported FY26 Revenue of US$90.2 million and a gross Margin of 48.9%.
  • Mike Mathias was appointed chief executive in September 2026 as the company continues its commercial scale-up.
  • FY27 guidance targets revenue of US$113 million to US$122 million, alongside continued adjusted EBITDA losses.

Saluda Medical, Inc. (ASX:SLD) enters September 2026 with a clear operating tension: commercial adoption is expanding, but the Business is still consuming substantial cash. FY26 revenue reached US$90.2 million, the company broadened its product offering with a new paddle lead, and a chief executive transition was announced in September. The near-term Investment case therefore rests less on headline growth and more on whether Saluda can convert a larger commercial footprint into better Operating Leverage during FY27.

Company Overview

Saluda Medical, Inc. (ASX:SLD) develops closed-loop spinal cord stimulation technology for chronic pain. Its Evoke system measures neural responses to stimulation and adjusts therapy in real time, with commercial activity concentrated in the United States and selected international markets.

During 2026, the company expanded its commercial platform through FDA approval for its CAP24 surgical paddle lead and the global rollout of EVA automated programming. Saluda has positioned these additions as tools to broaden physician access and reduce programming burden across its neuromodulation offering.

On 7 September 2026, Saluda Medical (ASX:SLD) announced that Barry Regan would depart as chief executive and that Mike Mathias would assume the role. The Leadership change comes while the company is still scaling sales coverage and introducing new products.

Financial and Operational Position

FY26 revenue was US$90.2 million. United States revenue contributed US$63.2 million and international revenue contributed US$26.9 million. Gross margin was 48.9%, while adjusted EBITDA remained negative at US$113.7 million.

Operating cash use for FY26 was US$116.0 million. Saluda reported 2,676 United States patient implants for the year, including 769 in the June quarter. Average quarterly active implanting physicians were 286, while the United States sales force stood at 161 representatives at year end.

For FY27, management guided to revenue of US$113 million to US$122 million, gross margin of 50% to 52%, and adjusted EBITDA of negative US$101 million to negative US$95 million. The guidance implies continued investment before the business reaches profitability.

What Investors May Watch Next

Paddle lead commercialisation is a key operational checkpoint, particularly the pace of surgeon adoption and the productivity of the expanded commercial team. Investors may also monitor whether gross margin moves toward the FY27 target range while revenue scales.

The chief executive transition adds another execution variable. Clear operating priorities, disciplined cash deployment and progress toward narrowing adjusted EBITDA losses will be important measures through the next reporting periods.

Risks

Saluda remains loss-making and cash intensive, which keeps funding capacity central to the outlook. Commercial adoption can also be affected by reimbursement decisions, physician uptake, product Training and competition from much larger medical-device groups.

FY27 guidance remains a forecast rather than an achieved result. A leadership transition during a rapid commercial expansion creates additional execution risk, particularly if sales productivity or product uptake develops more slowly than planned.

Key Insights

Saluda Medical (ASX:SLD) has reached meaningful commercial scale, but the financial model is still defined by substantial operating investment. FY27 will test whether higher revenue, a broader product portfolio and improved gross margin can begin to narrow the gap between commercial momentum and cash consumption.