Saluda Medical Posts 28% Revenue Growth in FY26 and Eyes $113M+ in FY27

Saluda Medical caps FY26 with 28% revenue growth and upgraded market ambitions

In its FY26 results presentation released on 28 August 2026, Saluda Medical outlined a year of accelerating commercial momentum, reporting global revenue of US$90.2M, up 28% year-on-year. That result exceeded the company’s upgraded guidance of US$87.0M and sat well above the IPO prospectus forecast of US$81.8M.

Management detailed that the US business exited FY26 growing at +45% in Q4, while global Q4 revenue rose +43% versus the prior comparative period (PCP). The presentation highlighted that all headline metrics, including revenue, gross margin, adjusted EBITDA and operating cash use, came in ahead of the IPO prospectus.

Investors should note that the FY26 financials are presented on a preliminary and unaudited basis. Figures are reported in US dollars.

FY26 results and FY27 guidance at a glance

The presentation detailed a financial scorecard showing improvement across every key line item for the completed year. Revenue growth was broad-based, with US revenue up 27% and international revenue up 32% year-on-year.

Gross margin expanded 230 basis points year-on-year to 48.9%, which management noted was 300 basis points ahead of prospectus. Adjusted EBITDA and cash used in operations both tracked ahead of prospectus expectations.

FY27 guidance signals continued acceleration

Management provided forward guidance pointing to continued growth in FY27:

• FY27 revenue guidance: US$113–122M (+25% to +35% Y/Y)

• FY27 gross margin: 50%–52%

• FY27 adjusted EBITDA: ($101M) – ($95M), an improvement of $13M to $19M

• Approximately 90% of incremental USD gross profit is expected to convert to adjusted EBITDA improvement, reflecting operating leverage

The presentation attributed expected FY27 growth to more active physicians, higher utilisation, and the CAP24™ paddle lead launch.

What is spinal cord stimulation — and how Evoke® is different

Spinal cord stimulation (SCS) is a therapy for chronic pain that uses an implanted device to deliver small electrical pulses to the spinal cord. The presentation framed SCS as an established yet significantly underserved market. Key market context included:

• Approximately 24% of American adults have chronic pain

• Around US$2.67B in worldwide SCS device revenue was generated in 2024

• A US Total Addressable Market of approximately US$23B, with estimated penetration of only around 6%

• Well-established reimbursement, including codes, coverage and payment

The closed-loop advantage

Saluda’s Evoke® system is designed around a closed-loop approach. It stimulates the spinal cord, then uses the same lead to sense and measure the resulting neural response, known as an ECAP (evoked compound action potential). The system compares that measurement against a target and adjusts therapy on every pulse to maintain a personalised “neural dose”.

This differs from conventional systems, which rely largely on subjective patient feedback. According to the presentation, this durability underpins the clinical results reported from the EVOKE 36-month study:

• 83% responder rate at 36 months

• 90% durability of response

• Zero efficacy-loss explants in the EVOKE clinical trial

Commercial momentum — Q4 FY26 the strongest quarter yet

Drawing on the Q4 FY26 Quarterly Activity Report within the presentation, management detailed accelerating global revenue growth and continued commercial momentum in Q4 FY26. Total revenue reached US$27.0M, up 43% on the prior comparative period, with US patients implanted rising 50% year-on-year.

The presentation noted that international revenue in Q4 included approximately US$0.6M from timing changes in revenue recognition following the launch of EVA in Europe.

Additional momentum points detailed in the update include:

• US patients implanted rose 50% in Q4 as the sales team expanded

• Active implanting physicians remain only around 4% penetrated of the approximately 7,800 US SCS physician universe

• The company is beginning to gain share in the high-volume ambulatory surgery centre (ASC) channel

The growth runway — paddle lead, sales force leverage and margin expansion

The presentation outlined several strategic levers management expects to drive growth into FY27 and beyond, spanning a new product segment, sales force productivity, and margin expansion.

Paddle lead opens a ~$670M new market

The ortho/neurosurgeon paddle lead (CAP24™) received FDA approval and has been selling since July 2026, with a limited commercial launch underway and a move to full US commercial launch anticipated later in calendar 2026.

The CAP24 FDA approval, granted on 30 June 2026, marked Saluda’s first access to the surgeon-preferred segment of the SCS market, with the 24-electrode, three-column paddle purpose-built for closed-loop neuromodulation rather than adapted from an open-loop design.

Management stated that this De Novo Paddle opens an estimated US$670M annual market, representing around 30% of US SCS implants and a surgeon call point Saluda does not reach with percutaneous leads. The presentation described the paddle as carrying a higher ASP and being gross margin accretive.

Sales force built — focus shifts to productivity

The presentation detailed the scaling of Saluda’s US commercial infrastructure and a shift in focus toward productivity:

• Approximately 60% of the US sales force was fully trained entering FY27; average fully trained reps rose 62% Y/Y (FY26: 89 vs FY25: 55)

• US territory coverage increased from around 26% in FY25 to approximately 45% in FY26

• Saluda reps are estimated to be around 60% more productive than traditional industry reps, aided by low reprogramming burden and EVA automation

• Future sales force growth is expected to slow, with the FY27 focus on productivity and lower selling costs

A clear path to higher margins

Management outlined a gross margin pathway rising from 45% in FY24 to 49% in FY26, with FY27 guidance of 50%–52% and a long-term target in the mid-60s%. Around 70% of cost of goods sold relates to the implantable pulse generator (IPG) and leads.

The presentation noted that a next-generation IPG with a smaller form factor and next-generation percutaneous leads, both targeted for calendar 2027, are designed to address these largest cost drivers. Supporting drivers include supply chain reconfiguration, competitive sourcing, volume price breaks, and a favourable US mix shift.

Why Saluda stands apart

The presentation closed by framing Saluda’s positioning around two structural problems the SCS industry has long faced: the durability of clinical outcomes and the cost of managing the therapy. The company positioned its closed-loop technology and EVA automation as addressing both.

Presentation positioning statement

“Saluda not only growing within SCS – we are solving the structural challenges that have limited the industry growth.”

The closing runway summary highlighted:

• +43% Q4 FY26 revenue growth

• Only ~4% US physician penetration

• ~$670M paddle addition to addressable market

• <1 programming visit per patient per year after the first 12 months

With the CAP24™ paddle launch progressing toward full US rollout, a substantially expanded sales force shifting toward productivity, and a defined pathway to higher margins, management pointed to significant runway remaining across the growth drivers outlined for FY27.

Saluda drew the second tranche of its Perceptive credit facility on 30 June 2026, bringing total drawdowns to US$100M of a US$125M facility, with a further US$25M remaining available through December 2026 to fund the commercial scaling the CAP24 launch and sales force expansion now demand.

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