Saluda Medical Beats FY26 Revenue Guidance with 28% Growth and FDA Approval

Robust Revenue Growth Exceeds Guidance

Saluda Medical (ASX:SLD) closed FY26 with a full-year revenue haul of US$90.2 million, comfortably surpassing its upgraded guidance of US$87.0 million and marking a 28% increase on the prior year. The final quarter alone delivered US$27.0 million, a 43% uplift compared to the same period last year, fuelled by a 45% surge in US sales and a 39% rise internationally.

FDA Approval Unlocks New Surgical Channel

The company’s recent FDA approval of the CAP24 paddle lead represents a strategic breakthrough, broadening the Evoke® System’s footprint into surgical paddle lead procedures. This device targets neurosurgeons and orthopaedic spine surgeons, a segment accounting for roughly 30% of US spinal cord stimulation (SCS) implants and previously untapped by Saluda due to product limitations. Initial US surgical cases using the CAP24 paddle lead were performed in July, signalling the start of a phased launch slated for the second half of 2026. The addressable market here is estimated at US$670 million, offering a meaningful new revenue avenue as surgeon training and inventory scale up. This expansion follows the company's earlier regulatory wins, including CE certification for its EVA™ Sensing Technology across Europe and Australia.

US Commercial Momentum Driven by Sales Force and Physician Growth

US sales momentum remains the engine room of growth. Q4 implanted patients rose 50% year-on-year to 769, supported by a 22% increase in active implanting physicians and a 23% boost in physician utilisation. The company’s US sales force exceeded expectations, ending FY26 with 161 representatives, well above the forecasted 154, and averaging 89 fully trained reps during the year. This expanded footprint, combined with targeted physician education and broader adoption in high-volume Ambulatory Surgical Centre accounts, continues to drive penetration and utilisation.

International Expansion and EVA™ Technology Rollout

International revenues climbed 39% in Q4 to US$8.5 million, with strong demand in Europe and Australia. A notable driver was the EVA automated programming technology, which was fully launched internationally during the year. EVA simplifies therapy programming and optimises clinical workflows, enhancing physician productivity and patient outcomes. This technology rollout aligns with Saluda’s strategy to standardise treatment experience across geographies and supports ongoing physician training and market development efforts, including a high-profile presence at the American Society of Pain and Neuroscience conference in Miami.

Cash Flow and Operational Efficiency

Saluda ended Q4 with US$116.4 million in cash, down slightly from US$121.0 million the previous quarter, after drawing US$24.6 million net from its debt facility to support ongoing investments. Operating cash outflows of US$28.9 million in Q4 were consistent with the prior quarter, reflecting continued investment in the US sales force and product development. The company executed a phased reduction of around 50 non-commercial roles to manage operating expenses, contributing to a full-year cash used in operations of US$118.2 million; an improvement on IPO prospectus estimates. Total available funding stood at US$141.4 million, providing a runway of approximately five quarters at current burn rates.