Key points
- FY26 revenue: $90.2M, 28% growth vs FY25
- Gross margin: 48.9%, 230 bps above FY25
- FDA approval for CAP24 paddle lead
- FY27 revenue guidance: 25%-35% growth
- FY27 gross margin: 50%-52%
Full summary
Saluda Medical, Inc. reported its FY26 full-year results, showcasing a 28% increase in revenue to $90.2 million. The company achieved a gross margin of 48.9%, 230 basis points above FY25 and ahead of IPO prospectus estimates. Saluda also received FDA approval for its CAP24 paddle lead, expanding its Evoke System portfolio. The company's US commercial momentum continued to build with a 27% increase in US revenue and 34% growth in US implanted patients. International revenue grew by 32%, driven by demand in Europe and Australia. Saluda's FY27 guidance includes revenue growth of 25%-35% and gross margin of 50%-52%. The company expects adjusted EBITDA loss to be between $101 million and $95 million, reflecting improved operating leverage.
Guidance
FY27 revenue growth: 25%-35%, gross margin: 50%-52%, adjusted EBITDA loss: $101M-$95M
Outlook
Saluda expects FY27 revenue growth driven by expanding physician base, international demand, and new product launches. The company anticipates gross margin expansion and improved adjusted EBITDA performance due to operating leverage.