Highlights
- Global revenue rose 26% to US$23.1 million in Q1 FY27.
- US revenue increased 34% to US$17.4 million, with US patient implants up 55% to 838.
- FY27 revenue guidance of US$113 million to US$122 million was reaffirmed.
- Mike Mathias was appointed CEO.
Saluda Medical, Inc. (ASX:SLD) has released its Q1 FY27 update, reporting strong revenue growth led by its US business. The medical device company, which develops spinal cord stimulation technology for chronic pain, also reaffirmed its FY27 guidance and provided updates on its product pipeline.
Q1 FY27 Financial Performance
Global revenue for the quarter was US$23.1 million, up 26% on the prior corresponding period. US revenue rose 34% to US$17.4 million, while international revenue increased 7% to US$5.8 million, driven mainly by Australia and Germany.
US patient implants increased 55% to 838, and the average number of quarterly active implanting physicians in the US rose 47% to 374. The figures are unaudited, and some are described as preliminary.
Product Pipeline Progress
Full US commercial release of CAP24 is underway. Saluda's paddle lead has received FDA approval, with a limited launch in July 2026 and full US commercial launch planned later in Q2 FY27. The company estimates the paddle lead opens about US$670 million of the US spinal cord stimulation market that it does not currently address, mainly among orthopaedic and neurosurgeon customers.
The EVA automated programming feature has been launched, and a smaller form-factor implantable pulse generator is due to be submitted. Saluda highlighted company-reported data from its EVOKE study, including an 83% responder rate at 36 months.
FY27 Guidance and Leadership
Saluda reaffirmed its FY27 guidance, which includes revenue of US$113 million to US$122 million, representing growth of 25% to 35%. Gross margin is expected at 50% to 52%, and adjusted EBITDA is expected to be a loss of US$95 million to US$101 million.
Mike Mathias, previously Chief Commercial Officer, has been appointed CEO. The company will continue expanding its sales force into new territories and channels, including ambulatory surgical centres.
Key Takeaways
- Saluda delivered 26% revenue growth in Q1 FY27, led by the US market.
- US implants and active physicians increased strongly year on year.
- The paddle lead launch could expand Saluda's addressable US market.
- FY27 guidance has been reaffirmed.






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