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Saluda Medical, Inc. (ASX:SLD)

ALERT: Price-sensitive ASX Announcement for SLD
Current share price for SLD : $0.515 0.105 (25.61%)+
Announcement
Release
30 Jun 2026 9:29AM
Price at Release
$0.410
Full Release
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Summary
Saluda Medical, Inc. has received FDA approval for its new CAP24 surgical paddle lead, allowing it to be marketed and sold in the U.S. This new product is the first SCS paddle lead designed specifically to deliver closed-loop neuromodulation using Saluda's Evoke System with EVA Sensing Technology. The CAP24 paddle lead is aimed at expanding the company's market reach by appealing to neurosurgeons and orthopedic surgeons who prefer surgical implantation of paddle leads for spinal cord stimulation (SCS). Saluda plans a phased U.S. launch starting in the latter half of 2026, with expectations of gradually increasing revenue as the surgical channel matures. The design of CAP24, featuring a 24-electrode, three-column configuration, allows it to adapt stimulation to each patient's physiology based on real-time neurophysiological feedback.
Key Points
  • Saluda Medical receives FDA approval for CAP24 paddle lead.
  • CAP24 is designed for closed-loop neuromodulation.
  • Phased U.S. launch planned for second half of 2026.
  • CAP24 targets neurosurgeons and orthopedic surgeons.
  • FDA approval expands Saluda's U.S. market reach.
  • Features a 24-electrode, three-column configuration.
  • Real-time feedback to adapt stimulation to patients.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.