SLD Receives FDA Approval for CAP24 Surgical Paddle Lead

• FDA approval for CAP24 surgical paddle lead
• Expands addressable market by targeting neurosurgeons
• Phased U.S. launch starting in the second half of 2026
• Enhances existing U.S. commercial organization

Saluda Medical, a commercial-stage medical device company, announced that the U.S. Food and Drug Administration (FDA) has approved its CAP24 surgical paddle lead. This approval allows the lead to be marketed and sold in the U.S., targeting neurosurgeons and orthopedic surgeons, who prefer surgical implantation of a paddle lead for spinal cord stimulation (SCS) procedures. The CAP24 paddle lead is the first and only SCS paddle engineered for closed-loop neuromodulation, enhancing productivity within Saluda's U.S. commercial organization. The company plans a phased U.S. launch starting in the second half of 2026, with broader commercial rollout later in the year.