Highlights

  • Saluda Medical moved its CAP24 surgical paddle lead to full commercial release in the United States in October 2026.
  • CAP24 is designed for use with the Evoke System and is intended for neurosurgery and orthopaedic spine practices.
  • The company says the device supports physiologic, dose-controlled closed-loop spinal cord stimulation by enabling measurement of neural responses.
  • The announcement did not provide CAP24 sales targets, pricing, reimbursement assumptions or expected Revenue contribution.

Saluda Medical (ASX:SLD) develops the Evoke spinal cord stimulation system for the management of chronic intractable pain. On 6 October 2026, the company reported that its CAP24 surgical paddle lead had moved to full commercial release in the United States after a limited market release, widening availability of the device to neurosurgery and orthopaedic spine practices.

CAP24 Moves to Full US Commercial Release

The company said the commercial release was dated 5 October 2026. CAP24 is a surgical paddle lead designed for use with the Evoke System. Saluda described the device as low-profile and anatomically contoured, with the design intended to support stable Placement and broad stimulation coverage. The announcement stated that CAP24 received US Food and Drug Administration approval earlier in 2026, although it did not provide the exact approval date.

The full release follows a limited market release in selected centres. Saluda said that phase generated positive physician feedback and provided the basis for wider commercial availability across the United States.

How CAP24 Fits the Evoke System

According to Saluda, CAP24 is purpose-built for physiologic, dose-controlled closed-loop therapy. When used with the Evoke System, the lead enables the system to measure neural responses and adjust stimulation with each pulse. The company positions this feedback-based approach as a core feature of its closed-loop spinal cord stimulation technology.

The Evoke System is indicated for management of chronic intractable pain of the trunk and limbs, including certain forms of low back and leg pain. The company said CAP24 expands access to this therapy for patients who require a surgical paddle lead rather than another lead configuration.

Commercial Access Broadens in the United States

Saluda said the surgical segment accounts for about 30 per cent of spinal cord stimulation implants in the United States. The full release therefore extends the company's addressable clinical setting to practices that use paddle leads in neurosurgical and orthopaedic spine procedures.

The announcement did not state how many centres are currently using CAP24 or how quickly the company expects adoption to develop. It also did not provide sales targets, pricing information, reimbursement assumptions, Manufacturing volumes or a forecast revenue contribution from the product.

Clinical Evidence Referenced by the Company

Saluda also referred to 36-month results from its EVOKE study, reporting that more than 90 per cent of patients who had responded at three months remained responders at 36 months. The announcement presented this as evidence of sustained pain relief from the Evoke closed-loop approach. It did not state that the result related specifically to the CAP24 paddle lead, so the figure applies to the broader Evoke therapy evidence described by the company.

Key Insights

CAP24 has progressed from limited release to full US commercial availability, giving Saluda a paddle-lead option within the Evoke platform for neurosurgery and orthopaedic spine practices. The development expands product access, but the announcement does not quantify the commercial impact. Future company updates will be needed to show adoption levels, centre expansion and any measurable contribution from CAP24 to revenue or procedure volumes.