Key Highlights

  • Saluda began the full US commercial release of the CAP24 Surgical Paddle Lead, following FDA approval earlier in 2026 and a limited market release in selected centres.
  • CAP24 is described as the first and only FDA-approved surgical paddle lead built for dose-controlled closed-loop therapy with the Evoke System.
  • The surgical segment represents roughly 30% of US spinal cord stimulation implants, and the release gives no sales, order or Revenue figures for CAP24.

Saluda Medical, Inc. (ASX:SLD), a commercial-stage medical device company developing closed-loop neuromodulation treatments for chronic neurological conditions, announced on 5 October 2026 the full US commercial release of its CAP24 Surgical Paddle Lead. The release follows FDA approval earlier in 2026.

From limited release to broad availability

CAP24 is now being made broadly available to neurosurgery and orthopaedic spine practices across the United States, after a limited market release in selected centres. The company says physicians gave positive feedback during that limited release on the device's performance and its integration into clinical practice. The announcement does not state the number of centres involved in the limited release or any implant volumes.

What CAP24 is designed to do

Saluda describes CAP24 as the first and only FDA-approved surgical paddle lead purpose-built for physiologic, dose-controlled closed-loop therapy. It enables the Evoke System to measure each patient's neural response and adapt stimulation with every pulse. The company says its low-profile, anatomically contoured design supports stable Placement and broad coverage. Until now, the release states, Evoke Therapy has only been available through percutaneous leads, so the paddle lead extends it to patients who require a surgical lead.

Size of the surgical segment

The company says the surgical paddle segment represents approximately 30% of US spinal cord stimulation (SCS) implants. CAP24 therefore addresses a segment that Saluda's existing leads did not serve. The release frames the launch as a step towards making physiologic, dose-controlled closed-loop therapy available to all appropriate patients, but it does not forecast adoption or market share.

Clinical evidence cited

The release cites the EVOKE study, which it describes as the first and only prospective, multi-centre, parallel-arm, double-blind, randomised controlled pivotal study with a voluntary crossover arm in SCS. Twelve-month results were published in The Lancet Neurology, 24-month results in JAMA Neurology and 36-month data in Regional Anesthesia and Pain Medicine. The company says that more than 90% of patients who responded at three months remained responders at 36 months.

The Evoke System is indicated as an aid in managing chronic intractable pain of the trunk and limbs, including failed back surgery syndrome, intractable low back pain and leg pain. Saluda directs readers to its website for risks and important safety information, and notes that its CHESS Depositary Interests are subject to foreign ownership restrictions under US securities law.

Platform description

Saluda describes its closed-loop, dose-control platform as one that senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback. The Evoke System is its first product, designed to treat chronic neuropathic pain by providing SCS therapy that senses neural activation to optimise therapy and reduce patient and clinician burden. The company's focus extends to other chronic neurological conditions, though no other indication is described in this release.

What the release does not state

The release does not give the date of FDA approval beyond "earlier this year", the number of centres in the limited market release, pricing, implant targets or revenue expectations. It was authorised by Saluda's Disclosure Committee, and the company directs readers to its website for risk and safety information on the Evoke System.