Saluda Medical Launches CAP24 Surgical Paddle Lead Across the US
Saluda Medical (ASX: SLD) announced the full US commercial release of the CAP24™ Surgical Paddle Lead on 5 October 2026, following FDA approval earlier this year. The device extends the company’s closed-loop spinal cord stimulation platform into the surgical paddle lead format.
The release follows the completion of a successful limited market release in selected centers. During that period, physicians provided positive feedback on the device’s performance and its integration into clinical practice.
CAP24 is now being made broadly available to neurosurgery and orthopaedic spine practices across the US. The company describes it as “the first and only FDA-approved surgical paddle lead purpose-built for physiologic, dose-controlled closed-loop therapy.”
Key facts at a glance
- Product: CAP24™ Surgical Paddle Lead, designed to deliver Evoke® Therapy
- Status: full US commercial release after FDA approval and a limited market release
- Channel: neurosurgery and orthopaedic spine practices across the US
- Segment: approximately 30% of US spinal cord stimulation (SCS) implants
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Opening up the surgical segment, about 30% of US SCS implants
According to Mike Mathias, Chief Executive Officer of Saluda Medical, Evoke Therapy has until recently only been available through percutaneous leads. CAP24 now extends the therapy to patients who require a paddle lead.
For investors, the relevant detail is market reach. The surgical segment represents approximately 30% of US SCS implants, and the release expands access to it. The announcement does not quantify any revenue or market size figures.
On design, the company states that CAP24 has a low-profile, anatomically contoured profile that supports stable placement and broad coverage. It enables the Evoke® System to measure each patient’s unique neural response and adapt stimulation with every pulse.
Mike Mathias, Chief Executive Officer, Saluda Medical
“…This marks an important step towards making physiologic, dose-controlled closed-loop therapy available to all appropriate patients.”
Physician perspective
Erika Petersen, MD, Professor of Neurosurgery at the University of Arkansas for Medical Sciences, commented on the real-time feedback the device provides.
Erika Petersen, MD, Professor of Neurosurgery, University of Arkansas for Medical Sciences
“…By providing real-time physiologic feedback, it allows stimulation to be adjusted as neural responses change, helping maintain consistent therapy delivery and a more predictable treatment experience.”
Closed-loop SCS explained: why dose control matters
Spinal cord stimulation (SCS) is a therapy used to manage chronic pain. The Evoke System is designed to treat chronic neuropathic pain by providing SCS therapy that senses and measures neural activation.
Saluda describes its platform as closed-loop, meaning it automatically adjusts therapy based on real-time neurophysiological feedback. The company contrasts this with open-loop therapy, and CAP24 now brings this approach to the surgical paddle lead format.
In simple terms, the process works in three steps:
- Sense: the system detects the patient’s neural response to stimulation.
- Measure: the response is measured, and it is unique to each patient.
- Adjust: stimulation is adapted with every pulse.
Clinical evidence behind Evoke Therapy
CAP24 is designed to deliver Evoke Therapy, which has demonstrated durable clinical outcomes in the EVOKE study. More than 90% of patients who responded at three months remained responders at 36 months.
The company describes EVOKE as the first and only prospective, multicenter, parallel-arm, double blind, randomized controlled pivotal study with a voluntary crossover arm in SCS. Results have been published across three journals.
| Timepoint | Journal |
|---|---|
| 12 months | The Lancet Neurology |
| 24 months | JAMA Neurology |
| 36 months | Regional Anesthesia and Pain Medicine |
The EVOKE data relate to Evoke Therapy. The announcement does not present separate trial data for CAP24 itself.
What to watch next
The announcement does not disclose revenue expectations, pricing or rollout milestones. It also contains no sales targets or financial guidance.
Saluda’s FY26 revenue results of US$90.2M, up 28% year-on-year, give context for the commercial base on which the surgical paddle opportunity is being built, alongside FY27 guidance of US$113-122M.
Points to watch include the pace of adoption among neurosurgery and orthopaedic spine practices and any further commentary from management. The stated aim from Mathias is to make physiologic, dose-controlled closed-loop therapy available to all appropriate patients.
Mathias’ appointment as CEO, effective 7 September 2026, places the former Chief Commercial Officer in charge of the CAP24 commercialisation agenda he helped shape.
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