Saluda opens the surgical channel with first U.S. CAP24 paddle lead cases
Saluda Medical (ASX:SLD) has completed the first U.S. surgical cases using its newly FDA-approved Evoke CAP24 paddle lead. The procedures mark the first time Evoke physiologic closed-loop therapy has been delivered in surgical paddle lead procedures in the U.S.
Saluda is a commercial-stage medical device company focused on treating chronic neurological conditions through its closed-loop neuromodulation platform. The milestone opens a new surgical segment for its Evoke Therapy.
The first procedure was performed by Dr. Erika A. Petersen, Professor of Neurosurgery at the University of Arkansas for Medical Sciences (UAMS), on July 10. A second followed on July 14, carried out by Dr. Steven M. Falowski, Director of Functional Neurosurgery at the Advanced Surgery Center of Lancaster in Pennsylvania.
When big ASX news breaks, our subscribers know first
A new market segment: what CAP24 unlocks
The debut of CAP24 extends closed-loop therapy into the surgical paddle lead channel for the first time, a segment previously outside Evoke’s reach. The commercial relevance is straightforward: paddle leads account for a meaningful share of the U.S. spinal cord stimulation market.
The FDA cleared the CAP24 paddle lead on 30 June 2026, making it the first SCS paddle lead purpose-built for closed-loop neuromodulation with a 24-electrode, three-column configuration engineered specifically for ECAP-based therapy rather than adapted from an open-loop design.
Key points from the update include:
-
CAP24 is the first SCS paddle lead engineered specifically for closed-loop neuromodulation
-
Paddle leads represent roughly 30% of U.S. SCS implants
-
Paddle leads are preferred by many neurosurgeons and orthopedic spine surgeons
That 30% figure frames a materially new addressable segment for Evoke Therapy, broadening the platform’s reach into cases historically served by conventional stimulation.
Mike Mathias, Chief Commercial Officer of Saluda Medical
“These first U.S. surgical cases are an important milestone for Saluda and for patients. CAP24 opens the surgical channel for closed-loop therapy and brings Evoke Therapy to more people who need it.”
Understanding closed-loop neuromodulation
Spinal cord stimulation (SCS) is a therapy used to treat chronic neuropathic pain, which is long-term nerve-related pain often affecting the back and limbs. Conventional systems deliver fixed, or open-loop, stimulation that does not respond to changes in a patient’s neural activity.
Saluda’s closed-loop system works differently. It senses and measures each patient’s neural signals and automatically adjusts therapy in real time based on that feedback. Dr. Petersen described this approach as delivering “physiologic, ECAP-based neuromodulation” into paddle procedures.
For investors, the technology differentiation forms the foundation of Saluda’s competitive positioning. Delivering objective, real-time therapy backed by published clinical evidence separates the Evoke System from fixed-output alternatives.
What surgeons are saying
Physician commentary reinforced the clinical significance of bringing closed-loop therapy into surgical paddle procedures.
Dr. Erika A. Petersen
“Bringing Evoke’s physiologic, ECAP-based neuromodulation into paddle procedures gives patients more consistent, objective therapy.”
Dr. Steven M. Falowski
“CAP24 brings Evoke’s real-time, physiology-based approach into the operating room, which is an important evolution for SCS.”
Clinical evidence underpinning the investment case
The Evoke System is supported by prospective, randomized evidence demonstrating durable outcomes through 36 months. The EVOKE study is described as the first and only prospective, multi-centre, parallel-arm, double-blind, randomized controlled pivotal study with a voluntary crossover arm in SCS.
The published, peer-reviewed data spans three timepoints across leading medical journals.
| Timepoint | Study Finding | Publication |
|---|---|---|
| 12 months | Clinically superior pain relief versus open-loop therapy | The Lancet Neurology |
| 24 months | Continued outcomes reported | JAMA Neurology |
| 36 months | Sustained, durable pain relief | Regional Anesthesia and Pain Medicine |
For investors, the durable 36-month evidence base supports the case for long-term clinical adoption.
The next major ASX story will hit our subscribers first
What comes next
The introduction of CAP24 opens access to the surgical and paddle segment previously outside Evoke’s reach, extending the commercial channel available to Saluda’s closed-loop platform. No specific rollout timeline or financial guidance was disclosed alongside the surgical cases.
The Perceptive credit facility drawdown, completed on the same day as the FDA approval, brought total debt drawn to US$100m of a US$125m facility, with a further US$25m tranche available through December 2026 to fund the commercial scaling that the CAP24 launch now demands.
The announcement was authorised for release by Saluda Medical’s Disclosure Committee.
With the first U.S. surgical cases now completed, Saluda continues to broaden the reach of closed-loop therapy across a wider range of patients and procedures.
Don’t Miss the Next Healthcare Breakthrough on ASX
Big News Blast delivers FREE breaking ASX healthcare news directly to your inbox within minutes of release, complete with in-depth analysis. Join 20,000+ subscribers already staying ahead of the market. Click the “Free Alerts” button at StockWire X to start receiving alerts the moment market-moving announcements hit.