Saluda Medical Achieves U.S. Milestone with First Surgeries Using FDA-Cleared CAP24™ Paddle Lead for Closed-Loop Spinal Cord Stimulation

Saluda Medical Marks Commercial Breakthrough with First U.S. CAP24™ Paddle Lead Surgeries

In its July 16, 2026 update, Saluda Medical confirmed the successful completion of the first two U.S. surgical procedures using the Evoke® CAP24™ paddle lead at distinct institutions within days. The initial surgery was performed by Dr. Erika A. Petersen, Professor of Neurosurgery at the University of Arkansas for Medical Sciences (UAMS), on July 10, 2026. The second procedure occurred on July 14, 2026, conducted by Dr. Steven M. Falowski, Director of Functional Neurosurgery at the Advanced Surgery Center of Lancaster in Pennsylvania.

These cases represent the inaugural use of Evoke physiologic closed-loop therapy delivered through a surgical paddle lead in the U.S. Before FDA clearance and the commercial launch of CAP24, the Evoke System was only available with percutaneous lead options. This milestone opens the surgical channel—previously inaccessible for closed-loop therapy—to Evoke. Mike Mathias, Chief Commercial Officer, described this achievement as "an important milestone for Saluda and for patients," emphasizing that CAP24 "opens the surgical channel for closed-loop therapy and extends Evoke Therapy to more patients in need."

Understanding the CAP24™ Paddle Lead and Its Advantages Over Traditional Spinal Cord Stimulation Devices

Saluda Medical presents the CAP24™ as the first spinal cord stimulation paddle lead engineered specifically for closed-loop neuromodulation. Conventional paddle leads deliver open-loop stimulation—a fixed, preset output that does not adjust in real time to neural signals. In contrast, CAP24 incorporates sensing technology that measures patients’ evoked compound action potentials (ECAPs), capturing real-time neural responses to stimulation and automatically modulating therapy accordingly.

This innovation is central to Saluda Medical's commercial strategy. The Evoke System, now including CAP24 for surgical paddle lead implants, operates on a closed-loop, dose-control platform that continuously senses and adjusts therapy based on neurophysiological feedback without manual reprogramming by clinicians or patients. This approach aims to optimize treatment efficacy while reducing burdens on both patients and healthcare providers. CAP24 extends these benefits to surgical paddle lead procedures for the first time in the U.S.

Significance of Paddle Leads Accounting for 30% of U.S. Spinal Cord Stimulation Implants

A key commercial insight from Saluda Medical’s update is that paddle leads constitute approximately 30% of spinal cord stimulation implants in the U.S. This statistic highlights the importance of CAP24’s FDA approval and initial use, as it enables Saluda to address a previously untapped segment of patients and surgeons who prefer or require surgical paddle lead implantation rather than percutaneous leads.

Paddle leads are favored by many neurosurgeons and orthopedic spine surgeons due to clinical and anatomical advantages, such as broader electrode coverage and enhanced positional stability in select patients. By entering this procedural segment, Saluda Medical targets a substantial portion of the spinal cord stimulation market that was inaccessible with its prior closed-loop platform. Although the company has not disclosed revenue forecasts, implant volume targets, or market share goals, the strategic rationale of accessing roughly 30% of the U.S. SCS implant market is clearly emphasized.

Profiles of Surgeons Performing the First U.S. CAP24 Cases and Their Institutional Settings

The surgeons involved in the first U.S. CAP24 procedures provide insight into the early clinical adoption landscape. Dr. Erika A. Petersen, Professor of Neurosurgery at UAMS—a leading academic medical center—performed the initial case on July 10, 2026. Her participation aligns with the trend of academic centers pioneering novel neuromodulation technologies. Dr. Petersen noted that "bringing Evoke's physiologic, ECAP-based neuromodulation into paddle procedures offers patients more consistent, objective therapy."

Dr. Steven M. Falowski, Director of Functional Neurosurgery at the Advanced Surgery Center of Lancaster—a non-academic ambulatory surgical facility—conducted the second procedure on July 14, 2026. His involvement indicates that CAP24’s early commercial reach extends beyond academic hospitals into specialized community surgical centers. Dr. Falowski described CAP24 as introducing "Evoke's real-time, physiology-based approach into the operating room," calling it "an important evolution for spinal cord stimulation." The near-simultaneous surgeries at geographically and institutionally diverse sites may reflect a coordinated early commercial launch, although the company did not detail rollout plans.

Robust Clinical Evidence Supporting the Evoke System Published in Leading Medical Journals

Saluda Medical reiterates the strong clinical foundation for the Evoke System, which encompasses CAP24. The system is supported by the EVOKE study—the first and only prospective, multi-center, parallel-arm, double-blind, randomized controlled pivotal trial with a voluntary crossover arm in spinal cord stimulation. This rigorous study design is rare in medical device research compared to pharmaceuticals.

Key results from the EVOKE study have been published in several peer-reviewed journals: 12-month outcomes demonstrating superior pain relief over open-loop therapy appeared in The Lancet Neurology; 24-month data were published in JAMA Neurology; and the 36-month follow-up showing sustained pain relief was featured in Regional Anesthesia and Pain Medicine. Saluda emphasizes that the Evoke System is "supported by prospective, randomized evidence demonstrating durable outcomes through 36 months," and that CAP24 inherits this evidence base for paddle lead procedures.

Approved Indications and Target Patient Population for the Evoke System and CAP24

The regulatory indications for the Evoke System—and by extension CAP24—define the patient population Saluda Medical aims to serve. The system is approved as an aid in managing chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain related to failed back surgery syndrome, intractable low back pain, and leg pain.

Designed to treat chronic neuropathic pain, the system delivers spinal cord stimulation that senses and measures neural activation to optimize therapy and reduce burdens on patients and clinicians. Chronic intractable back and lower limb pain, including failed back surgery syndrome, pose significant challenges worldwide, including in the U.S. Spinal cord stimulation is an established treatment for patients unresponsive to other therapies, and Saluda’s Evoke platform offers a differentiated closed-loop approach within this category.

Closed-Loop Versus Open-Loop Spinal Cord Stimulation: Saluda Medical’s Technological Edge

The core technological difference between Saluda Medical’s platform and traditional spinal cord stimulation systems lies in the closed-loop mechanism. Open-loop systems deliver fixed, pre-programmed electrical stimulation without real-time sensing or adjustment based on the patient’s neural response. While clinicians and patients may periodically modify settings, these systems do not self-adjust dynamically.

Conversely, Saluda’s platform continuously measures evoked compound action potentials (ECAPs)—electrical signals generated in nerve fibers in response to stimulation—and automatically adjusts therapy delivery. This ensures stimulation remains within a therapeutic window that accounts for physiological variations due to posture, movement, and neural responsiveness throughout daily activities. The company describes its technology as a "closed-loop, dose-control platform" that "senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback." The CAP24 paddle lead brings this capability into the surgical implant setting, where paddle leads are positioned directly on spinal cord anatomy and may provide distinct sensing advantages compared to percutaneous leads.

CDI Structure and Foreign Ownership Considerations for Australian Investors in Saluda Medical

Saluda Medical’s securities trade on the ASX via CHESS Depositary Interests (CDIs) rather than ordinary shares. The company’s ARBN is 691 140 360, and it is incorporated in the United States with a registered address at 9401 James Ave S, Suite 132, Bloomington, Minnesota 55431. The CDI structure allows U.S.-incorporated companies to access Australian capital markets without a full domestic U.S. listing.

Saluda’s CDIs are issued under Regulation S of the U.S. Securities Act of 1933, as amended, and a no-action letter from the U.S. Securities and Exchange Commission staff. Consequently, the CDIs are not registered under the U.S. Securities Act, and holders face transfer restrictions. Specifically, CDI holders cannot offer, sell, pledge, or transfer CDIs into the U.S. or to U.S. Persons (as defined by Regulation S Rule 902(k)) for at least 12 months from the IPO allotment date unless a registration or exemption applies. Australian investors should consider these structural and jurisdictional factors when evaluating their holdings.

Investor Watchpoints Following CAP24’s Introduction to the U.S. Surgical Market

The first two U.S. surgical cases using CAP24 mark the start of its commercial launch rather than a completed milestone. Investors should monitor several forward-looking indicators as Saluda Medical advances CAP24’s rollout in the U.S. Key metrics include the number of trained and active implanting surgeons, procedure volumes, and management commentary on adoption rates within the surgical channel.

At this stage, the company has not disclosed revenue data, procedural volume targets, pricing, or a timeline for broader surgical rollout. The immediate impact on share price remains unclear. Upcoming milestones to watch include additional clinical case reports, commercial penetration within the 30% U.S. SCS market segment represented by paddle leads, and financial updates as CAP24 contributes to the overall Evoke Therapy program. Sector trends such as rising chronic back pain prevalence, aging populations in key markets, and growing clinical acceptance of closed-loop neuromodulation provide supportive tailwinds. Company-specific risks include competition in the spinal cord stimulation field, regulatory developments, and the pace of surgeon adoption of this novel paddle lead technology.