Highlights

  • Saluda Medical shares rose 14.63% to AUD 0.47 on 30 June 2026 after announcing U.S. FDA approval for its CAP24 surgical paddle lead.
  • The approval expands the company's U.S. addressable market by enabling it to target neurosurgeons and orthopedic surgeons, who account for around 30% of spinal cord stimulation (SCS) implants in the U.S.
  • A phased U.S. commercial launch is scheduled to begin in the second half of calendar year 2026, with a broader rollout planned later in the year.
  • CAP24 becomes the first and only spinal cord stimulation paddle lead specifically designed for physiologic closed-loop neuromodulation using the Evoke® System and EVA Sensing Technology.
  • The Evoke® System is supported by prospective randomized clinical evidence demonstrating durable outcomes through 36 months.

Saluda Medical Inc. (ASX:SLD) shares climbed 14.63% to AUD 0.47 during the morning trading session on 30 June 2026 after the company announced that the U.S. Food and Drug Administration (FDA) had approved its CAP24 surgical paddle lead for commercial sale in the United States. While the stock remains down approximately 62.99% over the past year, investors appeared to respond favourably to the regulatory milestone, which expands Saluda's addressable market and supports the company's commercial strategy in the U.S. spinal cord stimulation market.

Saluda Medical is a commercial-stage medical device company focused on treating chronic neurological conditions through its proprietary closed-loop neuromodulation platform. Its flagship Evoke® System automatically adjusts spinal cord stimulation based on real-time physiological feedback, differentiating it from conventional open-loop systems. The latest FDA approval broadens the company's product portfolio and enables wider adoption of its technology across additional surgical procedures.

FDA Approval Expands U.S. Commercial Opportunity

The newly approved CAP24 surgical paddle lead allows Saluda Medical to market and sell the device throughout the United States.

According to the company, paddle leads represent an alternative to percutaneous leads commonly used in spinal cord stimulation procedures. The approval enables Saluda to engage neurosurgeons and orthopedic surgeons, who generally prefer surgically implanted paddle leads when performing spinal cord stimulation procedures.

The company noted that these specialists account for approximately 30% of all spinal cord stimulation implants undertaken in the United States. As a result, the approval broadens Saluda's addressable market beyond its existing customer base, which has primarily focused on percutaneous lead procedures.

Management believes the additional product offering will also increase productivity across its existing U.S. commercial organisation by expanding procedural coverage within current customer accounts while creating opportunities to engage a broader range of surgeons.

Phased U.S. Launch Planned During 2026

Following FDA approval, Saluda intends to introduce CAP24 through a phased commercial launch beginning in the second half of calendar year 2026.

The company indicated that broader commercial rollout is expected later in calendar year 2026 as surgeon training programs progress and field inventory expands.

Saluda expects revenue contributions from the surgical channel to build gradually as adoption increases over time.

Rather than requiring a separate commercial infrastructure, the company plans to leverage its existing U.S. sales organisation to support adoption of the new product across both existing and new accounts.

CAP24 Broadens the Evoke® Product Portfolio

The CAP24 surgical paddle lead extends Saluda's spinal cord stimulation portfolio by allowing the Evoke® System with EVA Sensing Technology to be used in surgical paddle lead procedures.

According to the company, the product is the first and only spinal cord stimulation paddle lead specifically engineered for physiologic closed-loop neuromodulation.

Unlike conventional paddle leads that were originally developed for open-loop stimulation, CAP24 was designed specifically to work with Saluda's closed-loop technology.

The device enables therapy to be guided by each patient's own neural responses, supporting objective therapy optimisation through continuous physiological feedback.

This capability is intended to deliver more consistent spinal cord stimulation by automatically adjusting therapy based on measured neural activity.

Design Focuses on Stability and Precision

Saluda highlighted several design features incorporated into the CAP24 paddle lead.

The device incorporates a low-profile, anatomically contoured design intended to support stable placement during surgical implantation while providing broad lateral and longitudinal coverage.

According to the company, these features assist with consistent sensing of Evoked Compound Action Potentials (ECAPs), supporting reliable therapy delivery.

The paddle lead also incorporates a 24-electrode, three-column configuration that continuously senses and measures ECAPs.

Working together with the Evoke® System and EVA Sensing Technology, CAP24 enables automatic adjustment of spinal cord stimulation based on each patient's physiology rather than relying solely on fixed stimulation settings.

Clinical Evidence Supports the Evoke® System

Saluda stated that the Evoke® System is supported by prospective, randomised clinical evidence demonstrating durable patient outcomes through 36 months.

The company referenced published results from the EVOKE clinical trial, which compared ECAP-controlled closed-loop spinal cord stimulation with conventional open-loop therapy.

According to Saluda, 12-month findings from the study were published in The Lancet Neurology, while 24-month outcomes appeared in JAMA Neurology.

The company also noted that 36-month results, demonstrating sustained pain relief, were published in Regional Anesthesia and Pain Medicine.

These clinical findings continue to support the Evoke® System's use in managing chronic neuropathic pain through physiologically guided spinal cord stimulation.

Management Highlights Strategic Milestone

Chief Executive Officer Barry Regan described the FDA approval as an important milestone for the company.

He said CAP24 had been purpose-built to bring closed-loop therapy to surgical paddle lead procedures, enabling surgeons and clinicians to make broader use of the Evoke® System together with EVA Sensing Technology in these cases.

The company believes the approval strengthens its ability to serve additional physician groups while extending access to physiologic closed-loop neuromodulation across a wider range of spinal cord stimulation procedures.

Clinical Perspective on the New Device

Professor Erika Petersen, Professor of Neurosurgery at the University of Arkansas for Medical Sciences (UAMS), also commented on the approval.

She stated that CAP24 was designed specifically with closed-loop therapy in mind, highlighting its anatomical design, stability and integration with the Evoke® System and EVA Sensing Technology.

According to Professor Petersen, these features allow surgeons to deliver objective, physiology-based neuromodulation through a surgical paddle lead, representing an advancement in spinal cord stimulation procedures.

Building on Saluda's Closed-Loop Platform

The FDA approval further expands Saluda Medical's commercial portfolio centred around its proprietary closed-loop neuromodulation platform.

The company's technology continuously senses neural responses to stimulation and automatically adjusts therapy in real time based on physiological feedback.

Its Evoke® System is indicated for managing chronic intractable pain affecting the trunk and limbs, including pain associated with failed back surgery syndrome, chronic low back pain and leg pain.

The system has been developed to optimise therapy delivery while reducing the burden on both patients and clinicians through automated adjustment of stimulation based on measured neural activity.

The addition of CAP24 extends these capabilities into surgical paddle lead procedures, allowing more physicians to utilise Saluda's closed-loop technology.

What This Means for Investors

The FDA approval represents an important regulatory milestone for Saluda Medical as it broadens the company's commercial opportunity in the United States. By adding a surgical paddle lead to its product portfolio, Saluda can now target neurosurgeons and orthopedic surgeons responsible for around 30% of U.S. spinal cord stimulation implants, expanding beyond its existing percutaneous lead market. The company's phased commercial launch planned for the second half of calendar year 2026, together with the potential to increase procedural coverage within existing accounts, appears to have supported the positive share price reaction following today's announcement.