Saluda Medical (ASX: SLD) Receives FDA Approval for CAP24 Surgical Paddle Lead

Key Highlights

• Saluda Medical (ASX: SLD) has received US FDA approval for its CAP24 Surgical Paddle Lead.
• Approval opens access to the surgical spinal cord stimulation market, representing around 30% of US SCS implants.
• CAP24 is the first FDA-approved paddle lead purpose-built for closed-loop neuromodulation.
• Commercial rollout is scheduled to begin in the second half of 2026 through a phased launch.
• Shares rose 14.02% to $0.468 following the announcement.

Saluda Medical (ASX: SLD) has reached a major commercial milestone after receiving approval from the US Food and Drug Administration (FDA) for its CAP24 Surgical Paddle Lead, expanding the reach of its Evoke Spinal Cord Stimulation (SCS) System into a sizeable new segment of the US pain management market.

While FDA approvals are common milestones for medical technology companies, this one materially broadens Saluda’s commercial opportunity. Until now, the company’s Evoke System was limited to physicians using percutaneous leads. CAP24 allows Saluda to compete in surgical spinal cord stimulation procedures performed by neurosurgeons and orthopaedic spine surgeons, a segment that accounts for approximately 30% of all spinal cord stimulation implants in the United States.

The market responded positively to the announcement, with Saluda shares climbing 14.02% to $0.468 by afternoon  on Tuesday. Despite the rally, the stock remains down 82.45% over the past 12 months, giving the company a market capitalisation of approximately A$117.2 million.

Source: MarketIndex 

Expanding the Evoke ecosystem

Rather than introducing a new therapy platform, CAP24 expands the capabilities of Saluda’s existing Evoke ecosystem.

The device has been purpose-built for the company’s proprietary closed-loop neuromodulation technology and integrates with both the Evoke System and EVA Sensing Technology. Unlike conventional open-loop spinal cord stimulators that deliver fixed levels of stimulation, Saluda’s system continuously measures the body’s neural responses through Evoked Compound Action Potentials (ECAPs) and automatically adjusts therapy in real time.

The newly approved CAP24 features 24 electrodes arranged in a three-column design, providing broader anatomical coverage, stable placement during surgery and continuous ECAP sensing.

That combination is designed to deliver more personalised pain management while supporting consistent therapy over time.

Opening a larger market

Perhaps the biggest significance of the approval is the immediate expansion of Saluda’s addressable market.

Previously, the company’s commercial team primarily targeted pain physicians performing minimally invasive percutaneous procedures. FDA approval now enables the same sales organisation to engage neurosurgeons, orthopaedic surgeons and hospital surgical programs without building an entirely new product platform.

Management believes this should improve sales force productivity, increase procedure coverage and deepen relationships within existing hospital accounts while creating opportunities to enter new surgical centres.

Commercial rollout will begin gradually during the second half of 2026, with the initial phase focused on surgeon education, inventory deployment and selected customer sites before a broader expansion later in the year.

Importantly, the company has cautioned that revenue growth is expected to build progressively rather than immediately.

Standing out in a competitive market

The spinal cord stimulation market is dominated by global medical technology companies including Medtronic, Boston Scientific, Abbott and Nevro.

Most competing systems continue to rely on open-loop stimulation, making Saluda’s closed-loop approach one of its key competitive differentiators.

The technology is supported by data from the EVOKE clinical trial, a randomised controlled study that demonstrated superior pain relief with sustained outcomes over 36 months.

As healthcare providers increasingly seek evidence-based technologies, long-term clinical data may help strengthen Saluda’s position as it expands into the surgical market.

Leadership sees a new phase of growth

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

He said CAP24 was purpose-built specifically for closed-loop therapy rather than adapted from an existing paddle lead design. Regan added that the approval enables surgeons and clinicians to make fuller use of the Evoke platform while extending Saluda’s proprietary technology into a broader range of spinal cord stimulation procedures.

Independent clinical support also accompanied the announcement.

Dr Erika Petersen from the University of Arkansas for Medical Sciences said CAP24 was clearly designed with closed-loop therapy in mind, noting that its anatomical design and stable placement support precise implantation. She added that the integration of the lead with Evoke and EVA Sensing Technology enables objective, physiology-based neuromodulation and represents an important advancement for spinal cord stimulation.

The next challenge is commercial execution

While the regulatory hurdle has now been cleared, Saluda’s next phase depends on execution.

The company must train surgeons, establish hospital inventory, build clinical adoption and compete against well-established rivals with larger sales networks and longstanding customer relationships.

Still, the approval changes the conversation around Saluda. Rather than being limited to one segment of the spinal cord stimulation market, the company now has access to a significantly broader customer base using the same proprietary technology platform.

For Saluda Medical, the FDA decision is more than another regulatory approval. It is a strategic expansion that could strengthen the commercial reach of the Evoke ecosystem and create a new pathway for growth in one of the world’s largest medical device markets.

Source: Saluda Medical ASX Announcement (30 June 2026), US Food and Drug Administration (FDA), EVOKE Clinical Trial data.