Saluda Medical's CAP24 FDA Approval: A New Era for Surgical Pain Relief

BLOOMINGTON, Minn. – June 30, 2026 – Saluda Medical has secured U.S. Food and Drug Administration (FDA) approval for its CAP24™ surgical paddle lead, a landmark decision that significantly expands the reach of its pioneering closed-loop neuromodulation technology. The approval allows the company to market its Evoke® System to neurosurgeons and orthopedic surgeons, a critical physician group that performs approximately 30% of all spinal cord stimulation (SCS) procedures in the United States and has a strong preference for surgically implanted paddle leads.

This strategic milestone positions Saluda Medical to compete directly in a market segment previously beyond its reach, offering a technologically distinct solution for patients suffering from chronic intractable pain. The CAP24™ lead is designed to work exclusively with the company's Evoke® System, which is the only SCS platform capable of sensing the body's neural response to stimulation and automatically adjusting therapy in real time.

Expanding the Horizon of Chronic Pain Management

The FDA's decision is more than a product line extension; it's a strategic entry into a lucrative and established segment of the multi-billion-dollar SCS market. Dominated by industry giants like Medtronic, Boston Scientific, and Abbott, the surgical paddle lead market has long been a standard of care for specific patient cases. By introducing a paddle lead purpose-built for its advanced closed-loop system, Saluda is not just joining the competition—it is redefining the technological standard.

Until now, Saluda's commercial efforts centered on its percutaneous lead, primarily used by pain management physicians. This new approval unlocks a substantial portion of the market where surgeons prefer paddle leads for their stability and broad coverage. The financial markets responded swiftly to the news, with Saluda Medical's stock (ASX: SLD) climbing nearly 15% on the day of the announcement, reflecting investor confidence in the company's expanded growth profile.

Analysts project significant growth for the company, with revenue forecast to grow 38% per annum on average over the next three years. Saluda has reaffirmed its fiscal year 2026 revenue guidance of US$85.0 million, anticipating accelerated growth in the second half of the year. However, industry experts caution that the transition from regulatory approval to substantial revenue generation is a marathon, not a sprint. A phased U.S. launch is planned for the second half of 2026, with a broader rollout to follow as surgeon training and field inventory scale. Material revenue from the new paddle lead is anticipated to build gradually over the next 18 to 36 months.

"The FDA approval of the CAP24 surgical paddle lead marks an important milestone for Saluda Medical," said Barry Regan, Chief Executive Officer of Saluda Medical. "CAP24 was engineered from the ground up to bring closed-loop therapy to surgical paddle lead procedures, enabling surgeons and clinicians to more fully leverage the benefits of the Evoke System and EVA Sensing Technology in these cases."

The Science of Personalized Neuromodulation

At the heart of Saluda's innovation is its physiologic closed-loop technology. Traditional open-loop SCS systems deliver a constant level of stimulation, which must be manually adjusted by the patient or clinician. This can lead to periods of uncomfortable overstimulation or ineffective under-stimulation as a patient's needs change throughout the day. Saluda's Evoke® System fundamentally changes this paradigm.

Using its proprietary EVA™ Sensing Technology, the system measures evoked compound action potentials (ECAPs)—the direct neural response of the spinal cord to stimulation. This real-time neurophysiological feedback allows the device to automatically adjust stimulation to remain within the patient's therapeutic window, providing consistent and optimized therapy without conscious effort. The Evoke System is backed by robust clinical evidence, with a 36-month randomized controlled trial demonstrating that its closed-loop therapy provides clinically superior and sustained pain relief compared to open-loop systems.

The CAP24™ paddle lead is the first and only surgical lead engineered specifically to facilitate this intelligent feedback loop. Its unique 24-electrode, three-column configuration and low-profile, anatomically contoured design are optimized for stable placement and reliable ECAP sensing. This ensures the Evoke® System receives the high-fidelity data needed to deliver its objective, personalized therapy, a feature that distinguishes it from all other paddle leads on the market, which were originally designed for open-loop stimulation.

Designed for the Surgeon, Built for the Patient

Neurosurgeons and orthopedic surgeons often prefer paddle leads for their inherent stability. Implanted via a small incision in the spine called a laminotomy, these leads are less prone to migrating or shifting than percutaneously placed leads, which can reduce the need for revision surgeries and ensure more consistent therapeutic coverage. The CAP24™ was designed with these surgical preferences in mind.

"The CAP24 paddle was clearly designed with closed-loop therapy in mind," commented Erika Petersen, MD, Professor of Neurosurgery at the University of Arkansas for Medical Sciences (UAMS). "Its anatomical design, stability, and integration with the Evoke System and EVA Sensing Technology allow surgeons to deliver objective, physiology-based neuromodulation in a surgical paddle lead, which is an important advancement for spinal cord stimulation."

Saluda's commercial strategy leverages this surgeon-centric design. The company's existing sales force can now approach hospital systems with a comprehensive SCS portfolio, catering to the procedural preferences of both interventional pain physicians and surgeons. This creates a powerful synergy, enabling a single sales representative to support the full spectrum of SCS procedures within an institution, thereby increasing procedural coverage and enhancing productivity.

For the millions of Americans living with chronic, intractable pain, this approval means greater access to a non-opioid therapy that adapts to their unique physiology. By combining the procedural benefits preferred by surgeons with the demonstrated clinical superiority of its closed-loop system, Saluda Medical is offering a new level of care. With the CAP24™ now cleared for the U.S. market, Saluda Medical is positioned not only to compete but to lead in a new era of intelligent, patient-centric pain management.