Saluda Medical has obtained FDA approval for its CAP24 surgical paddle lead, a first-of-its-kind device designed for closed-loop spinal cord stimulation, poised to broaden its US market reach and engage new surgical specialties.
- FDA approves CAP24 paddle lead for US market
- Targets neurosurgeons and orthopedic surgeons covering 30% of US SCS implants
- First paddle lead engineered for closed-loop neuromodulation
- Phased US launch planned from second half of 2026
- Clinical evidence supports durable therapy outcomes to 36 months
FDA Approval Opens New Surgical Channel
Saluda Medical (ASX:SLD) has cleared a significant regulatory hurdle with the US Food and Drug Administration's approval of its CAP24 surgical paddle lead. This approval permits Saluda to market and sell the device in the US, unlocking access to neurosurgeons and orthopedic surgeons who prefer paddle leads during spinal cord stimulation (SCS) procedures. These specialists represent roughly 30% of all SCS implants in the US, substantially broadening Saluda's addressable market beyond its existing focus on percutaneous leads.
Innovative Design Tailored for Closed-Loop Therapy
The CAP24 paddle lead stands out as the first SCS paddle lead purpose-built for closed-loop neuromodulation, integrating seamlessly with Saluda's Evoke System and EVA Sensing Technology. Unlike traditional paddle leads designed for open-loop stimulation, CAP24 features a low-profile, anatomically contoured design with a unique 24-electrode, three-column configuration. This enables stable placement and consistent sensing of evoked compound action potentials (ECAPs), allowing automatic adjustments of stimulation based on real-time neural feedback. Such physiology-informed therapy aims to optimise pain relief while reducing clinician burden.
Commercial Rollout and Market Implications
Saluda plans a phased US launch commencing in the second half of 2026, with broader commercial availability expected later in the year as surgeon training and inventory ramp up. Management anticipates the surgical channel will gradually contribute to revenues, enhancing productivity within its US commercial operations by expanding procedural coverage within existing accounts. The addition of CAP24 is positioned to engage a wider surgeon base, potentially accelerating adoption of Saluda's closed-loop SCS platform.
Clinical Evidence Supports Durability
The Evoke System, supported by the CAP24 paddle lead, benefits from prospective, randomised clinical trials demonstrating durable pain relief outcomes sustained through 36 months. This evidence base underpins Saluda's closed-loop approach, which contrasts with traditional open-loop therapies. Clinical experts, including Dr Erika Petersen from the University of Arkansas for Medical Sciences, have praised CAP24’s design and integration for enabling physiology-based neuromodulation in surgical paddle lead procedures, marking an advancement in SCS therapy.
Bottom Line?
Saluda's FDA approval for CAP24 opens a new surgical pathway in the US, but market penetration and revenue growth will hinge on surgeon adoption and training progress through 2026.
Questions in the middle?
- How quickly will neurosurgeons and orthopedic surgeons adopt the CAP24 paddle lead in clinical practice?
- What impact will CAP24 have on Saluda’s overall US revenue trajectory in FY27 and beyond?
- Could competitors respond with their own closed-loop paddle leads, intensifying market competition?