Saluda Medical Given FDA Approval to Market CAP24 Paddle Lead to US Neurosurgeons

Commercial-stage medical device company Saluda Medical (ASX: SLD) has received US Food and Drug Administration (FDA) approval for its CAP24 paddle lead to treat chronic neurological conditions, allowing it to be marketed and sold in the country.

Paddle leads are an alternative to traditional percutaneous leads used by neurosurgeons and orthopedic surgeons in spinal cord stimulation (SCS) procedures, which account for 30% of all SCS implants in the US.

Regulatory approval is expected to significantly expand Saluda’s addressable market and growth profile beyond its current percutaneous lead-focused customer base.

The company has planned a phased US launch of CAP24 before year end, as well as a broader commercial rollout as surgeon training and field inventory scale.

Purpose-Built Device

CAP24 is the first and only SCS paddle lead purpose-built to deliver the physiologic closed-loop neuromodulation offered by Saluda’s Evoke SmartLoop system.

Evoke is used for the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, as well as severe lower back and leg pain.

The product enables therapy informed directly by each patient’s unique neural signals based on a low-profile, anatomically contoured design featuring a unique 24-electrode, three-column configuration.

It senses and measures evoked compound action potentials, working with Evoke and Saluda’s next-generation EVA sensing technology to automatically adjust stimulation to each patient’s physiology.

This enables objective optimisation and consistent personalised therapy with precision beyond human capability.

Closed-Loop Therapy

Saluda Medical chief executive officer Barry Regan described the FDA approval as an “important milestone” for the company.

“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 CAP24 paddle was clearly designed with closed-loop therapy in mind,” Dr Erika Petersen, Professor of Neurosurgery at the University of Arkansas for Medical Sciences, added.

“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—an important advancement for spinal cord stimulation.”

Saluda—which made its Australian Securities Exchange debut in December after a $230 million public offering to underpin its US commercial expansion plans for the Evoke system—is targeting a large and under-penetrated market with an estimated value of more than $26 billion in the US alone.