Saluda Medical Launches FDA-Approved Paddle Lead for Therapy

BLOOMINGTON, Minn., Oct. 6, 2026 /CourierPR/ -- Saluda Medical, Inc., a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform, has announced the full US commercial release of the CAP24™ Surgical Paddle Lead. The CAP24 is now broadly available to neurosurgery and orthopedic spine practices across the United States, following a successful limited market release in selected centers earlier this year.

The CAP24 is the first and only FDA-approved surgical paddle lead designed for physiologic, dose-controlled closed-loop therapy. It enables the Evoke® System to measure each patient's unique neural response and adapt stimulation with every pulse. Its low-profile, anatomically contoured design supports stable placement and broad coverage, making it an ideal solution for patients requiring a paddle lead.

During the limited release, physicians provided positive feedback on the device's performance and its integration into clinical practice. The CAP24 is the first surgical paddle lead designed to support dose-controlled therapy, providing real-time physiologic feedback to allow stimulation to be adjusted as neural responses change. This helps maintain consistent therapy delivery and a more predictable treatment experience.

The Paddle Lead is now available to neurosurgery and orthopedic spine practices across the United States, expanding access to the surgical segment, which represents approximately 30% of US spinal cord stimulation (SCS) implants. The full commercial release of CAP24 marks an important step towards making physiologic, dose-controlled closed-loop therapy available to all appropriate patients.

The Evoke Therapy, which has demonstrated durable clinical outcomes in the EVOKE study, is now accessible to a broader patient base. More than 90% of patients who responded at three months remained responders at 36 months. The 12-month results from the EVOKE study, the first and only prospective, multi-center, parallel-arm, double-blind, randomized controlled pivotal study with a voluntary crossover arm in SCS, demonstrated clinically superior pain relief to open-loop therapy. These results were published in The Lancet Neurology and JAMA Neurology, with 36-month data showing sustained pain relief in the same publication.

The Evoke System, the first product of Saluda Medical, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. It is designed to treat chronic neuropathic pain by providing spinal cord stimulation (SCS) therapy that senses and measures neural activation to optimize therapy and reduce patient and clinician burden.

Saluda Medical's CHESS Depositary Interests (CDIs) are issued in reliance on Regulation S under the U.S. Securities Act of 1933, as amended, and a no-action letter issued by the staff of the U.S. Securities and Exchange Commission. Accordingly, the Company's CDIs have not been, and will not be, registered under the U.S. Securities Act (except pursuant to an effective registration statement) or the securities laws of any state or other jurisdiction in the United States. The holders of Saluda's CDIs may not offer, sell, pledge, or otherwise transfer the CDIs into the United States or to, or for the account or benefit of, a "U.S. Person" (as defined in Rule 902(k) of Regulation S under the U.S. Securities Act) for a period of at least 12 months from the allotment date under the IPO.

The CAP24 Surgical Paddle Lead represents a significant advancement in the treatment of chronic neurological conditions, offering a more personalized and effective therapy for patients who require a paddle lead. This development underscores Saluda Medical's commitment to developing innovative treatments and expanding access to cutting-edge medical technology.