BLOOMINGTON, Minn., Oct. 6, 2026 /PRNewswire/ -- Saluda Medical, Inc. (ASX: SLD, "Saluda" or the "Company") a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform, today announced the full US commercial release of the CAP24 Surgical Paddle Lead following FDA approval earlier this year. CAP24 is now being made broadly available to neurosurgery and orthopedic spine practices across the US, following completion of a successful limited market release in selected centers. During the limited release, physicians provided positive feedback on the device's performance and its integration into clinical practice.
CAP24 is the first and only FDA-approved surgical paddle lead purpose-built 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.
"CAP24 is the first surgical paddle lead designed to support dose-controlled therapy," said Erika Petersen, MD, Professor of Neurosurgery at the University of Arkansas for Medical Sciences. "By providing real-time physiologic feedback, it allows stimulation to be adjusted as neural responses change, helping maintain consistent therapy delivery and a more predictable treatment experience."
The Paddle Lead is now available to neurosurgery and orthopedic spine practices across the US, expanding access to the surgical segment, which represents approximately 30% of US spinal cord stimulation (SCS) implants.
"EvokeTM Therapy has changed what patients and treating physicians can expect from SCS. Until recently, it has only been available through percutaneous leads," said Mike Mathias, Chief Executive Officer of Saluda Medical. "The full commercial release of CAP24 expands access to our one-of-a-kind therapy for patients who require a paddle lead. This marks an important step towards making physiologic, dose-controlled closed-loop therapy available to all appropriate patients."
CAP24 is designed to deliver Evoke Therapy, which has demonstrated durable clinical outcomes in the EVOKE study. More than 90% of patients who responded at three months remained responders at 36 months.1
1.Mekhail NA, et al. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med.
This announcement has been authorized for release by Saluda Medical's Disclosure Committee.
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About Saluda Medical
Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel neuromodulation platform. The Company's closed-loop, dose-control platform senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback. The Company's first product, the Evoke System, 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, and 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. 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, that demonstrated clinically superior pain relief to open-loop therapy, were published in The Lancet Neurology, 24-month results were published in JAMA Neurology, and 36-month data, that demonstrated sustained pain relief, were published in Regional Anesthesia and Pain Medicine. To learn more, including risks and important safety information, visit www.saludamedical.com/us/safety/.
Foreign Ownership Restriction
Saluda's CHESS Depositary Interests (CDIs) are issued in reliance on Regulation S under the U.S. Securities Act of 1933, as amended (the U.S. Securities Act), 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, unless the resale of the CDIs is registered under the U.S. Securities Act or an exemption from registration is available.
SOURCE Saluda Medical
