MINNEAPOLIS, Jan. 23, 2025 - Saluda Medical, Inc., a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, today announced United States (U.S.) Food & Drug Administration (FDA) approval for its biomarker-based, automated patient programming platform in spinal cord stimulation (SCS), representing a significant advancement for SCS therapy. The new programming platform, EVA™, is compatible with all commercially implanted Evoke® System patients in the U.S.
EVA is designed to improve the SCS patient programming experience by automating manual programming steps and autonomously scanning and analyzing a patient's nerves to optimize therapy settings. This automated programming workflow has the potential to minimize the burden of care by substantially reducing the time element of programming and elevating the overall patient experience, while simultaneously improving daily clinic throughput in busy pain practices.
The innovation behind EVA is powered by sensing, measuring, and adjusting stimulation based on each patient's unique biomarker response, known as evoked compound action potentials (ECAPs).
"With the added benefit of an automated programming workflow, the Evoke System is better positioned to transform the SCS category than ever before," said Timothy Deer, MD, President and CEO, The Spine & Nerve Center of the Virginias, and Clinical Professor of Anesthesiology and Pain Medicine, WVU School of Medicine. "EVA has the potential to usher in new benefits for clinicians and staff with greater ease of use, faster and more consistent programming, and monitoring physiological data to adjust settings to an optimal therapeutic dose."
Clinical data on EVA™ will be presented at the North American Neuromodulation Society (NANS) Annual Meeting, to be held in Orlando, FL from January 30 – February 1, 2025, where further insights into the platform's impact on patient programming will be shared.
"We witnessed the sophisticated therapy optimization of EVA occur in less than 13-minutes, the benefits of which could have a tremendous impact on improving patient outcomes while simultaneously increasing clinic efficiencies," said Jason Pope, MD, principal investigator of the Prospective Dose-Controlled Closed-Loop Study, and Founder and CEO, Evolve Restorative Center.
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/.
Saluda and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.
Investor Contacts:
Brian Johnston or Sam Bentzinger
brian@gilmartinir.com
sam@gilmartinir.com
SOURCE Saluda Medical
