Saluda Medical Announces Full U.S. Launch of EVA™ Sensing Technology for Use with the Evoke® SmartLoop™ System

New Clinical Data on EVA to be Presented at ASPN 2025 Annual Conference

MINNEAPOLIS, July 17, 2025 /PRNewswire/ -- 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 the full commercial launch of EVA, its next-generation sensing technology, in the United States (U.S.). EVA received U.S. Food & Drug Administration (FDA) approval in December 2024 and is compatible with all commercially implanted Evoke^® SmartLoop™ System patients.

EVA, an extension of the Evoke System, objectively scans and analyzes a patient's spinal cord to deliver personalized therapy with precision beyond human capability.  The Evoke SmartLoop System optimizes patient outcomes by sensing, measuring, and adjusting stimulation based on each patient's neural response biomarker, known as the evoked compound action potential (ECAP), to maintain therapy at the patient's prescribed level.

"This full commercial launch represents a significant advancement in SCS therapy and delivers on the promise of objective dosing and more effective pain relief for patients," said Mike Mathias, Chief Commercial Officer at Saluda Medical. "In addition to its clinical benefits, EVA automates manual programming steps, thereby improving the patient experience. Since receiving FDA approval at the end of last year, EVA has been utilized in over 3,000 commercial patient visits through a limited market release."

New clinical data to be presented at the American Society of Pain and Neuroscience (ASPN) 2025 Annual Conference, to be held July 17 – 20, 2025 in Miami, FL, will feature 11 abstracts and one oral presentation, which add to Saluda Medical's significant body of existing clinical evidence, including over 37 total publications. Among these are results from the landmark EVOKE Study, which demonstrated long-term efficacy out to 36-months.

"The Evoke SmartLoop System with EVA provides objective dosing that enables more predictable and durable outcomes in SCS," said Jason Pope, MD, Founder and CEO, Evolve Restorative Center. "The data premiering at ASPN 2025 further demonstrates the compelling clinical benefits of the Evoke SmartLoop System, including increasing the diagnostic value of the trial phase and maintaining therapy response over time without loss of efficacy."

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
[email protected] 
[email protected]

SOURCE Saluda Medical