Saluda Medical Announces Late Breaking Data at NANS 2024 Annual Meeting

2024-01-16

Closed-Loop with Precise Neural Dosing Associated with Superior Outcomes

MINNEAPOLIS, Jan. 16, 2024 /PRNewswire/ -- Saluda Medical, Inc., a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced the company's data will be presented at the North American Neuromodulation Society (NANS) 2024 Annual Meeting, taking place January 18-21.

The 3-Year EVOKE Study demonstrated superior pain relief in the closed-loop (SmartLoop™) arm versus the open-loop arm. In the late-breaking presentation, EVOKE Study data will be shown that SmartLoop therapy is associated with significantly better adherence to prescribed electrical dose versus the open-loop arm. This evidence may usher in a new era of objective therapy measures that enable improved long-term clinical outcomes for spinal cord stimulation (SCS).

Precise neural dosing with SmartLoop is possible through real-time measurements of evoked compound action potentials (ECAPs), which are direct measures of the nerve fibers' response to stimulation.

In addition to the late-breaking presentation, the 13 posters and presentations to be presented at NANS include additional data on long-term SCS clinical results and neural monitoring to optimize SCS long-term therapy efficacy as well as identify responders from non-responders during the SCS trial evaluation phase.

Podium presentations include:

Late Breaking Session: 3-Year Durable Outcomes and Dose-Response with ECAP Closed-Loop spinal cord stimulation (SCS) for Treatment of Chronic Pain, Dr. Nagy Mekhail (EVOKE RCT)

Attaining Maximal Analgesic Effect (MAE) With Objective Neurophysiological Measurements, Dr. Robert Levy (EVOKE RCT)

Increasing Treatment Response After 2 Years of Open-Loop SCS Therapy: Crossover Patient Insights Dr. Jason Pope, (EVOKE RCT)

Big ECAP Data: A Novel Objective Neural Panel™ for SCS Therapy Optimization, Dr. Ajay Antony (EVOKE RCT, Avalon Study, and DR Study)

"Saluda Medical has been on a journey to transform neuromodulation and solve large unmet clinical and health economic needs. The evidence presented at NANS demonstrates SmartLoop's capability to provide long-term superior outcomes for patients as well as advance SCS therapy efficiencies for clinical practices," said Jim Schuermann, President and CEO of Saluda Medical.

For more information, please visit us at NANS: Saluda

Medical Booth #339.

About Saluda Medical

Saluda Medical is a global company transforming patients' lives with disruptive neural sensing technologies designed to revolutionize the field of neuromodulation. The company's first product, the Evoke® System, is the only SmartLoop™ therapy with physiologic ECAP-controlled closed-loop spinal cord stimulation (SCS) and 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. The Evoke® System automatically reads, records, and responds to the nerves' response to stimulation 4+million times a day to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology, 24-month results have been published in JAMA Neurology, and unprecedented 36-month data, demonstrating enduring and consistent pain relief results were published in Regional Anesthesia and Pain Medicine. To learn more, including risks & important safety information, visit www.saludamedical.com/us/safety/.