Publication of Two-Year EVOKE Double-Blind Randomized Controlled Trial Results in JAMA Neurology Demonstrate Sustained Superiority of Evoke® Closed-Loop over Open-Loop Spinal Cord Stimulation

ARTARMON, Australia, Jan. 10, 2022 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), a global company on a mission to revolutionize the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders, today announced long-term results of its double-blind Level 1 EVOKE randomized controlled trial (RCT) published online in JAMA Neurology. This follows the 12-month EVOKE Study results previously published in The Lancet Neurology. The EVOKE Study is the first double-blind, pivotal RCT in spinal cord stimulation (SCS) and includes the longest follow-up period of any SCS study with follow-up out to 36 months. The study is the first to evaluate the effectiveness of ECAP-controlled closed-loop SCS compared to open-loop SCS. The limitation of open-loop SCS systems is the lack of adjustment to the broad range of electrical field strength reaching the spinal cord due to changes in distance between the stimulation electrode and the nerves. These changes in distance are caused by normal physiological activity (e.g., breathing and heartbeat) and movement, which results in variable nerve activation. The Evoke^® System is designed to address these limitations through consistently optimizing therapy dosing and pain relief by instantaneously measuring and adjusting stimulation at the microsecond level through proprietary ECAP-controlled closed-loop SCS technology. Evoke is an investigational device in the U.S. and is limited by federal law to investigational use. Evoke is not approved or available for sale in the U.S until it receives approval by the FDA.

The two-year results demonstrate that Evoke closed-loop 12-month superior pain relief results were sustained out to 24 months and that Evoke closed-loop patients exhibit greater long-term improvements in patient-reported outcomes than open-loop patients, with quality-of-life improvements nearing normative values for the U.S. population despite the severity of baseline chronic pain. The Evoke closed-loop primary and secondary outcomes are as well as or better than outcomes presented in any previously conducted RCT spinal cord stimulation evidence at 24 months and demonstrate that Evoke closed-loop patients experience improvements across many aspects of their health, with a majority experiencing clinically important differences in functional ability, quality of life, sleep, and mood with meaningful reduction in opioid use.¹

Significant findings of Evoke ECAP-controlled closed-loop in the EVOKE Study at 24 months include:

• Superiority in treatment of overall back and leg pain and long-term pain reduction
• Highest long-term responder (≥50% relief) and high responder (≥80% relief) rates, 84% and 50%, respectively
• Highest reported improvements in overall quality of life, pain relief, ability to perform daily activities, sleep quality, mood, and opioid reduction²
• Statistically significant higher degree of spinal cord activation maintained within the therapeutic window (94% vs 46% for open-loop SCS)
• Quality of life improvements were better than other chronic pain treatments, such as lumbar decompression and fusion, and rival distinguished interventions for other conditions such as hip and knee arthroplasty
• Nearly 7 out 10 patients (66.7%) voluntarily reduced or eliminated opioids
• No explants due to loss of efficacy^†

In addition to these findings, the study demonstrated that Evoke closed-loop demonstrated a near elimination of reprogramming visits after 12 months saving clinician and clinic time for additional patient care.

"In my view, the EVOKE Study has demonstrated through rigorous clinical evidence that Evoke ECAP-Controlled Closed-Loop Spinal Cord Stimulation is poised to provide chronic pain patients with a remarkable opportunity to improve their total health and live a pain-free life," said Nagy Mekhail, MD, PhD, Professor at the Cleveland Clinic Lerner College of Medicine, Director of Evidence-Based Pain Medicine Research and Education in the Department of Pain Management at the Cleveland Clinic, and lead author and medical monitor for the EVOKE Study. "These unprecedented outcomes have the potential to set new clinical standards for chronic pain treatment, and I believe the results are due to the Evoke System's novel technology which is designed to instantaneously measure the spinal cord's response to stimulation and automatically adjust to maintain consistent therapy in and out of the clinic."

The full two-year EVOKE Study publication in JAMA Neurology can be accessed at: https://jamanetwork.com/journals/jamaneurology/fullarticle/2788004

About the U.S. Evoke Pivotal Study

The U.S. Evoke pivotal study is the first double-blinded, randomized, controlled U.S. pivotal study in the field of spinal cord stimulation. The trial was conducted at 13 sites throughout the U.S. and followed a total of 134 patients. Patients were randomized 1:1 to ECAP-controlled, closed-loop SCS or open-loop SCS. The same neuromodulation system (Evoke System) served as the investigational and control device, as it offered both ECAP-controlled closed-loop SCS and open-loop SCS. For both treatment groups, real-time spinal cord activation was determined from measured ECAPs and stored.

About Saluda Medical

Saluda Medical is a global company on a mission to revolutionize the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders. The company's first product, Evoke^®, is the only ECAP-controlled closed-loop spinal cord stimulation (SCS) system designed to treat chronic pain, a condition that affects more than 540 million people globally, by instantaneously reading, recording, and responding to the nerves' response to stimulation to provide continually optimized therapy. Evoke is an investigational device in the United States and is limited by federal law to investigational use. It is not available for sale in the United States and will not be available for sale until it is approved by the FDA. SCS is designed to treat chronic pain by stimulating the spinal cord and altering the transmission of pain signals to the brain. To learn more, visit www.saludamedical.com.

^1. There was statistically significant and clinically meaningful improvement from baseline at 24 months in both treatment groups in all other patient-reported outcomes including Profile of Mood States, 12-item Short Form Survey, Oswestry Disability Index, Pittsburgh Sleep Quality Index, and European Quality of Life Five-Dimensional Five-Level. There were no differences between groups in stimulation therapy-related adverse events.

^2. In reference to supplement eTable 1. 24-Month RCT Evidence for SCS; SF-12, VAS, ODI, PSQI, POMS, and opioid reduction

^† At 24 months, there were no explants due to loss of efficacy in the closed-loop arm. There were a total of 2 explants due to loss of efficacy in the open-loop arm, and a total of 3 explants due to procedure-related infections (2 in the closed-loop arm, 1 in the open-loop arm).

SOURCE Saluda Medical