Publication of results from two-year, double-blind, randomized controlled trials of EVOKE in neurology JAMA demonstrates sustained superiority of closed-loop Evoke® over open-loop spinal cord stimulation

ARTARMON, Australia, January 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 based on advanced closed-loop technologies designed to treat neurological disorders debilitating drugs, today announced long-term results from its level 1 double-blind randomized controlled trial (RCT) EVOKE published online in JAMA Neurology. This follows the 12-month EVOKE study results previously published in Lancet Neurology. The EVOKE study is the first pivotal double-blind spinal cord stimulation (SCS) RCT and includes the longest follow-up period of any SCS study with a 36-month follow-up. The study is the first to assess 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 wide range of electric field strengths reaching the spinal cord due to changes in the distance between the stimulation electrode and the nerves. These changes in distance are caused by normal physiological activity (for example, breathing and heart rate) and movement, resulting in variable nerve activation. evocation^® The system is designed to address these limitations by constantly optimizing therapy dosage and pain relief by instantly measuring and adjusting stimulation at the microsecond level using ECAP-controlled closed-loop SCS technology. Evoke is an investigational device in the United States and is limited by federal law to experimental use. Evoke is not approved or available for sale in the United States until it receives FDA approval.

Two-year results demonstrate that Evoke’s superior 12-month closed-loop pain relief results were sustained for up to 24 months and that Evoke’s closed-loop patients show greater long-term improvements in the patient-reported results as open-loop patients, with quality-of-life improvements close to normative values ​​for the US population despite the severity of baseline chronic pain. Evoke’s primary and secondary closed-loop results are as good or better than results presented in any previous 24-month spinal cord stimulation RCTs and demonstrate that Evoke closed-loop patients show improvements in spinal cord stimulation. many aspects of their health, with a majority experiencing clinically important differences in functional capacity, quality of life, sleep and mood with significant reductions in opioid use.¹

Significant Evoke ECAP-controlled closed-loop results in the 24-month EVOKE study include:

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

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

“In my opinion, the EVOKE study demonstrated, through rigorous clinical evidence, that closed-loop spinal cord stimulation controlled by ECAP is poised to provide patients with chronic pain a remarkable opportunity to improve. their overall health and live a pain-free life. noted Nagy Mekhail, MD, PhD, professor at the Cleveland Clinic Lerner College of Medicine, director of research and education in evidence-based pain medicine in the Department of Pain Management at the Cleveland Clinic, and senior author and monitor study of the EVOKE study. “These unprecedented results have the potential to set new clinical standards for the treatment of chronic pain, and I believe the results are due to the new technology in the Evoke System which is designed to instantly measure the spinal cord response. to stimulation and automatically adjust to maintain consistent therapy in and out of the clinic. “

The full two-year publication of the EVOKE study in JAMA Neurology is accessible at the address: https://jamanetwork.com/journals/jamaneurology/fullarticle/2788004

About the American pivotal study Evoke

The American pivotal study Evoke is the first American double-blind, randomized and controlled pivotal study in the field of spinal cord stimulation. The trial was conducted at 13 sites in the United States and followed a total of 134 patients. Patients were randomized 1: 1 to receive ECAP-controlled closed-loop SCS or open-loop SCS. The same neuromodulation system (Evoke System) served as the investigation 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 and stored ECAPs.

About Saluda Medical

Saluda Medical is a global company with a mission to revolutionize the field of neuromodulation with an emerging portfolio of therapies based on 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 disease that affects more than 540 million people worldwide, reading, recording and responding instantly to the response of the nerves to stimulation to provide continually optimized therapy. Evoke is an investigative device in United States and is limited by federal law to experimental use. It is not available for sale in United States and will not be available for sale until approved by the FDA. SCS is designed to treat chronic pain by stimulating the spinal cord and modifying the transmission of pain signals to the brain. To find out more, visit www.saludamedical.com.

^1. There was statistically significant and clinically significant improvement from baseline at 24 months in both treatment groups in all other patient-reported outcomes, including profile of mood states, the survey abridged in 12 elements, the Oswestry Disability Index, the Pittsburgh Sleep Quality Index, and the five-level five-dimensional European Quality of Life. There was no difference between groups in adverse events related to stimulation therapy.

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

^?? At 24 months, there had been 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 arm in open loop).

SOURCE Saluda Medical