Saluda Medical Announces European Commercial Launch of Evoke, First and Only ECAP-Controlled

— World’s First Commercial Implants of the Evoke System Completed in The Netherlands

Saluda Medical Pty Limited (“Saluda Medical”) today announced the award of CE Mark and the European commercial launch of the Evoke(R) ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System for the treatment of chronic pain. The world’s first commercial implants were completed in The Netherlands.

Evoke is the first closed-loop SCS system that measures the spinal cord’s response to stimulation (via ECAPs, or evoked compound action potentials) and adjusts on every pulse to optimize activation within the patient’s therapeutic window.

Dr. Harold Nijhuis, Anesthesiologist and Pain Management Consultant at St. Antonius Hospital, Nieuwegein, The Netherlands, the first commercial user of Evoke worldwide, stated, “We have been anticipating the launch of the Evoke System for some time and are delighted to be the first commercial users of this important new technology. Our team is dedicated to providing patients with the most impactful innovations to help manage their chronic pain and we are already seeing positive initial results with the Evoke System. For the first time we can directly measure each individual patient’s neurophysiological response to SCS and use this objective data to guide how we program the system to best treat their individual pain complaint. This is a disruptive advance in the field of neuromodulation that will benefit a huge number of patients suffering with refractory pain conditions.”

Last week at the European Pain Federation, EFIC 2019, Dr. Nijhuis was invited to present two posters that highlighted the clinical advantage of the ability to measure the spinal cord’s response to stimulation. Nijhuis explained, “Without the ability to measure, we cannot overcome the variability of spinal cord activation. With Evoke SCS, we can set each patient’s individual therapeutic window and let the device adjust on every pulse, millions of times per day, to meet their need.”

John Parker, CEO of Saluda Medical,

/Public Release.