Saluda Medical Announces Publication of 24-Month Spinal Cord Stimulation Results with the Evoke® System

Results show ~90% overall back and leg responder rate, ~68% high responder rate, and zero explants due to loss of efficacy

~83% of patients reduced or eliminated opioid use

Need for patient re-programming visits nearly eliminated after 12 months

Represents the first peer reviewed SCS study to show responder and high responder rate improvement over time

News provided by

Saluda Medical

May 10, 2021, 08:30 ET

ARTARMON, Australia, May 10, 2021 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), the market leader in the development of closed-loop spinal cord stimulation (SCS) for the treatment of chronic pain, today announced the publication of 24-month results from the prospective, multicenter, open-label Avalon Study in Pain Practice, the official journal of the World Institute of Pain. The study is the world's first multicenter spinal cord stimulation study to demonstrate these levels of profound pain relief scores and functional outcome measures at 24 months highlighting the restorative benefits for patients implanted with Saluda's proprietary Evoke^® Spinal Cord Stimulation (SCS) System.

The published results can be accessed here: ECAP–Controlled Closed–Loop Spinal Cord Stimulation Efficacy and Opioid Reduction over 24–Months: Final Results of the Prospective, Multicenter, Open–Label Avalon Study

In publishing these results, Evoke has set a new standard for clinical studies of SCS therapy evaluating patients through 24 months. Outcome measures in the Avalon Study approached normal levels in quality of life scores while reducing or eliminating opioids in most patients. Importantly, zero patients were explanted due to loss of efficacy and re-programming visits steadily declined over the course of the study.

"The 24-month data from the Avalon Study continues to highlight the Evoke Closed-Loop System's ability to restore patients' lives," said Dr. Charles Brooker, Director of the Pain Management and Research Centre, Royal North Shore Hospital, New South Wales, Australia, and lead author on the 24-month publication, "The investigators' and patients' experience suggests Saluda's closed-loop technology could be an alternative or replacement to opioids in chronic back and leg pain patients. I feel the profound pain relief and functional, quality of life, and sleep improvements demonstrated indicate Evoke has become one of the most important tools in our armamentarium to treat chronic pain."

Saluda is pioneering the field of closed-loop SCS with the introduction of the Evoke System, which is designed to provide real-time customization of waveforms to each patient's unique ECAP at the same rate as the stimulation frequency (>100 times per second).¹ The Evoke Closed-Loop System is designed to provide consistent therapy within a patient's preferred levels and avoid periods of over and under-stimulation.

Important Avalon Study 24-month highlights include:

89.5% of patients were responders (³50% pain relief) and 68.4% were high responders (³80% pain relief)
Responder and high responder rates improved over time

Responders: 81.4% at 12 months improved to 89.5% at 24 months
High Responders: 53.5% at 12 months improved to 68.4% at 24 months

82.8% of patients reduced or eliminated opioids with 41.4% of patients reducing to 0 MMEs at 24 months
Patient re-programming visits reduced to <1 per year after 12 months
Zero patients underwent explantation due to loss of efficacy
>80% experienced a clinically meaningful improvement in quality of life
>50% reported a clinically significant improvement in sleep (based on PSQI)

"Our mission is to transform the lives of patients living with chronic neuropathic pain by equipping our therapy with the most advanced measurement and response technology. We believe this will translate into breaking down barriers due to cost, service burden, and invasiveness thus ensuring broad patient access," said Jim Schuermann, CEO of Saluda Medical. "The Avalon Study demonstrates to the clinical community the long-term outcomes that can be achieved with the Evoke Closed-Loop SCS System. We'd like to thank all the Avalon investigators, clinical coordinators, nurses, their teams, and our patients for supporting Saluda in this important study."

1. *Data on file. Individual patient frequency ranges vary.

About the Avalon Study
The Avalon Study is a prospective, multi-center, single-arm study. The study enrolled patients across five clinical sites in Australia. Patients were confirmed to have chronic, intractable pain (visual analogue scale [VAS] ≥6 cm for the past week) that was refractory to conservative therapy for at least 3 months and have had stable prescription pain medication dosage(s) for at least 4 weeks. The protocol is publicly registered at the Australian New Zealand Clinical Trials Registry (ACTRN12615000713594).

CAUTION: Evoke^® is an investigational device in the United States. Evoke is limited by Federal (or United States) law to investigational use. It is not available for sale in the United States.

About Saluda Medical
Saluda Medical is a global neuromodulation company leading the development and commercialization of data-driven, personalized therapies for patients with chronic pain. The company's first product, Evoke^®, is a closed-loop spinal cord stimulation (SCS) system designed to treat chronic pain, a condition that affects more than 540 million people globally. SCS treats the condition by stimulating the spinal cord and altering the transmission of pain signals to the brain. Saluda's proprietary Evoke System is the only closed-loop SCS system designed to provide real-time customization of waveforms to each unique ECAP which can be updated more than 100 times a second, to deliver consistent therapy within a patient's individual therapeutic window. To learn more, visit www.saludamedical.com and connect with us on LinkedIn at www.linkedin.com/company/saluda-medical/.

SOURCE Saluda Medical