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Subject: TRI

Saluda Medical Reports Final Long-Term Results out to 24 Months from Avalon Study and Results at 12 Months from U.S. Evoke Pivotal Study


Key Findings Highlighted in Multiple Presentations, Including Best Clinical Abstract, at NANS 2020

HARROGATE, England, Jan. 27, 2020 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical") today announced that new data, from multiple studies evaluating the company's Evoke® ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System for the treatment of chronic pain, were presented in a series of oral and poster presentations, including Best Clinical Abstract, during the North American Neuromodulation Society (NANS) 23rd Annual Meeting, held January 23-26, 2020 in Las Vegas, Nevada, United States.

The data included final results out to 24 months from the Australian Avalon study and results at 12 months from the U.S. Evoke Pivotal Study.

John Parker, CEO of Saluda Medical, commented, "As we expand commercialization in Europe, we believe the collective results from these studies, along with the aggregate real-world experience in the first European centers, provide substantial evidence that supports the advantage of the Evoke therapy.  As the first and only ECAP-controlled, closed-loop SCS system, Evoke enables the ability to objectively define the therapeutic window for each patient, which leads to greater levels of spinal cord activation and more time within this therapeutic window over the long term, enabling patients to achieve better pain relief, including secondary outcomes such as improved sleep quality, reduced disability, and reduced opioid use. We believe these results substantially advance the field of neuromodulation."

Oral Presentations

Avalon Study: Long-Term Impact of ECAP-Controlled Closed-Loop SCS on Pain, Patient Wellbeing and Clinical Practice

ECAP-Controlled Closed-Loop SCS:  Double-Blind, Randomized Trial for the Treatment of Chronic Pain: 12-month Outcomes

"High Responders" to Neurostimulation Show Greater Clinical & Overall Meaningful Response in Patient Reported Outcomes

Long-Term Robustness of Evoked Compound Action Potentials (ECAPs) as a Physiological Monitoring Tool

Therapeutic Levels and Variability of Spinal Cord Activation: Closed-Loop v. Open-Loop Spinal Cord Stimulation (SCS)

Defining the Therapeutic Window for Spinal Cord Stimulation using Evoked Compound Action Potential (ECAP) Recordings

Sleep Quality Improvements Observed in the Evoke Study of ECAP Measurement and ECAP-Controlled Closed-Loop SCS

Poster Presentations

Understanding the Effect of Titrating Medication with SCS Using Evoked Compound Action Potentials (ECAPs)

Evoked Compound Action Potentials (ECAPs): Helping to understand Spinal Cord Stimulation (SCS)

About Saluda Medical

Saluda Medical is a global medical device company focused on patient outcomes, science, and engineering to transform the neuromodulation industry with a platform of closed-loop technologies based on the evoked compound action potential (ECAP). Saluda's first device, Evoke®, is the first ECAP-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) System. Evoke measures the spinal cord's response to stimulation (ECAP), adjusts on every pulse to optimize activation within the patient's therapeutic window, and maintains long-term results through ECAP control as demonstrated in the Avalon Study and Evoke Study. In the EU, Evoke is CE Marked and commercially available. In the U.S., Evoke is currently under investigation through the first double-blinded, randomized, controlled U.S. pivotal study in SCS and is not commercially available.

Saluda Medical is a privately-held company with headquarters in Artarmon, New South Wales, Australia and offices in Bloomington, MN, USA and Harrogate, UK. To learn more, visit www.saludamedical.com and connect with us on LinkedIn at www.linkedin.com/company/saluda-medical/.

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