Saluda Medical Announces Clinical Study Results for Evoke® ECAP-Controlled, Closed-Loop SCS System for the Treatment of Chronic Pain

New Results Highlight the Importance of Objective Neurophysiological Measures and Clinically Meaningful Functional Outcomes

ARTARMON,Australia,June 3,2019 --Saluda Medical Pty Limited ("Saluda Medical") today announced data from two clinical studies evaluating the performance of the company's Evoke® ECAP-Controlled,Closed-Loop Spinal Cord Stimulation (SCS) System and its impact on pain relief for patients suffering from chronic pain. Evoke is designed to be 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 maintain activation within the patient's therapeutic window.

Results were reported in multiple plenary and oral presentations by leading pain specialists during the International Neuromodulation Society (INS) 14th World Congress in Sydney.

The Evoke and Avalon studies both demonstrated improvements in pain,function,sleep,and quality of life. These data substantiate the observation that considerable pain relief can impact a patient's entire life,including reduction in pain medications.

Steven M. Falowski,M.D.,Director of Functional Neurosurgery at Neurosurgical Associates of Lancaster in Lancaster,PA and an investigator in the Evoke Study,said,"Two separate studies of the Evoke System show promising results. The U.S. Evoke study,the first double-blind randomized regulatory approval study in SCS,demonstrated better rates in pain relief and secondary outcomes for closed-loop compared to control. The Avalon study,an Australian prospective,single-arm study,provides long-term evidence for sustained pain relief with closed-loop. Both studies provide evidence supporting the novel design of the device where ECAPs are measured to monitor therapy delivery in real time. The technology provides an objective measure based on a neurophysiological response to control therapy delivery and provides insight into the mechanism of action. There were a plethora of talks featuring ECAPs at this congress and they highlight the potential clinical utility of this new technology."

Dr. Charles Brooker,Director of the Pain Management and Research Centre,Royal North Shore Hospital and Principal Investigator in the Avalon Study,highlighted,"With Evoke,study results suggest that pain relief continues to improve over time,which is not typically observed with fixed-output systems. With the capability of neurophysiology measurements,such as percentage time in the therapeutic window,we can now start to understand a complex condition objectively in addition to patient reported outcomes,an important advancement to the field of pain management."

Key results presented at the congress from the Evoke U.S. Pivotal Study at 3 months include:

Closed-loop met all pre-specified endpoints.

Closed-loop demonstrated statistically superior back and leg pain relief (with no increase in pain medications) compared to control with more than 80% (82.3% [51/62]) of closed-loop subjects achieving greater than or equal to 50% pain relief (control: 60.3% [38/63]).

More than half of closed-loop subjects (58.1% [36/62]) were high responders with greater than or equal to 80% reduction in back and leg pain (control: 42.9% [27/63]).

Closed-loop maintained spinal cord activation within the therapeutic window 1.5x that of the control group (91.1% of the time with closed-loop vs. 59.5% of the time with control).

Key results presented at the congress from the Avalon Australian Study at 18 months include:

More than 2 out of 3 patients (69.4% [25/36]) experienced more than 80% pain relief.

More than 8 out of 10 patients (83.3% [30/36]) experienced clinically meaningful improvement in quality of life.

Disability was also reduced,with more than 7 out of 10 patients (72.2% [26/36]) having only minimal to moderate disability compared to 18.0% [9/50] at baseline.

More than 2 out of 3 patients (67.9% [19/28]) reduced or eliminated opioid medications.

Spinal cord activation was maintained within the therapeutic window 97.5% of the time.

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 designed to be the first 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 is designed to maintain long-term results through ECAP control.It is currently under investigation through the first double-blinded,randomized,controlled U.S. pivotal study in SCS. Saluda is pursuing CE Mark,TGA approval,and FDA approval of Evoke.

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/.

Note: The Evoke® Spinal Cord Stimulation System is an investigational device in the United States and is limited by U.S. Federal law to investigational use only. These products are not yet approved for marketing or for sale in any geography.

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