Saluda Medical Surpasses Milestone: Measuring One Trillionth ECAP From Patients with the Evoke® System

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Oct 25, 2022, 09:00 ET

The Evoke^® System is the First to Measure, Record, and Proactively Customize Spinal Cord Stimulation for Patients

ARTARMON, Australia, Oct. 25, 2022 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation, today announced it has recorded and measured over one trillion Evoked Compound Action Potentials (ECAPs) with the Evoke^® Spinal Cord Stimulation (SCS) System, representing a milestone in the company's mission to use big data to deliver transformational therapies to the global SCS market. Saluda's Evoke^® System is the only approved therapy capable of automatically adjusting real time to the neurophysiologic changes each patient undergoes throughout the day. The Evoke^® System, powered by the groundbreaking SmartLoop^™ technology, has demonstrated long-term, sustained pain relief as well as improvements in patients' quality of life, functional status, mood, and sleep in the only double-blinded randomized controlled study in the SCS space with 24-month follow up data.

Data and insights captured to date stand to accelerate the fundamental understanding of chronic pain and further enhance Evoke^® SCS System performance. These insights will also inform the development of new platforms designed to deliver consistent, durable, and optimized therapy.

The neural activation of the spinal cord has been extremely difficult to measure. The evoked compound action potential (ECAP) from nerves is 100 times smaller than the heart's electrical signal (called the electrocardiogram or EKG) and typically travels faster than 50 meters per second. Saluda Medical spent more than ten years perfecting the precise measurement and recording of ECAPs to maintain the prescribed level of therapeutic neural activation.

"One trillion ECAPs is an impressive milestone as it represents the enormity of this growing databank of observations which demonstrate how Evoke^® therapy interacts with the spinal cord and will be pivotal in deriving empirical evidence to advance the field. For perspective, this achievement is analogous to assembling all the base pairs of the human genome," said Marc Russo, MD, Associate Professor, Director of Hunter Pain Specialists and President of the International Neuromodulation Society (INS).

"As an interventional pain physician and neurophysiologist who has worked with Saluda for the past decade and was involved in the early clinical feasibility work to measure and control ECAPs, this milestone means a lot now, but will mean even more in the future. Therapy optimization using strong additional objective and measurable data, and not only subjective patient assessment, is what we researched for the last 40 years and finally such wealth of real-time electrophysiological data can be reliably used to optimize spinal cord stimulation therapy," said Leonardo Kapural, MD, PhD, Carolinas Pain Institute.

About Saluda Medical

Saluda Medical is a global company transforming patients' lives with disruptive neural sensing technologies designed to revolutionize the field of neuromodulation. The company's first product, the Evoke^® System, is the only smart spinal cord stimulation (SCS) system and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The Evoke^® System instantaneously reads, records, and responds to each patient's neural signature to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology and 24-month results have since been published in JAMA Neurology. Both publications are poised to set new clinical standards for long-term pain relief and improvements in physical and emotional functioning, sleep quality and health-related quality of life. Furthermore, there is promising data to show the Evoke^® System demonstrated a reduction in re-programming visits over time as well as an elimination of explants due to loss of efficacy out to 24-months – which are significant challenges with current SCS therapies. To learn more, including risks & important safety information, visit www.saludamedical.com.

Saluda Medical and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.

Media Contact:

Stella Kim
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Investor Contact:

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Gilmartin Group
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SOURCE Saluda Medical