CMS Grants Transitional Pass-Through (TPT) Payment for Saluda's Evoke® SCS System

New device category in SCS enables increased reimbursement, effective January 1, 2023

ARTARMON, Australia, Nov. 7, 2022 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation, announced the Centers for Medicare & Medicaid Services (CMS) has granted approval for a transitional pass-through (TPT) payment for the Evoke^® SmartSCS™ System, under the Medicare hospital outpatient prospective payment system. "The Evoke^® SCS System represents a substantial clinical improvement over existing technologies based on the data received from commenters", according to CY2023 OPPS/ASC Final Rule. The Department of Health and Human Services (HHS)-approved document also states, "We believe this RCT (EVOKE Study) comparison served to demonstrate substantial clinical improvement provided by the closed-loop system, differentiating it from open-loop systems typically described by existing device categories, thus supporting the creation of a new device category". The TPT payment, which will be effective for three years beginning January 1, 2023, is a mechanism created by CMS to increase patient access to new and innovative technology while allowing hospitals and Ambulatory Surgery Centers (ASCs) to receive additional payment for the use of new technology.

The TPT payment for the Evoke System will provide incremental Medicare reimbursement to providers beyond the established payment for the implantation of spinal cord stimulation devices. CMS determined that the Evoke System met the TPT criteria based on the published EVOKE Study, the only double-blinded randomized control trial (RCT) in the spinal cord stimulation space. The new code, C1826 describing this new pass-through device category, will be published in January 2023. Details on the TPT can be found in the CY2023 OPPS/ASC Final Rule, accessible on the CMS website: https://www.cms.gov/files/document/cy2023-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-final-rule.pdf

"The TPT for Evoke is significant because for the first time, clinicians can directly measure the spinal cord's physiologic response to stimulation through Evoked Compound Action Potentials (ECAPs). It is currently the only SCS system that can measure ECAPs and automatically adjust stimulation in real time, over 4+ million times per day, providing a precise stimulation dose based on the patient's unique neural signature. This provides consistent and accurate neural activation which is what delivers lasting pain relief as seen in the EVOKE Study. No other SCS device can demonstrate consistent, accurate and enduring neural activation," said Corey Hunter, MD, FIPP, Assistant Clinical Professor, Mt. Sinai Hospital, New York and Principal Investigator of the EVOKE Study.

The Evoke System received FDA approval earlier this year based on the landmark EVOKE Study which showed closed loop superiority over open-loop SCS in treating overall back and leg pain. The Evoke System has been proven to provide consistent neural activation and long-term, sustained outcomes for both pain relief and holistic outcomes including improvements in quality of life, functional status, mood, and sleep with zero explants due to loss of efficacy in closed-loop patients at 24 months. Three-year follow-up data from the EVOKE Study is expected to be released at NANS 2023.

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 ECAP-controlled closed-loop 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 automatically  reads, records, and responds to the nerves' response to stimulation 4+million times a day 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/us/safety/.

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

Media Contact:

Stella Kim
+1 (651) 270-3084
[email protected]

Investor Contact:

Brian Johnston
Gilmartin Group
(332) 895-3222
[email protected]

SOURCE Saluda Medical