Jul 18, 2024

News provided by Share this article Share toX ASPN Top Abstract awarded for analysis demonstrating benefits associated with the Evoke® System's utilization of objective measurements to achieve maximum analgesic effect for SCS Separate analysis suggests 98% positive predictive value of long-term SCS therapy success on day zero of trial period MINNEAPOLIS, July 18, 2024 /PRNewswire/ -- Saluda Medical, Inc., a commercial-stage medical device company focused on developing treatments for chronic neurological conditions driven by a novel closed-loop, dose-control neuromodulation platform, today announced the recent presentations of two abstracts analyzing biomarker-based spinal cord stimulation (SCS) data at the American Society of Pain and Neuroscience (ASPN) 2024 Annual Conference, held July 11-14, 2024, in Miami, FL. The abstracts, which were among 10 total abstracts with Saluda Medical clinical data presented at ASPN, relied on evidence from patients treated with the Evoke System in clinical studies. Key takeaways from these two abstracts demonstrate the significance of objective neurophysiological measurements in SCS with evoked compound action potential (ECAP) dose-controlled closed-loop therapy. Key Abstracts Presented: "Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements with ECAP Dose-Controlled Closed-Loop SCS": Authored by Dr. Robert Levy, MD, PhD, and based on a paper accepted for recent publication in the journal Neuromodulation, this abstract was awarded "Top Abstract" out of more than 300 clinical abstracts, and was also featured as an oral presentation; the abstract sought to characterize the biomarker-based dose-response relationship that produced a patient's maximal analgesic effect. The analysis showed a statistically significant relationship between usage over ECAP threshold, ECAP dose and pain relief across the patient population. In addition, the analysis demonstrated that the clinical benefit observed in the trial period was reproduced following permanent implantation when the neurophysiological metrics remained consistent. "Identifying SCS Trial Responders Immediately after Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy": Authored by Dr. Jason Pope, MD and based on the recent published paper by Pope, Antony, Petersen, et al., this abstract was also featured in an oral presentation; the abstract sought to analyze the benefits of closed-loop, dose-control SCS as it relates to trial outcomes and the predictability of long-term success. The analysis compared neurophysiological and certain patient reported metrics between the day of the trial procedure, or day 0, and the end of the trial. Success criteria included confirmation of neural activation and dose-controlled closed-loop therapy, patient reported pain relief, functional improvement and willingness to proceed. The analysis measured patients who passed all success criteria on day 0 and demonstrated that these success criteria had a 98% positive predictive value for being responsive to therapy at the end of the trial period. "Saluda's scientific presence at this year's ASPN conference is reflective of our commitment to elevate SCS therapy with best-in-class clinical evidence grounded in real world data and our double-blinded EVOKE RCT, and we sincerely thank our clinical investigators and their patients," said Jim Schuermann, President and CEO of Saluda Medical. "These two abstracts, highlighting biomarker-based measurements, in particular are significant to the field of SCS. We believe that the Evoke System's ability to objectively measure and respond to these neurophysiological metrics allows it to improve the reliability and reproducibility of patient outcomes from the trial period through the long-term follow-up." About Saluda Medical Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions driven by a novel neuromodulation platform. The Company's closed-loop, dose-control platform is designed to sense and measure neural responses to stimulation and automatically adjust therapy based on real-time neurophysiological feedback. The Company's first product, the Evoke® System, 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, and is designed to treat chronic neuropathic pain and can sense and measure neural activation to optimize and adjust therapy in real time with every stimulation pulse, up to 250 times per second. 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, 24-month results have been published in JAMA Neurology, and unprecedented 36-month data, demonstrating enduring and consistent pain relief results were published in Regional Anesthesia and Pain Medicine. To learn more, including risks & important safety information, visit  www.saludamedical.com/us/safety/ . 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