Saluda Medical Announces Presentation of New Clinical Data at the 2025 NANS Annual Meeting
Presentations Included First Human Data on EVA™, Saluda's Automated SCS Programming Platform
MINNEAPOLIS, Feb. 5, 2025 /PRNewswire/ -- Saluda Medical, Inc., a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, today announced the presentation of new clinical data at the 2025 North American Neuromodulation Society (NANS) Annual Meeting, held from January 30 – February 1, 2025, in Orlando, FL.
Data from 11 total abstracts and four oral presentations, two of which received the 'Top Oral Abstract' award, underscore the significance of objective neurophysiological measurements in spinal cord stimulation (SCS) with evoked compound action potential (ECAP) dose-controlled closed-loop therapy, and the potential clinical benefits of Saluda Medical's recently FDA-approved automated patient programming platform, EVA™.
Highlights from EVA™ Automated Programming Abstract:
'Novel Automated Platform to Upgrade SCS Programming Experience from Subjective to Objective: Results from a Prospective, Dose-Controlled Closed-loop Clinical Study,' by Ajay Anthony, MD:
94% of all programming sessions using the automated programming platform successfully generated a closed-loop program
<13-minute median time to generate each patient-specific automated program
≥90% of patients were satisfied or very satisfied with the automated programming platform experience
Highlights from 'Top Oral Abstracts":
'ECAP Study Premiere: Real-World IDE Study Showing Relationship between Physiologic ECAP Biomarkers and Pain Outcomes,' by Jason Pope, MD:
The ECAP IDE Study builds on the EVOKE IDE Study and represents the largest SCS study executed in a real-world cohort of 220 patients
Real-world data demonstrated profound improvement (≥2 MCIDs) across all pain subgroups in the study including pain associated with Failed Back Surgery Syndrome, Non-Surgical Back Pain, Complex Regional Pain Syndrome, Diabetic Peripheral Neuropathy, and Upper Limb Pain
'Characterizing Spinal Cord Neurophysiology Using ECAP Dose-Controlled Closed-Loop SCS,' by Harold Nijhuis, MD:
First SCS study to objectively characterize differences in cervical and thoracic spinal neurophysiology
Significantly higher cervical SCS sensitivity may increase the risk of over- and under-stimulation when using open-loop SCS
Precise dosing on a pulse-pulse basis using an ECAP dose-controlled closed-loop SCS may be necessary for durable long-term outcomes in the cervical spine
'Saluda is driving a pivotal moment in SCS, where advanced neurophysiological data and automation are redefining the standard of care,' said Jim Schuermann, President and CEO of Saluda Medical. 'We believe the next generation of SCS is here, and it's built on the foundation of objective science, precision, and personalized therapy that will continue to elevate patient care for years to come.'
'What stands out to me about these results is the newfound clarity in understanding the relationship between ECAP biomarkers and pain outcomes,' said Dr. Jason Pope, MD, Founder and CEO of Evolve Restorative Center. 'This real-world data from the largest SCS IDE study gives us confidence that tailored therapy with the Evoke System can significantly improve pain relief across multiple patient etiologies we treat in our practices. This kind of personalized, biomarker-driven therapy is leading to other breakthroughs such as predicting responders and non-responders to therapy and automation of programming to achieve the best relief for our patients.'
The recognition of the Evoke® System at the 2025 NANS Annual Meeting highlights Saluda's commitment to advancing the field of neuromodulation through cutting-edge science and innovation. By combining real-world clinical evidence, objective biomarkers, and automation. Saluda is empowering clinicians to deliver more precise, personalized, and effective therapies for patients with chronic pain. These achievements underscore Saluda Medical's leadership in redefining SCS and its unwavering dedication to improving the lives of millions of patients.
About Saluda Medical
Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel neuromodulation platform. The Company's closed-loop, dose-control platform senses and measures neural responses to stimulation and automatically adjusts 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 by providing spinal cord stimulation (SCS) therapy that senses and measures neural activation to optimize therapy and reduce patient and clinician burden. 12-month results from the EVOKE study, the first and only prospective, multi-center, parallel-arm, double-blind, randomized controlled pivotal study with a voluntary crossover arm in SCS, that demonstrated clinically superior pain relief to open-loop therapy, were published in The Lancet Neurology, 24-month results were published in JAMA Neurology, and 36-month data, that demonstrated sustained pain relief, were published in Regional Anesthesia and Pain Medicine. To learn more, including risks and important safety information, visit www.saludamedical.com/us/safety/.
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