Saluda Medical

United States · Medical Devices

Saluda Medical is a global company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders. The company's first product, the Evoke® System, is the only ECAP-controlled closed-loop 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 the nerves' response to stimulation 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 JAMA Neurology. Both studies 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. In the EU, Evoke is CE Marked and commercially available. In the U.S., Evoke is FDA-approved and will be available when the Company implements its full commercial release in 2023. Saluda Medical is a privately held company with headquarters in Artarmon, New South Wales, Australia and has offices in Bloomington, MN, USA; Harrogate, UK; and Terheijden, Netherlands. To learn more about Saluda Medical, including the risks & important safety information, visit www.saludamedical.com.