| Minneapolis: Saluda Medical, Inc. (ASX: SLD), a commercial-stage medical device company dedicated to advancing therapies for chronic neurological conditions, has announced that its next-generation EVA™ Sensing Technology has received CE certification, enabling commercialization across Europe. The approval has also been formally recognized in Australia, further strengthening the company’s global regulatory footprint. This milestone follows the U.S. Food and Drug Administration’s approval of EVA™ in December 2024, underscoring Saluda Medical’s steady regulatory progress across major healthcare markets. EVA™ Sensing Technology represents the latest evolution of Saluda’s Evoke® System, the world’s first closed-loop spinal cord stimulation (SCS) device capable of sensing and responding to the spinal cord’s evoked compound action potentials (ECAPs) in real time. By continuously measuring neural responses and automatically adjusting stimulation, the technology delivers a highly personalized therapy experience designed to optimize pain relief and improve long-term patient outcomes. Building on the clinical success of the Evoke® System, EVA™ Sensing Technology introduces advanced automation and objective analysis into the therapy delivery process. The platform scans and evaluates a patient’s spinal cord physiology to precisely tailor stimulation parameters, significantly reducing the reliance on manual programming. By eliminating much of the trial-and-error traditionally associated with spinal cord stimulation, EVA™ anchors therapy directly to each patient’s unique neurophysiology, setting a new benchmark for precision and consistency in pain management. Commenting on the approval, Barry Regan, Chief Executive Officer of Saluda Medical, said the regulatory clearance aligns closely with the company’s expectations and reflects the growing momentum behind its closed-loop neuromodulation platform. He noted that the expansion into Europe and Australia builds on strong commercialization progress in the United States and allows Saluda Medical to extend a proven technology enhancement to additional international markets. According to Regan, the milestone reinforces the company’s commitment to driving innovation and improving clinical outcomes for patients living with chronic pain worldwide. Clinical experts have also welcomed the approval. Dr. Harold Nijhuis, Pain Specialist at Antonius Hospital in the Netherlands, highlighted that EVA™ Sensing Technology builds on the positive clinical outcomes already demonstrated by the Evoke® System when compared with conventional open-loop spinal cord stimulation. He emphasized that the technology delivers objective neural metrics aligned with optimal analgesic benefit, while simultaneously streamlining clinical workflows and enhancing the overall patient experience. Saluda Medical plans to initiate a limited commercial release of EVA™ Sensing Technology in Europe and Australia during the first quarter of calendar year 2026, followed by a broader commercial rollout later in the year. The timing of both approval and launch is consistent with the company’s internal development and commercialization roadmap. The Evoke® System, Saluda Medical’s flagship product, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, intractable low back pain, and chronic leg pain. Its clinical credibility is supported by robust evidence from the landmark EVOKE Study, the first and only prospective, multicenter, randomized, double-blind pivotal trial in spinal cord stimulation. Results demonstrating superior and sustained pain relief have been published in leading peer-reviewed journals, including The Lancet Neurology, JAMA Neurology, and Regional Anesthesia and Pain Medicine. With the CE certification of EVA™ Sensing Technology, Saluda Medical strengthens its position at the forefront of closed-loop neuromodulation, advancing its mission to redefine the standard of care for chronic pain through data-driven, patient-specific therapy. |
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