Saluda Medical Achieves Regulatory Milestone with EVA™ Technology
Saluda Medical, Inc. (ASX:SLD) has made significant strides in the medical device industry by achieving CE certification for its next-generation EVA™ Sensing Technology. This advancement not only marks a major endorsement in Europe but also is recognized in Australia. Following FDA approval in December 2024, this certification showcases Saluda's commitment to enhancing treatment options for chronic neurological conditions.
Understanding EVA™ Sensing Technology
The EVA Sensing Technology builds upon the innovative Evoke® System, known for being the first closed-loop spinal cord stimulation device capable of interpreting and responding to the spinal cord's evoked compound action potentials, or ECAPs. This capability heralds a new era of truly personalized therapy, designed to ensure the best possible patient outcomes.
Automation and Precision in Pain Management
This technology centers around automating manual programming steps, which significantly enhances the precision of therapy delivery. By objectively examining a patient’s spinal cord responses, EVA Sensing Technology effectively removes much of the guesswork traditionally associated with spinal cord stimulation, ensuring that treatment is tailored specifically to each patient's unique physiology.
Leadership Voices on the Approval
Barry Regan, the CEO of Saluda Medical, stated, "This approval is in line with our expectations and builds on the successful commercialization we've seen in the U.S. This expansion allows us to bring a proven technology enhancement to more markets, reinforcing our commitment to driving innovation and improving outcomes for patients worldwide."
Expert Testimonials on EVA™ Technology
Healthcare professionals are excited about the implications of EVA Sensing Technology in pain management. Dr. Harold Nijhuis, a Pain Specialist at Antonius Hospital in the Netherlands, noted, "EVA Sensing Technology not only aligns objective neural metrics with maximum analgesic benefit but also simplifies programming, thereby improving efficiency and enhancing the overall patient experience." This reflects a growing acknowledgment of the technology's potential to transform patient care.
Commercial Release Plans
Beginning in the first quarter of 2026, Saluda will initiate a limited commercial release of the EVA Sensing Technology in both Europe and Australia. This will be followed by a full commercial rollout later in the year, aligning perfectly with the company's internal timelines and strategic goals.
About Saluda Medical
Saluda Medical is a pioneering medical device company focused on creating innovative treatments for chronic neurological disorders. Their groundbreaking neuromodulation platform is designed to measure and respond to neural activity, enabling customized therapy adjustments based on real-time feedback.
The flagship product, Evoke® System, is designed to help manage chronic intractable pain associated with conditions like failed back surgery syndrome and neuropathic pain. This system aims to provide superior pain relief, as evidenced by impressive results from various studies published in reputable medical journals.
Contact Information
For more insight and information on Saluda Medical's initiatives and technology, interested parties can contact:
James Erickson, CFO
Saluda Medical
Phone: +61 (0) 427 630 152
Media Inquiries:
Sam Wells, NWR Communications
Phone: +61 (0) 451 896 420
Frequently Asked Questions
What is the EVA™ Sensing Technology?
The EVA™ Sensing Technology is a novel closed-loop system developed by Saluda Medical that monitors and responds to spinal cord signals in real time for personalized therapy.
When will the commercial release of EVA™ in Europe occur?
A limited commercial release is set to begin in the first calendar quarter of 2026, followed by a full launch later in the year.
How does EVA™ Sensing Technology improve patient outcomes?
This technology automates therapy adjustments, providing precise treatment that is tailored to the individual patient's spinal cord physiology, thus enhancing pain management.
Who is Saluda Medical?
Saluda Medical is a commercial-stage medical device firm focused on innovative treatments for chronic neurological conditions through advanced neuromodulation platforms.
What sets Saluda's Evoke® System apart?
The Evoke® System is the first SCS device that can adapt therapy based on real-time feedback from the spinal cord, ensuring superior pain management compared to traditional systems.
