Key Points
- FUSMobile’s Neurolyser XR device has been granted the CE Mark for the treatment of a common cause of chronic low back pain.
- The device is the first focused ultrasound system using x-ray guidance specifically for treating pain indications.
FUSMobile has announced that its Neurolyser XR device has been granted CE Mark for the treatment of lumbar zygapophyseal joints syndrome, a common cause of chronic low back pain.
The Neurolyser XR uses high-intensity focused ultrasound (HIFU) guided by x-ray fluoroscopy imaging to heat and destroy neural tissue. The company claims the noninvasive approach reduces patient discomfort and post-procedure pain compared with traditional interventional methods, such as steroid injections and radiofrequency denervation.
The CE Mark is a regulatory symbol that indicates a product meets the European Union’s health and safety requirements. The ruling was made in part based on data from a 30-participant multicenter clinical trial that took place in Toronto, Canada. The trial’s promising results indicated that 82.6% of participants responded to the treatment at 180 days post-procedure. Importantly, no device-related side effects were reported. This larger trial confirmed early clinical data published in 2021 that showed similar efficacy.
“This CE mark approval is a significant milestone for FUSMobile,” said Ron Aginsky, president, co-founder, and co-chairman of the Board of Directors at FUSMobile. “We are the first company to commercialize an x-ray–guided HIFU system specifically for treating pain indications. This approval reinforces our commitment to providing innovative, noninvasive solutions to improve patient outcomes.”
Arik Hananel, CEO, co-founder, and co-chairman of the Board of Directors at FUSMobile, added, “We are dedicated to expanding our premium platform to offer better alternatives for pain relief, enhancing the patient experience both during and after treatment.”
The company plans to introduce the Neurolyser XR device in luminary pain management sites in Western Europe.