Key Points
- FUSMobile’s Neurolyser XR device has been approved by Health Canada for the treatment of chronic low back pain facet arthritis.
- The device was also granted the European CE Mark in May.
FUSMobile’s Neurolyser XR device has been approved by Health Canada for the treatment of chronic low back pain facet arthritis (or lumbar zygapophyseal joint 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 has published data showing that its noninvasive approach reduces patient discomfort and post-procedure pain compared with traditional interventional methods, such as steroid injections and radiofrequency denervation.
Health Canada is the regulatory body in Canada and is part of the federal government. The ruling was made in part based on data from a 30-participant multicenter clinical trial that took place in Toronto. The trial’s promising results, published in Regional Anesthesia & Pain Medicine, 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 safety and efficacy.
“The FUSMobile team is excited to expand collaboration with the Canadian healthcare community with the goal of fighting chronic pain,” said Arik Hananel, MD, the company’s CEO, co-founder, and co-chairman of the Board of Directors.
“The Neurolyser XR introduces a unique solution that benefits all healthcare stakeholders,” said Ron Aginsky, the company’s president, co-founder, and co-chairman of the Board of Directors. “It provides to patients a noninvasive procedure with quicker pain relief and potentially better throughput for providers.”
This announcement comes on the heels of another regulatory win. In May 2024, the Neurolyser XR was granted the CE Mark in Europe.