FUSMobile recently announced its first commercial patient treatment in the US. Using the Neurolyser XR system, the low back pain treatment was performed by Leonardo Kapural, MD, PhD, at the Carolinas Pain Institute (CPI) in Winston-Salem, North Carolina. While the CPI is the first site in the US offering the treatment outside of a clinical trial, others are in the process of being added.
The Neurolyser XR is a first-of-its-kind device. Guided by x-ray fluoroscopy imaging, it applies high-intensity focused ultrasound to heat and destroy sensory nerves in the spinal facet joints. These nerves are a leading source of chronic low back pain, which affects millions of adults. Clinical data suggested that this noninvasive approach reduced patient discomfort and post-procedure pain compared with traditional interventional methods, such as steroid injections and radiofrequency denervation.
The device was granted De Novo clearance by the US Food and Drug Administration (FDA) for the treatment of chronic low back pain in November 2025. This means the FDA has authorized the device as safe and effective, established it as a new category of treatment, and cleared it for marketing in the US. The Neurolyser XR also has also been granted the CE Mark in the European Union, Health Canada approval, and is registered in the UK.
In the company’s press release, Arik Hananel, MD, MBA, co-founder of FUSMobile, added, “The adoption of focused ultrasound is accelerating globally, and we believe it is poised to become the new standard of care across multiple clinical areas.”
