Key Points
- FUSMobile has announced that its Neurolyser XR system has been granted clearance by the US Food and Drug Administration (FDA) for the treatment of chronic low back pain.
- The device, which uses focused ultrasound to ablate sensory nerves in the spinal facet joints, is also approved in Europe, Canada, and the UK.
FUSMobile has announced that its Neurolyser XR system has been granted De Novo clearance by the US Food and Drug Administration (FDA) for the treatment of chronic low back pain. 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 United States.
The Neurolyser XR is a first-of-its-kind device that uses high-intensity focused ultrasound guided by x-ray fluoroscopy imaging to heat and destroy sensory nerves in the spinal facet joints. These nerves are a leading source of chronic low back pain affecting millions of adults. Clinical data suggest this noninvasive approach could reduce patient discomfort and post-procedure pain compared with traditional interventional methods, such as steroid injections and radiofrequency denervation.
The FDA’s ruling was based on data from the company’s pivotal clinical trial for lumbar zygapophyseal joint syndrome, which took place at 10 sites in the US. These data will be published in the coming months, but similar studies were conducted in Canada and Israel.
The Neurolyser XR device also has the CE Mark in the European Union, Health Canada approval, and is registered in the UK.
“The FDA’s clearance of the Neurolyser XR represents an important milestone for the field of focused ultrasound,” said Focused Ultrasound Foundation Chairman Neal F. Kassell, MD. “This therapy can deliver better outcomes for patients by providing a safe, highly effective, and cost-effective alternative to existing treatments to countless patients suffering from chronic low back pain.”
According to FUSMobile co-founders Arik Hananel, MD, and Ron Aginsky, “The adoption of focused ultrasound is accelerating globally, and we believe the Neurolyser XR device is poised to become the new standard of care across multiple clinical areas. We take pride in our regulatory approvals and continue to work diligently to advance the Neurolyser platform in other markets while seeking additional clinical indications.”
Looking ahead, the company also has an ongoing clinical trial for the treatment of sacroiliac joint pain and will test the device on patients with chronic knee pain due to osteoarthritis. FUSMobile also plans to explore additional indications in the near future.
The FUSMobile website lists four current treatment centers in Canada, Italy, and Spain.
Dr. Hananel is the former Scientific and Medical Director at the Focused Ultrasound Foundation. He founded FUSMobile in 2014 with Mr. Aginsky to develop noninvasive, high-precision therapies for the treatment of chronic pain.