FUS Mobile has developed the Neurolyser platform as the only non-invasive treatment system optimized to destroy neural tissue associated with chronic low back pain (facet arthritis) and other conditions such as knee and hip arthritis.
The Neurolyser XR uses X-ray guidance to direct multiple high intensity focused ultrasound beams of energy from outside the body to a focal point. Once the acoustic energy beams converge at the target area, they generate localized heat to ablate the neural tissue, leaving skin and other tissue along the pathway intact.
The Neurolyser’s guidance platform is very intuitive, combining radiological and optical targeting, using image processing to speed up targeting and reduce radiation exposure.
A 10-patient Canadian pilot study evaluating the Neurolyser XR achieved an excellent safety profile and promising initial effectiveness for the treatment of low back pain resulting from facet arthritis. The results of this study will be submitted for publication soon.
FUSMobile will begin a pivotal trial for North American regulatory approvals in 2020. This prospective single arm open-label study will recruit patients with chronic facet joint pain to be treated with the Neurolyser XR at multiple centers in the US and Canada.
The Neurolyser XR System
 Control Unit
 Ultrasonic Transducer
 Positioner and Aiming Apparatus
 Imaging Workstation
Neurolyser XR connects to the same X-ray equipment commonly used in pain clinics. The Imaging Workstation superimposes treatment related overlays onto acquired x-ray images. Acoustic coupling between the device and the patient’s back is achieved with a disposable gel pad placed between the transducer and the patient’s back.
A Better Solution
The Neurolyser was developed to be a completely non-invasive treatment approach that is comfortable for the patient, with minimal pain during the procedure. The proposed investigational use for the technology is designed to eliminate the risk of infection or bleeding associated with more invasive procedures such as radiofrequency (RF) ablation, which is the current standard treatment. The Neurolyser may create larger lesions that potentially can increase treatment success rates and durability.
Investigational Use Only