Technology
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.
Indications for Use
The Neurolyser XR is indicated for the thermal ablation of neural tissue to relieve pain from lumbar facet joint arthritis. It is suitable to be used by interventional pain management physicians trained in the equivalent RFA procedure and familiar with its clinical applications and associated risks.
The Neurolyser XR is approved in Europe for neurotomy of the lumbar medial branch nerve as a treatment for facet arthritis low back pain.
Previous clinical studies and publications:
The Neurolyser XR have been through multiple clinical trials, details of which can we found in the ClinicalTrials.gov website.
Peer reviewed publications of the pre-clinical and clinical studies are available here
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.
Multiple studies evaluating the Neurolyser XR demonstrated an excellent safety profile and effectiveness for the treatment of low back pain resulting from facet arthritis.
The Neurolyser XR is approved for clinical use in Europe, UK and Canada .
The Neurolyser XR is not approved in the USA.
Targeted Treatment Through Sound
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.
This investigational technology has the potential to save resources over current standard of care
A Better Solution