NaviFUS Reports Breakthrough in U.S. Epilepsy Trial, Strengthens Global Footprint
(Taipei, August 20, 2025) — NaviFUS Corps. (6872) announced that the U.S. clinical trial of its NaviFUS® focused ultrasound system for drug-resistant epilepsy (DRE), led by Stanford University (trial link: https://clinicaltrials.gov/study/NCT06388707?term=FUS%20navifus&rank=4#more-information ), successfully completed treatment of its first patient at the middle of Aug. The trial is expected to finish enrollment of all six participants in the first half of next year.
The study is conducted across three leading U.S. medical centers: Stanford University School of Medicine, home to a world-renowned epilepsy center with decades of expertise in drug-resistant epilepsy and neuromodulation; Brigham and Women’s Hospital, recognized as a pioneer in focused ultrasound research; and the University of Virginia Health System, known for its deep capabilities in neuroscience and clinical epilepsy research. This multicenter collaboration greatly enhances the trial’s clinical value and international impact, aiming to deliver a safer, non-invasive therapeutic option for patients who have limited alternatives beyond medication.
NaviFUS® uses focused ultrasound technology to non-invasively target specific brain regions, making long-term treatment feasible without the need for surgery. Compared to conventional surgical treatments like deep brain stimulation (DBS) and vagus nerve stimulation (VNS), which require implanting devices, NaviFUS® is expected to have fewer side effects and offers greater flexibility to adjust treatment locations and parameters based on each patient’s condition—potentially improving both patient acceptance and quality of life.
According to Market Research Future (MRFR), the global epilepsy treatment market is projected to grow from approximately USD 9 billion in 2023 to over USD 13 billion by 2030, at a compound annual growth rate (CAGR) of about 5%. This highlights strong market demand for innovative, non-invasive therapies and significant opportunities for focused ultrasound technologies.
In addition to the U.S. trial, NaviFUS Corps. has launched a new Phase II trial in Taiwan (trial link: https://clinicaltrials.gov/study/NCT06492720?term=FUS%20navifus&rank=3 ), which is steadily enrolling patients, and an Australian trial (trial link: https://clinicaltrials.gov/study/NCT05947656?term=FUS%20navifus&rank=7 ) that is expected to reach its first-stage enrollment target by the end of this year. All three trials are anticipated to generate preliminary clinical data next year, which will help guide optimal treatment frequency and targeting strategies for future pivotal studies, further supporting the global clinical adoption and expansion of the NaviFUS® platform.