Genovate and NaviFUS Report Positive Safety Data from Australian Pilot Study in Drug-Resistant Epilepsy
Genovate Biotechnology Co., Ltd. and its affiliate NaviFUS Corporation announced that the first cohort of an investigator-initiated pre-market pilot study at Alfred Hospital in Australia has completed treatment using the NaviFUS neuronavigation-guided focused ultrasound system in patients with drug-resistant epilepsy (DRE).
An independent Safety Monitoring Committee (SMC) reviewed the data and confirmed that no major safety concerns or serious adverse events were observed in this first cohort. The SMC unanimously recommended proceeding to the second cohort as planned, with an increased number of treatment sessions. In cohort one, patients received four treatments over two weeks; in cohort two, patients will receive six treatments over three weeks. The only difference between the cohorts is the total number of sessions.
This pilot study is designed to evaluate the safety and preliminary efficacy of repeated NaviFUS neuromodulation in DRE patients whose seizures are not adequately controlled by anti-seizure medications. The NaviFUS system is a non-invasive technology that uses focused ultrasound to target the hippocampal region of interest (ROI) in the brain and modulate abnormal activity without open surgery or MRI guidance during each treatment.
All six participants in the first cohort completed all planned treatments. Five have already finished the three-month follow-up visits, and the last participant is expected to complete follow-up by the end of November. The SMC’s assessment considered adverse events, neurological and clinical examinations, cognitive and language testing, and brain MRI findings. Overall, the committee concluded that the NaviFUS system shows a favorable safety profile at this stage of the trial. The Alfred Hospital ethics committee has formally endorsed the SMC’s recommendation.
Preliminary efficacy signals are also encouraging. At the two-month follow-up visit, five of the six participants showed reductions in seizure days and seizure frequency compared with baseline, and two patients experienced reductions of more than 80%. The study will now move to the second cohort to assess whether more treatment sessions can further enhance and sustain clinical benefit, improve patients’ quality of life, and reduce caregiver burden.
Epilepsy is one of the most common neurological disorders worldwide. According to 2024 World Health Organization data, around 50 million people are living with epilepsy, and about 30% have seizures that are not adequately controlled by medication and are classified as having DRE. Surgical resection of the epileptic focus can be effective, but due to lesion location and other clinical limitations, only about 5–10% of patients are suitable candidates. As a result, roughly 10–12.5 million patients have very limited treatment options, highlighting a significant unmet medical need.
Neuromodulation has become an important strategy for treating DRE, including invasive approaches such as deep brain stimulation (DBS), responsive neurostimulation (RNS), and vagus nerve stimulation (VNS). However, these procedures involve implantation and carry risks such as infection, hemorrhage, radiation exposure, and potential tissue damage. To date, no non-invasive neuromodulation medical device has been formally approved specifically for epilepsy treatment.
As a non-invasive, outpatient procedure that does not require MRI guidance during each session, the NaviFUS system aims to offer an attractive treatment option. By using focused ultrasound to modulate abnormal brain activity with high spatial precision and repeatability, NaviFUS combines safety, convenience, and accuracy, and has the potential to provide a safer alternative to traditional brain surgery and implant-based neuromodulation in epilepsy.
Dr. Cheng Chen, Chairman of Genovate Biotechnology and NaviFUS Corporation, noted that the Australian trial—from concept and protocol design, to selection of the principal investigator and CRO, regulatory submissions, and operational coordination—has been jointly executed by Genovate’s clinical team and NaviFUS engineers. He stated that the positive SMC review is an important clinical milestone for the NaviFUS system in epilepsy and allows subsequent studies to advance as planned.
Genovate and NaviFUS will continue patient recruitment and treatment for the second cohort in Australia, while in parallel preparing and conducting NaviFUS epilepsy trials in the United States and Taiwan. By building a robust body of safety and efficacy data across regions, the companies aim to accelerate global access to NaviFUS neuromodulation for brain disorders and bring a new non-invasive treatment option to patients living with drug-resistant epilepsy.
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