The clinical results from Taiwan-based NaviFUS’ first phase I clinical trial to open the blood-brain barrier (BBB) in patients with glioblastoma has been published in the journal Science Advances. In “Neuronavigation-Guided Focused Ultrasound for Transcranial Blood-Brain Barrier Opening and Immunostimulation in Brain Tumors,” researchers enrolled six patients with recurrent glioblastoma who were scheduled to undergo surgical resection.
“This is an important study to show the breadth and depth of worldwide research that is currently underway using focused ultrasound to treat these deadly brain tumors,” said Foundation Chairman Neal F. Kassell, MD. “We congratulate the authors and NaviFUS for developing this novel, safe, and innovative way to use the technology.”…
NaviFUS, a subsidiary of Genovate Biotech (4130), is developing a Radiofrequency Ablation (RFA) product called the NAVIRFA Scope. Simultaneous applications for regulatory approval are underway in both the United States and Taiwan.
NaviFUS has already submitted a pre-market notification 510(k) application to the U.S. FDA on December 4, 2020, and it expects to receive approval as early as mid-2021; at the same time, NaviFUS will also seek regulatory approval in Taiwan for the NAVIRFA Scope, and it has previously signed a sales distributor contract with UniPharma on October 31, 2020. NaviFUS believes that regulatory approval can also be acquired in 2021 and thus begin commercial sales in Taiwan…
TAIPEI, Nov. 27, 2020 /PRNewswire/ — The 7th International Focused Ultrasound Symposium organized by the U.S. Focused Ultrasound Foundation took place from 11/9 to 11/13 in virtual format this year due to the Covid-19 epidemic. During the 5-day conference, participants presented and exchanged information on the newest developments and applications of non-invasive Focused Ultrasound (FUS) technology. Likely the largest FUS event of the year, the virtual conference hosted over 1,700 industry, medical, and academic professionals from all over the world…
On October 13, 2020, the Focused Ultrasound Foundation and the Society for Neuro-Oncology (SNO) hosted a webinar on ultrasound-mediated blood-brain barrier disruption (BBBD).
Multiple clinical trials are ongoing or planned to investigate this rapidly developing approach to enhance small molecule, antibody, and cell delivery to brain tumors. This webinar brought together the pharmaceutical and biotech companies that are advancing this technology with investigators to provide an update on opportunities and challenges for using ultrasound BBBD to deliver therapeutics to brain tumor patients.
Genovate Biotech (TPEX:4130) subsidiary and Taiwan-based focused ultrasound (FUS) manufacturer NaviFUS Corporation is pleased to announce the start of its clinical trial (NCT04446416) for the combination of FUS plus bevacizumab therapy. Researchers at Linkou Chang Gung Memorial Hospital are investigating the use of Neuronavigation-guided FUS to repeatedly and temporarily open the blood-brain barrier (BBB) and enhance bevacizumab’s efficacy in patients with recurrent glioblastoma (rGBM). To date, the first patient has been enrolled and is undergoing treatment.
Led by neurosurgeon Dr. Kuo-Chen Wei at Linkou Chang Gung Memorial Hospital, the clinical trial will evaluate the safety and preliminary efficacy of repeated FUS-induced BBB opening with bevacizumab using the company’s NaviFUS System…
Genovate Biotech (4130) subsidiary NaviFUS has scored some more good news on its R&D front. Not long after receiving approval for its rGBM clinical trial in Taiwan, NaviFUS has also received approval to begin human clinical trials for Alzheimer’s Disease treatment in Australia. The company is a world-leading developer of transcranial focused ultrasound (FUS) technology specializing in safely and non-invasively delivering FUS energy into the brain.
Genovate has stated that the NaviFUS system can be used to treat Central Nervous System (CNS) diseases and plans to conduct its first clinical trial for the treatment of Alzheimer’s Disease in Australia to evaluate safety and efficacy. This trial was approved by the Innovations Committee and Ethics Committee in mid-August at The Alfred Hospital in Monash University, one of the most prestigious academic-medical institutions in Australia…
The NaviFUS System is noninvasive and can greatly reduce the risk of opening the blood-brain barrier (BBB) while simultaneously enhancing drug delivery to the brain; NaviFUS has completed the paperwork for the upcoming clinical trial application, and after being approved by the TFDA in March 2020, the clinical trial titled ” Efficacy and Safety of NaviFUS System add-on Bevacizumab (Avastin) in Recurrent GBM Patients” is expected to begin in Q3 of this year at Chang Gung Memorial Hospital Linkou…
NAVIRFA, a new 3D image-guided medical system NaviFUS has been developing, was recently showcased at the 1st International Asia-Pacific Advancements in Medical Ultrasound Forum. Currently in the verification and testing stage, NAVIRFA can help solve “unmet needs” of current RFA surgery practices through innovative 3D imaging and other diagnostic improvements in accuracy and speed. It is expected to obtain US and Taiwan marketing authorization next year. NAVIRFA will primarily be applied to liver cancer patients, which comprise a rapidly growing population of cancer patients. Liver cancer is the sixth most common cancer in the world, with Taiwan and Asia as the most prevalent regions. The new technology behind NAVIRFA is primed to helping alleviate the liver disease burden in Asia Pacific and meeting escalating market demand…
NaviFUS qualified for entry into the 2019 Taipei Biotech Awards and will present at the prize-winners’ pavilion during the event at Nangang Exhibition Hall. NaviFUS also announced that the safety study for “Focused Ultrasound-induced Blood Brain Barrier (BBB) Disruption in recurrent Glioblastoma patients” has been completed in June, with the case report to be completed in August. The study was conducted at Linkou Chang Gung Memorial Hospital, and none of the subjects had developed any treatment-related side effects. CEO Dr. Arthur Lung stated that the next step would be to continue towards Proof-of-Concept phase study, and he expressed that this project would be a major proponent of NaviFUS’ product line. NaviFUS has also been conducting a safety study for another epilepsy clinical trial recently at Taipei Veterans General Hospital and has completed its first FIH case in June; the study is currently in the stage of continuing to recruit more patients. Also, continuing its previous collaboration with experts in brain tumors and epilepsy from Stanford University…
We recently had the pleasure of hosting FUS Foundation’s Chairman Neal F. Kassell and Asia Program Director Jessica Lukens, and Council Member Jessica Chao again at NaviFUS. As a focused ultrasound company in Asia, NaviFUS was visited by FUS Foundation as part of its ongoing Asia program. Chairman Jen Chen, CEO Arthur Lung, and CTO Hao-Li Liu gave them a tour of NaviFUS’ facilities and discussed with them the current state of NaviFUS’ operations, potential collaborations and opportunities with FUS Foundation, and landscape of FUS technology in Taiwan and Asia…
