NaviFUS Receives Approval of Focused Ultrasound Trial to Enhance Radiotherapy

Taiwan-based manufacturer NaviFUS has announced it will begin a new clinical trial using its focused ultrasound therapy system to temporarily open the blood-brain barrier (BBB) as a way to increase efficacy of radiotherapy in patients with primary brain tumors.
Radiotherapy is a standard-of-care therapy for these patients, but research suggests that reduced blood flow and oxygen concentration in the tumor area inhibits the efficacy of radiotherapy. NaviFUS has conducted preclinical studies that suggest disrupting the BBB using their focused ultrasound system significantly increases the oxygen content of brain tissue, which – when combined with radiotherapy – can increase the tumor-inhibiting effect of the therapy. Results of these studies were presented at the Foundation’s 7th International Symposium on Focused Ultrasound. The upcoming clinical trial aims to confirm these results in humans.

New dawn for brain tumor radiotherapy research – NaviFUS begins FUS combined with radiotherapy clinical trial for the treatment of terminal primary brain tumors

 NaviFUS® was approved for an upcoming trial investigating the synergy of focused ultrasound treatment with radiotherapy in patients with end-stage primary brain tumors.
 Low radiotherapy doses may yield high-dose therapeutic effects and significantly reduce serious side effects attributed to high-dose radiotherapy.
 NaviFUS believes this treatment can also be extended to metastatic brain tumors from lung cancer, breast cancer, etc. The market potential for this treatment is expected to be more than $2 billion US dollars.

NaviFUS receives first overseas order for pre-clinical research FUS device

NaviFUS announced that it recently made its first overseas sale with its FUS System for Pre-Clinical Research. While the NaviFUS System is currently still in the process of acquiring pre-market approval, a modified version strictly for research purposes can be sold to academic and medical institutions, providing an alternative source of income to NaviFUS.

NaviFUS Publishes Initial Glioblastoma Clinical Trial Results

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 eyeing next year to launch new NAVIRFA Scope product in Taiwan and U.S. market

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…

NaviFUS highlights clinical trial data and device capabilities at virtual International Focused Ultrasound Symposium

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…

Dr. Kuo-Chen Wei Presents Recent Clinical Findings in SNO/FUS Foundation Online Webinar

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.

NaviFUS Launches Neuronavigation-guided Clinical Trial to Open the Blood-Brain-Barrier for Combination FUS-Bevacizumab Therapy in rGBM 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…

NaviFUS System Approved For Use in Alzheimer’s Disease Clinical Trial in Australia

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…

Combination NaviFUS System and Bevacizumab Clinical Trial approved by TFDA

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…