Posts

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. NaviFUS System is the world’s first FUS device that combines Neuronavigation – an optical tracking ...

Combination NaviFUS System and Bevacizumab Clinical Trial approved by TFDA

NaviFUS Corporation, Genovate Biotech (4130) subsidiary and high-end medical device company, completed its first safety and efficacy clinical trial for its focused ultrasound (FUS) device, NaviFUS System, last year in June. The trial consisted of six patients with Recurrent Glioblastoma (rGBM), and results showed that the system can precisely open the blood-brain barrier (BBB) with safe recovery afterwards. Because the trial conducted both safety and feasibility testing, Genovate stated that the phase of the trial was equivalent to a clinical phase I/IIa, setting the stage for its upcoming trial, which will test the combined use of NaviFUS System with chemotherapy drug. 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 tit...