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