NaviFUS wins Gold at 2022 Edison Awards
The “NaviFUS Focused Ultrasound System” developed by NaviFUS Corporation recently won Gold at the 2022 Edison Awards – Science & Medical Outpatient Treatment category on Apr. 22, 2022. Also competing in this category were other innovative products by renowned companies Abbott Laboratories and Spark Biomedical. For NaviFUS, this win marks another momentous step towards gaining international recognition, ever since it was acknowledged in a previous 2021 report in Nature Reviews Neurology (https://www.nature.com/articles/s41582-020-00418-z) as one of three global firms leading the development of focused ultrasound (FUS) therapy for brain disorders. Interestingly, one of the other 3 companies, Insightec – with a current market value of about 1.5 billion US dollars – was also a previous Gold winner at the Edison Awards in 2018. This win also has great meaning for NaviFUS in that it affirms its hard work in promoting the FUS industry and validates its technology as having the potential to transform the care of many brain disorders and thereby improve the lives of millions of patients around the world.
The “NaviFUS Focused Ultrasound System” is an innovative product that can safely and non-invasively perform FUS therapy in the clinic. Unlike its direct competitors that use intraoperative MRI guidance during treatment, the “NaviFUS Focused Ultrasound System” utilizes optical (infrared) guidance. Besides being non-invasive, optical guidance provides an alternative to MRI guidance, which can bottleneck FUS treatment in terms of cost, time, MRI availability, and scalability. For example, “NaviFUS Focused Ultrasound System” treatments can be completed in as fast as 30 minutes, are not affected by MRI scheduling or facility availability, and multiple treatments can be scheduled in a day. The “NaviFUS Focused Ultrasound System” aims to democratize FUS treatments throughout the world, by increasing accessibility, while at the same time decreasing cost.
NaviFUS had previously completed its first clinical trial demonstrating that the blood-brain-barrier can be precisely and safely opened using FUS and closed within 24 hours in six patients with recurrent brain cancer (rGBM); these results were published in Science Advance in 2021 (https://www.science.org/doi/10.1126/sciadv.abd0772). In 2022, results from NaviFUS’ first epilepsy trial were published in Epilepsia (https://onlinelibrary.wiley.com/doi/full/10.1111/epi.17105), and the preliminary results suggested that this treatment is safe and feasible. CEO and general manager Dr. Arthur Lung states that although “NaviFUS Focused Ultrasound System” still needs more patient data to verify the actual clinical efficacy, we believe that this product has only scratched the surface of its potential after sharing our clinical results with many physicians and experts and receiving positive feedback.
NaviFUS has several clinical trials that are ongoing or preparing to begin. It recently obtained US FDA approval for an IDE phase II trial combining FUS-induced BBB-opening with Bevacizumab (Avastin®) for the treatment of recurrent brain cancer in February this year, and it is planning to launch it at Stanford University in the United States. The same phase II trial (NCT04446416) has been underway in Taiwan at Linkou Chang Gung Memorial Hospital (CGMH) since 2020 and expects to be completed later this year. NaviFUS is also currently sponsoring two other clinical trials in Taiwan. Also in progress at CGMH is a clinical phase I trial (NCT04988750) evaluating the synergistic radiosensitizing effect FUS can have on radiation therapy for recurrent brain cancer. A phase II trial (NCT04999046) evaluating the effects of an optimized FUS neuromodulation treatment for refractory epilepsy patients is being conducted at Taipei Veterans General Hospital. NaviFUS expects the three clinical trials in Taiwan will all release preliminary results by the end of this year. Finally, another exciting phase I/II trial for FUS treatment of brain disorders will soon begin at The Alfred Hospital in Melbourne Australia.
Board Chairman Dr. Jen Chen offered a summary of NaviFUS’ next steps. “NaviFUS will build on its achievements over the last seven years by seeking international partnerships, agilely acquiring more resources so that it can compete with its peers in the FUS and medical device industry, and continuously fine-tuning the medical applications of its platform technology to generate value and expand NaviFUS’ imprint on the FUS landscape. NaviFUS is expected to launch in the Emerging Market of the Taipei Exchange in the first half of this year, with plans to launch in other capital markets (not limited to Taiwan) in the future.
About the Edison Awards
The Edison Best New Product Awards™ is an annual competition honoring excellence in new product and service development, marketing, human-centered design, and innovation. The competition is open to innovative organizations across the globe. The Edison Awards are focused on the innovators as much as the innovations – a unique distinction in the world of award programs. Award winners represent “game changing” products and services, as well as excellence and leadership in innovation around four criteria: Concept, Value, Delivery, and Impact. An Edison Award represents significant value to the award winner and to the cause of innovation and highlights the strong marketing value of an unbiased 3rd-party validation.
About NaviFUS NaviFUS Corporation is a medical device company in Taiwan dedicated to the continuous innovation of FUS solutions for clinically unmet needs in neuromedicine, such as the delivery of Central Nervous System (CNS) drugs past the blood-brain barrier (BBB). Our product, the NaviFUS System, utilizes non-invasive FUS energy to safely enhance BBB permeability and allow the delivery of small- or large-molecule CNS drugs to target tumor tissue at high precision. It is also capable of reducing seizure frequency in epilepsy patients through FUS-mediated neuromodulation.
Many CNS-related diseases currently have no effective treatment, and they will cause significant economic burdens in the future, if not already. Our vision is to help CNS disease patients everywhere and make our FUS technology available by providing safe, effective, and accessible FUS treatments.