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. There are approximately one million liver cancer patients worldwide, and the Asia-Pacific market has an annual growth rate of 12.67%; it is a market that urgently needs new treatment methods. In comparison with other first-line treatments such as surgery and hepatic artery emboliz...