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 embolization, RFA has shown great promise in that it is minimally invasive and can effectively eliminate tumors while reducing side effects, hospitalization needs, and recovery time. The global RFA device market size is estimated to reach US$3 billion in 2020.
The NAVIRFA Scope is a supplementary device for enhancing RFA needle surgery outcomes. Utilizing NaviFUS’ patented optical tracking technology, it can provide the projected trajectory of the needle during surgery, allowing the surgeon to make optimal decisions regarding the needle entry point and route to the tumor, as well as real-time adjustments to the needle angle. The technology behind the NAVIRFA Scope also has other potential clinical applications – such as the treatment of other cancers and biopsy – and NaviFUS is in the next stages of product development for the NAVIRFA Scope to expand its clinical footprint. CEO Arthur Lung has stated that the NAVIRFA Scope will first debut in the Taiwan market, with plans to eventually expand into other geographical markets such as the United States, China, and Southeast Asia.