NaviFUS Corporation, a rising star in the biotech industry, has developed NaviFUS, a focused ultrasound therapy for brain tumors. After becoming one of the top three companies globally with technology for treating brain disorders, Chairman Chen Cheng stated that they have already attracted discussions for collaboration and licensing with international pharmaceutical and medical device companies. Internally, apart from accelerating clinical trials for brain tumors and refractory epilepsy, they aim to apply for listing on the stock exchange by the second half of this year.
NaviFUS Corp.'s NaviFUS, alongside Israel's Insightec and France's Carthera, stands as one of the leading companies globally in focused ultrasound therapy for brain disorders. The NaviFUS system, when used in combination with the drug Avastin, can open the blood-brain barrier to achieve therapeutic effects. In recent years, it has garnered significant attention from international industry players. The company's recent round of funding has attracted additional investment from groups such as Acer's founder Shih Chen-rong's Qunxin/Himalaya and Yiding, facilitating successful fundraising.
General Manager Long Cheng-yu stated that several international pharmaceutical companies have approached them for discussions. The fastest-progressing project involves combining Avastin for treating recurrent malignant brain tumors, which is set to begin phase III pivotal trials, expected to enroll 26 participants, with 13 each in the drug and placebo groups. Additionally, clinical trials for refractory epilepsy type 2b are planned to be completed this year in Taiwan, the United States, and Australia.
Moreover, a pivotal clinical trial combining NaviFUS with the drug Bevacizumab (BEV) for recurrent glioblastoma multiforme received approval to commence in Taiwan in January this year and is currently actively recruiting participants. In February, they also obtained Investigational Device Exemption (IDE) approval from the US FDA, enabling the commencement of human trials combining the NaviFUS system with Bevacizumab for recurrent brain tumors at the University of Virginia Hospital. This will help reduce regulatory barriers for future applications overseas (in the US) and facilitate pivotal trials conducted locally.
Apart from conducting clinical trials for recurrent brain tumors with NaviFUS, clinical trials for refractory epilepsy using ultrasound energy for neuromodulation are ongoing in Taiwan. Preliminary efficacy and safety results were presented at the International Epilepsy Congress held in Dublin, Ireland, in October last year, showing significant improvement in seizure frequency within 2 to 6 months post-surgery.
In seeking future treatment designs, NaviFUS Corp. has initiated trials in collaboration with a subsidiary of Genovate Biotechnology Co. Ltd., which commenced enrollment at The Alfred Hospital in Melbourne, Australia, in June last year. This year, they plan to initiate refractory epilepsy clinical trials in Taiwan (at Taipei Veterans General Hospital) and the United States (at Stanford University Epilepsy Center, University of Virginia Hospital, and Brigham and Women's Hospital within the Harvard Medical School system). Through differentiated prescription designs across three global locations, they aim to provide the optimal treatment prescriptions for clinical commercialization and promote international cooperation.
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