• NaviFUS is a Taiwan-based manufacturer that is developing novel focused ultrasound brain systems.
  • Their devices are currently in human clinical trials for the treatment of brain tumors and epilepsy.
  • Biomechanisms in development include blood-brain barrier opening and neuromodulation.

Key Points

  • NaviFUS is a Taiwan-based manufacturer that is developing novel focused ultrasound brain systems.
  • Their devices are currently in human clinical trials for the treatment of brain tumors and epilepsy.
  • Biomechanisms in development include blood-brain barrier opening and neuromodulation.

NaviFUS logo2Since 2015, Taiwan-based NaviFUS Corporation has designed and manufactured neuronavigation- and ultrasound-guided focused ultrasound systems for the treatment of brain diseases and disorders. Their three current devices are being used in clinical trials for brain tumors, epilepsy, and soon, Alzheimer’s disease. We recently worked with our Chief Advisor of Asia, Jessica Che-yi Chao, who visited the company and corresponded with CEO Arthur Lung, PhD, to learn more. NaviFUS representatives were kind to answer our Q&A and further describe the company’s innovative strategies for applying focused ultrasound to the brain.

Where is the company headquartered?
NaviFUS Corporation Headquarters | Taipei, Taiwan
12F, No. 246, Sec. 3, Chengde Rd., Datong Dist., Taipei City 103, Taiwan

How was the company started?
NaviFUS was founded in 2015 as a culmination of years of novel academic research by Dr. Hao-Li Liu in ultrasound technology at the Department of Electrical Engineering of Chang Gung University in Taiwan. Since then, the company has teamed up with local hospitals and other experts in the biomedical, medical device, pharmaceutical, and regulatory domain to conduct clinical trials for the treatment of brain tumors and epilepsy in Taiwan. In 2018, the company co-invested with Genovate Biotechnology Co., Ltd., to establish a subsidiary company in Australia, which will soon begin a clinical trial for focused ultrasound therapy in Alzheimer’s Disease.

How did you get involved in starting or joining the company?
When Dr. Liu joined Dr. Kullervo Hynynen’s Lab as a postdoctoral fellow at Brigham and Women’s Hospital, he was able to see first-hand the clinical success of focused ultrasound in uterine fibroid thermal therapy. After completing his research in medical applications of focused ultrasound and returning to Taiwan in 2005, Dr. Liu dedicated his research to develop the technology through NSC government funding, private foundation funding, and a national award. He designed a medical device for animal studies, then added phased-array technology to translate the model from preclinical animal studies to human clinical trials. This led to the development of the NaviFUS System prototype, and in 2015, NaviFUS was founded.

Tell us about your company structure: ownership, lead executives, and their roles.
Jen Chen, PhD | Chairman of the Board - Dr. Chen has over 30 years of new drug discovery and development experience, holding previous positions at Novartis and Genelabs. He founded Genovate Biotech in Taiwan and launched its IPO as an over the counter (OTC) company. Dr. Chen also currently presides over other public and OTC biotech companies in Taiwan, with the vision of elevating Taiwan’s footprint in the global biotechnology industry.

Arthur Lung, PhD | CEO - Dr. Lung holds MSc and PhD degrees in Biomechanics from the University of Wisconsin-Madison and National Yang-Ming University, respectively. He has over 25 years of medical device product design, development, marketing, and selling experience, which has translated into 24 product launches during his career at United Orthopedic and Medtronic. He also has extensive entrepreneurship experience in the healthcare industry.

Hao-Li Liu, PhD | CTO - Dr. Liu completed his post-doctoral training at Harvard University and is the Chief Technology Officer (CTO) at NaviFUS. He is also a Distinguished Professor in the Department of Electrical Engineering at National Taiwan University. He has published more than 130 science citation index papers and has filed over 30 patents for biomedical uses of therapeutic ultrasound. He is the primary architect behind the NaviFUS system and its uses in central nervous system (CNS) diseases.

In general, what is the current status of your company?
NaviFUS is at the phase II stage for its recurrent glioblastoma multiform (rGBM) and epilepsy clinical trials in Taiwan. Development of the Model -001 is currently focused on three major clinical indications: rGBM, epilepsy, and Alzheimer’s disease.

Besides the NaviFUS system, the company is also in development of an ultrasound-guided navigation system for radiofrequency ablation (RFA) surgery. Currently, it is in the stage of acquiring approval for the 510K license from the US FDA and the Taiwan FDA.

The company successfully secured Series A1, A2, and A3 funding in 2016, 2018, and 2020, respectively, for a total of $18.3 million US dollars from venture capital and pharmaceutical firms in Taiwan. NaviFUS is also looking to release an initial public offering (IPO) on the Taiwan OTC market in the next two years, to help fund subsequent clinical trials.

How many years has your treatment platform been in development, and what are its origins? 
Dr. Liu conceptualized the design when he returned to Taiwan in 2005 and generated the first NaviFUS system prototype in 2015. Since then, we have designed and are planning three different products: one for research purposes and clinical trials, and the other two specifically for clinical use in the future. Currently, we do not have the final commercial name for each system and are using a temporary numbering system as a placeholder to highlight the different clinical functions.

Our product categories are:
NaviFUS model 101—Research & Clinical Trials
NaviFUS model 201—BBB opening
NaviFUS model 301—Neuromodulation

What are some of the technical challenges your group has had to overcome to develop a fully noninvasive system?
One major technical challenge is finding a safe and accurate way to guide focused ultrasound to target deep tissue in the CNS. Another big issue is accurately predicting the transcranial energy deposition amount and location.

What challenges do you have to tackle moving forward?
The greatest challenges for a start-up company like NaviFUS are the costs and scalability of clinical trials. We have demonstrated in our previous trial that our focused ultrasound technology can safely open the BBB in rGBM patients. However, we need more robust clinical data and positive results to justify that our technique’s clinical benefits outweigh the potential risks.

In order to get enough clinical evidence, we need to complete more clinical trials, which will require significant time, money, and other resources. After we acquire enough data and get regulatory approval to commercialize our device, NaviFUS can develop more products to benefit more patients. So currently, how to successfully raise capital to improve the quality and execution of clinical trials is the greatest challenge moving forward.

Tell us about your clinical studies and the results.
NaviFUS is now proceeding with phase II clinical trials for rGBM and epilepsy in Taiwan and the US. NaviFUS will also begin a Phase I Alzheimer’s disease clinical trial in Australia within the next few months.

In 2019, NaviFUS successfully completed the world’s first-in-human clinical trial using a noninvasive method (NaviFUS system) to open the BBB in 6 rGBM patients at Linkou Chang Gung Memorial Hospital. All patients experienced safe recovery within 24 hours, and there were no side effects related to focused ultrasound therapy. A second clinical trial testing the combined use of the NaviFUS system with Avastin began in June 2020. This trial will test the feasibility of delivering macromolecular drugs (normally nonpermeable) directly to brain tumors after noninvasive focused ultrasound–induced BBB opening. In parallel, NaviFUS is also cooperating with renowned doctors from Stanford Hospital and regulatory experts to help expand clinical trial testing in the US, with the goal of commencing clinical operations in 2022.

In June 2019, NaviFUS presented results from its epilepsy safety trial at Taipei Veterans General Hospital showing that focused ultrasound neuromodulation can safely reduce seizure frequency. NaviFUS has also collaborated with Stanford University since 2019 on a focused ultrasound treatment in a chronic epilepsy animal model and are building on promising preliminary results.

In January 2019, NaviFUS and Genovate Biotech established a joint venture company in Australia to start a clinical trial for therapeutic use of focused ultrasound in Alzheimer's disease. Applications were filed in 2019 and approved to kick-off in 2020 Q3, so we expect enrollment to begin at the Alfred Hospital in Australia in Q3 2021. This clinical trial will use noninvasive focused ultrasound to stimulate hippocampal neurons and rejuvenate the neurodegenerative pathophysiology of Alzheimer’s disease.

NaviFUS System Current Clinical Pipeline

NaviFUS Clinical Pipeline

What are the benefits of your technology over other companies?
Features & Benefits
The NaviFUS system uses neuronavigation technology for focused ultrasound guidance. The patient only needs to sit in a chair to receive focused ultrasound treatment for less than a half-hour, with no need to drill holes on the skull.

Benefits: Accurately targets deep CNS tissues, such as the hippocampus region
Care setting: Outpatient, intraoperatively MRI-free
Treatment time: Less than 30 minutes, noninvasive, no anesthesia needed
Uses: Drug delivery for CNS diseases, neuromodulation
Disease indications: rGBM, epilepsy, Alzheimer’s, Parkinson’s, depression
Personalization: Personalized treatment planning

Competitive Advantages
The NaviFUS system provides a noninvasive, cost-effective, and user-friendly focused ultrasound system that can provide a variety of clinical applications, such as drug delivery, neuromodulation, immuno-stimulation, and more. NaviFUS has held exclusive patents in focused ultrasound and medical imaging with 3D localization technology since 2015. Recently, NaviFUS has also established its credibility both locally and globally, which has led to accelerated regulatory approval from the Taiwan FDA/CDE and financial support from the Focused Ultrasound Foundation.

Have you learned any lessons for watching the experience of the other companies?
NOVOCURE’s story is an example of a successful case study for us. When the theory of using a tumor treating field to treat GBM was announced, not all neurosurgeons accepted that it could be an effective treatment. However, after a decade of clinical trials, their product had been approved by the FDA. We believe that learning from their experience can help NaviFUS in acquiring regulatory approval for its focused ultrasound devices and avoid pitfalls faced for new and emerging medical devices.

Do you partner with other companies?
We are supported by numerous venture capital and healthcare investors, and we have partnered with international distributors, physicians, medical institutions, academic researchers, and patient advocacy groups around the world.

Taiwan

  • Linkou Chang Gung Memorial Hospital (rGBM)
  • Taipei Veterans General Hospital (epilepsy)
  • Genovate Biotech

USA

  • Stanford University Hospital (rGBM, epilepsy)
  • Harvard University (metastatic tumors/epilepsy)

Australia

  • The Alfred Hospital (Alzheimer’s disease)

Advocacy Groups

  • The Focused Ultrasound Foundation

Is your system approved for commercial use in any markets? If so, how is it being used in these markets?
No, it is not yet approved.

Which health conditions or diseases will your technology be used for?
The NaviFUS system will be used in the treatment of CNS diseases such as GBM, epilepsy, and Alzheimer’s Disease, all of which can be treated noninvasively through methods such as opening the BBB or neuromodulation.

Is there anything else we should know about your company?
NaviFUS also holds exclusive patents in medical imaging and 3D localization technology, which is being used to develop an ultrasound-guided navigation system for RFA surgery and other procedures that require needle guidance. Currently, it is in the stage of acquiring 510K approval from the US FDA and the Taiwan FDA.

Past Coverage
NaviFUS Publishes Initial Glioblastoma Clinical Trial Results February 2021
New Clinical Trial for Focused Ultrasound in Glioblastoma September 2020
Hope on the Horizon – Focused Ultrasound Therapy for Brain Tumors May 2020
NaviFUS Launches Brain Tumor Clinical Trial in Taiwan November 2018
Research Roundup October 2018
Symposium Showcases Latest Advances in Noninvasive Therapy for Brain Disorders, Cancer and Other Major Diseases October 2018
NaviFUS Executives Visit Foundation February 2017
New Focused Ultrasound Companies Formed in Taiwan November 2015

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