NaviFUS Corporation Finalist for 2022 Edison Awards
Innovative focused ultrasound (FUS) platform technology gets good results for its remarkable capabilities in treatment of brain diseases
NaviFUS Corporation’s “Neuronavigation-guided Focused Ultrasound System” has recently been shortlisted for the 2022 Edison Award – Science & Medical Outpatient Treatment category – together with global pharmaceutical giant Abbott and Spark Medical Inc. (market value: US$4.4 billion). Final results for the gold, silver, and bronze medals will be announced in April in Florida, USA. The news is an affirmation that NaviFUS can compete side by side with other first-rate companies around the world, and Taiwan’s innovative talent is once again visible on the world stage.
The Edison Award was established by the Institute of Electrical and Electronic Engineers (IEEE) in 1987 to recognize companies or research institutions with innovative and outstanding achievements in the fields of electrical and electronic engineering; it can be called the “Oscar of Innovation”. Previous companies and founders who have won the award include Apple (Steve Jobs), Tesla (Elon Musk) and Procter & Gamble (Alan G. Lafley).
NaviFUS Corp. has two main core technology platforms in development: “Focused Ultrasound System ” and “Therapeutic Guidance Assistance System”. The clinical problem they are trying to solve is creating a way for macromolecular drugs to pass through the ‘blood-brain barrier’ to treat brain diseases. NaviFUS’ FUS technology utilizes a ‘non-invasive method’, supplemented by ‘precise navigation’. “The blood-brain barrier is opened or neuro-regulated, thereby improving the efficacy and safety of related drugs in brain diseases, or even directly regulating the affected lesions to achieve therapeutic effects.
According to an evaluation report published by Nature Reviews Neurology in 2021, the top three companies in the world today developing FUS therapy technology for brain diseases are Insightec (previous gold medal winner of the Edison Award in 2018 and has a market value of about $1.5 billion) in Israel, Carthera in France, and NaviFUS in Taiwan.
Prospective nominations for the Edison Award are judged by the panel according to four criteria: Concept, Value, Delivery, and Impact. In its application materials, NaviFUS referenced its previous completed first-in-human rGBM trial and the published clinical report in Science Advance in 2021, which clearly summarized how the blood-brain-barrier had been precisely opened and then safely closed in 6 rGBM patients. NaviFUS also presented the clinical report for its previous FUS study on six patients with drug-resistant epilepsy published in Epilepsia in 2022, which showed that initial safety and efficacy results were in line with expectations.
At present, NaviFUS is continuing its phase II clinical trial (NCT04446416) to evaluate the safety and efficacy of FUS and Bevacizumab (Avastin) in penetrating the blood-brain barrier for treatment of recurrent glioblastoma; its phase II clinical trial for drug-resistant epilepsy (NCT04999046) has also successfully begun recruitment, and it will observe the effects of treatment optimization in patients. NaviFUS expects to have preliminary results for these two phase II clinical efficacy trials by the end of this year.
The Edison Award also requires applicants to describe some of the challenges faced in their own industry (i.e., focused ultrasound devices) in commercializing new technologies. Basically, if a new technology or product is used for the treatment of patients, the three biggest challenges are a clear roadmap to regulatory approval, comprehensive clinical safety testing and efficacy verification, and development of sustainable post-market payment models; to overcome these challenges, we emphasize the necessity of having a united, experienced team and supportive funding to pioneer a new era for the diagnosis and treatment of brain diseases.
“NaviFUS acknowledges that the support and guidance from Taiwan Food and Drug Administration (TFDA) and the Center for Drug Evaluation (CDE) were an important factor in NaviFUS’ clinical achievements and even its nomination into the Edison Awards Finalists. The encouragement and advice from their Priority Review consultation enabled clinical trials for recurrent brain cancers and drug-resistant epilepsy to be carried out one after another”, Dr. Jen Chen, Board Chairman, stated with gratitude. Recently, NaviFUS has made moves to ramp up its global imprint. Last year, it completed public issuance and registration on the Emerging Stock Board (TPEx: 6872) in preparation for IPO. At the end of January, it submitted IDE application documents for another rGBM trial evaluating FUS treatment with Bevacizumab (Avastin) at Stanford University in the United States. In addition, once the Covid epidemic has gotten better in Australia, an Alzheimer’s disease (AD) clinical phase I/II trial in cooperation with Genovate Biotech in Melbourne is expected to start in 2022 Q2, which will enable NaviFUS to continue to improve its visibility on the world stage.
Dr. Chen also pointed out that doing well in the Edison Awards will help accelerate NaviFUS’ search for strategic alliances that could provide access to resources and experts around the world, allowing NaviFUS to scale up and compete with other world-class biotech industries; furthermore, it could help increase the availability of NaviFUS technology to patients with brain diseases around the world, and consequently elevate the company’s operations and value.
View 2022 Edison Awards Finalist >
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