NaviFUS System Approved For Use in Alzheimer’s Disease Clinical Trial in Australia

Genovate Biotech (4130) subsidiary NaviFUS has scored some more good news on its R&D front. Not long after receiving approval for its rGBM clinical trial in Taiwan, NaviFUS has also received approval to begin human clinical trials for Alzheimer’s Disease treatment in Australia. The company is a world-leading developer of transcranial focused ultrasound (FUS) technology specializing in safely and non-invasively delivering FUS energy into the brain.


Genovate has stated that the NaviFUS system can be used to treat Central Nervous System (CNS) diseases and plans to conduct its first clinical trial for the treatment of Alzheimer's Disease in Australia to evaluate safety and efficacy. This trial was approved by the Innovations Committee and Ethics Committee in mid-August at The Alfred Hospital in Monash University, one of the most prestigious academic-medical institutions in Australia. NaviFUS System is the world’s first FUS device that combines Neuronavigation – an optical tracking system commonly used in neurosurgery – and NaviFUS’ patented technology, allowing FUS energy to be directed to the hippocampus with pinpoint accuracy.


To our knowledge, the only medical device approved by the European Union at this time for the treatment of Alzheimer’s disease is the Transcranial Pulse Stimulation (TPS) device developed by Swiss company Storz Medical. It has been reported to help maintain cognitive abilities or improve Alzheimer’s Disease symptoms. The device uses continuous and repeated single acoustic pulses that can stimulate the brain to a depth of about 8 cm, but its mechanism does not involve opening the Blood-Brain Barrier (BBB).


The NaviFUS System provides a new treatment method. Guided by a precise navigation method, it releases FUS energy to a depth of about 10 cm in the brain to the hippocampus. This can effectively and temporarily open the BBB, improve circulation, reduce the accumulation of amyloid-β (Aβ) and Tau protein, and activate the scavenger effect of microglia to help promote neurogenesis; the clinical applications mentioned all present potential interventions to help treat Alzheimer's Disease.


 Genovate’s CEO Cindy Zhu stated that about 20-30% of healthy elderly people have moderate to high levels of Aβ, but do not exhibit obvious cognitive decline. The hippocampus is usually the most affected region of the brain in Alzheimer’s Disease patients, and it also plays a major role in neurogenesis in normal adult brains. NaviFUS hypothesizes that given the NaviFUS System’s clinical applications, under the long-term and repeated exposure in the hippocampal region, it can help promote amyloid plaque clearance and stimulate neurogenesis, leading to a translational therapeutic effect.


 Chairman Jen Chen pointed out that the NaviFUS trial in Australia will be the world's first clinical trial demonstrating the utility of a Neuronavigation-guided FUS device for neural stimulation in Alzheimer’s Disease patients. The trial will measure Alzheimer’s Disease-related indices and biomarkers such as Aβ and Tau protein as endpoints; in addition, the trial will also monitor Depression symptoms as an endpoint and explore possible correlations with Alzheimer’s Disease, since it has been reported to have strong comorbidity with neurodegenerative diseases.

 

https://m.ctee.com.tw/livenews/aj/a88131002020081814014302

 

Location: 台灣

Comments

Post a Comment

Popular posts from this blog

NaviFUS eyeing next year to launch new NAVIRFA Scope product in Taiwan and U.S. market

Image
 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
Read more

NaviFUS highlights clinical trial data and device capabilities at virtual International Focused Ultrasound Symposium

Image
 TAIPEI, Nov. 27, 2020 /PRNewswire/ -- The 7th International Focused Ultrasound Symposium organized by the U.S. Focused Ultrasound Foundation took place from 11/9 to 11/13 in virtual format this year due to the Covid-19 epidemic. During the 5-day conference, participants presented and exchanged information on the newest developments and applications of non-invasive Focused Ultrasound (FUS) technology. Likely the largest FUS event of the year, the virtual conference hosted over 1,700 industry, medical, and academic professionals from all over the world. NaviFUS was heavily involved in the virtual conference this year; posting 3 recorded oral presentations and 1 poster presentation, and also participating in 2 panel discussions during the first two days of the conference. Notable highlights from NaviFUS at the conference include its Epilepsy neuromodulation clinical trial that just finished its safety phase, preliminary progress from its FUS combined with Avastin in rGBM patients clinica
Read more

魏國珍醫師於SNO神經腫瘤學會/FUS聚焦式超音波協會網路研討會中介紹最近臨床發現

Image
 2020 年 10 月 13 日，SNO神經腫瘤學會/FUS基金會舉辦關於聚焦式超音波破壞血腦屏障（BBBD） 的網路研討會。 目前有多項計畫與正在進行的臨床試驗，在研究這種迅速發展的方法，來增強小分子、抗體和細胞向腦腫瘤的傳遞。 此網路研討聚集製藥公司及生物技術公司，提供研究人員們一起推動這項技術，以及有關使用聚焦式超音波破壞血腦屏障（BBBD）於腦腫瘤患者上的最新機會與挑戰資訊。 五位領域專家簡報，隨後進行問答討論。  觀看更多>
Read more