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

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 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
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《生醫股》浩宇生醫NAVIRFA Scope 明年台、美上市

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 健亞生技(4130)轉投資的浩宇生醫其開發應用於腫瘤消融產品(NAVIRFA Scope)，同步申請美國，台灣認證，預期將有機會在2021年取得核可上市銷售。 浩宇生醫治療肝癌的射頻消融術(Radio-Frequency Ablation, RFA)相關的產品NAVIRFA Scope，已在12月4日正式向美國FDA提出510(k)的醫材上市前通知申請，預計2021年中可取得核可；同步亦將平行申請台灣第二類醫材許可，並在10月31日已與華宇藥品簽署銷售代理合約，預計將於2021年取證後展開販售。 肝癌在全球約有近百萬名的患者，亞太市場年增長率更是來到12.67%，是亟待新治療方法介入的市場；除了切除手術或肝動脈栓塞等一線治療外，以RFA此種微創方式來進行肝腫瘤消融，可以有效消除腫瘤，且大幅減少病人副作用、住院需求及復原時間；RFA器材全球市場規模預估將在2020年來到30億美元。 輔助醫師操作RFA針具的NAVIRFA Scope產品，是屬於目前RFA針具的升級版(RFA2.0)。可在微創手術執行之前，使用浩宇的專利平台技術光學追蹤系統--Optical Tracking/Navigation System，預先確認針具進入皮膚的正確角度與到達預期腫瘤區域的路徑走向，使用於高階的NAVIRFA Scope消融手術，對比目前RFA1.0的作法，有三個重要潛在優勢。龍震宇總經理表示，NAVIRFA Scope由台灣市場出發，進一步擴展銷售至美國、中國大陸甚至是東南亞等具有肝癌治療需求的地區，逐步擴大其營收；NAVIRFA Scope除了肝癌治療外，亦可輔助其他癌症的RFA治療，甚或是應用於活體組織取樣（Biopsy），市場潛力不侷限於肝癌一項，浩宇將逐步開發其他用途產品，拓展NAVIRFA Scope的市場版圖。 《生醫股》浩宇生醫NAVIRFA Scope 明年台、美上市
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NaviFUS highlights clinical trial data and device capabilities at virtual International Focused Ultrasound Symposium

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 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
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浩宇参加国际聚焦式超音波年会

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 台北2020年11月27日 /美通社/ -- 浩宇生医股份有限公司（浩宇）参加美国聚焦式超音波协会於11月9日至13日举办第七届国际聚焦式超音波研讨会，5天会期中参加人员发表与交流“非侵入式医疗技术”的应用及发展现况。在新冠肺炎疫情之下，仍然吸引了较前届更多（约1700多位）的全球产业、医疗与学术界人士参与这项网路影音盛会。 浩宇於这次研讨会一共进行了4项影音及1项海报发表，并於前两天的会期中参与了3项线上论坛讨论，就刚结束收案的癫痫神经调控临床试验、正进行的复发性脑瘤併用化疗临床进度、规划中的脑瘤併用放疗试验及NaviFUS系统新开发的被动输出调整（Passive Cavitation Detection，PCD）功能，於会上发佈这些受国际瞩目的新进展。 台北荣总的癫痫试验已於10月顺利完成6位受试者的试验，在研讨会网站影音发表了目前初步结果，部份受试者可观察到症状发作及脑电波於治疗前後变化，并观察到对应的神经生理反应以NaviFUS系统进行神经调控的治疗方式应为安全可行；并於9日线上癫痫主题会议中，试验主持人尤香玉医师就这项领先的癫痫临床试验结果，与领域专家进行了高度交流讨论，相较於需植入电极的VNS/DBS之电刺激，或是高能超音波HIFUS的热烧，非侵入且不造成伤害之神经调控方式，将是有竞争力的癫痫治疗工具；故浩宇正规划下一阶段疗效试验，并持续进行与史丹佛大学的国际合作。 会中浩宇与脑瘤试验主持人魏国珍医师团队也发表了林口长庚临床试验的进展，继今年1月结案之6例證实NaviFUS系统於复发性脑瘤患者治疗安全可行之试验後，8月业已开始进行与癌思停併用之临床疗效试验，首位受试者长期配合癌思停投药週期，每两星期施做超音波治疗1次，目前已重複进行9次治疗而无发生与医疗器材相关之不良反应；10日的线上脑瘤主题会议上，除了复发性脑瘤的安全可行性试验之外，浩宇团队亦发表了目前併用放疗之临床前试验数据，显示透过血脑屏障的开启，将提升肿瘤冷区之血氧量，进而增强放疗之效果；未来将针对脑瘤第叁线复发病患进行试验，目前已完成法规谘询及试验规划，预备於年底前完成送件。 另外，新开发的PCD功能也於会上进行影音及海报发表，这项新功能在侦测出超音波输出达到空穴（Cavitation）效应临界点时，自动调降输出以防止产生的衝击波伤害血管组织，形成即时的安全防护迴路，让整个治疗可以在更有效安
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Dr. Kuo-Chen Wei Presents Recent Clinical Findings in SNO/FUS Foundation Online Webinar

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 On October 13, 2020, the Focused Ultrasound Foundation and the Society for Neuro-Oncology (SNO) hosted a webinar on ultrasound-mediated blood-brain barrier disruption (BBBD). Multiple clinical trials are ongoing or planned to investigate this rapidly developing approach to enhance small molecule, antibody, and cell delivery to brain tumors. This webinar brought together the pharmaceutical and biotech companies that are advancing this technology with investigators to provide an update on opportunities and challenges for using ultrasound BBBD to deliver therapeutics to brain tumor patients. Five brief presentations by experts across the field were followed by a Q&A discussion.   WATCH THE RECORDING >
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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

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 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>
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NaviFUS Launches Neuronavigation-guided Clinical Trial to Open the Blood-Brain-Barrier for Combination FUS-Bevacizumab Therapy in rGBM Patients

Genovate Biotech (TPEX:4130) subsidiary and Taiwan-based focused ultrasound (FUS) manufacturer NaviFUS Corporation is pleased to announce the start of its clinical trial (NCT04446416) for the combination of FUS plus bevacizumab therapy. Researchers at Linkou Chang Gung Memorial Hospital are investigating the use of Neuronavigation-guided FUS to repeatedly and temporarily open the blood-brain barrier (BBB) and enhance bevacizumab's efficacy in patients with recurrent glioblastoma (rGBM). To date, the first patient has been enrolled and is undergoing treatment. Led by neurosurgeon Dr. Kuo-Chen Wei at Linkou Chang Gung Memorial Hospital, the clinical trial will evaluate the safety and preliminary efficacy of repeated FUS-induced BBB opening with bevacizumab using the company's NaviFUS System. NaviFUS System utilizes neuronavigation and prior patient CT/MR images to guide the FUS energy. Additionally, the system includes a real-time acoustic emissions monitoring function that can p
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Location: 台灣
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