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Showing posts from December, 2020

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

《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