堃博醫療-B(02216.HK):RF-II中國註冊性臨牀試驗入組圓滿完成
格隆匯12月10日丨堃博醫療-B(02216.HK)宣佈,公司已完成其自主研發的核心產品-專門針對肺癌的射頻消融系統,RF發生器+RF消融導管(簡稱"RF-II")的中國註冊性臨牀試驗所有受試者入組。
該臨牀試驗由廣州醫科大學第一附屬醫院(廣州呼吸健康研究院)作為組長單位,李時悦教授擔任協調PI(Principal Investigator,主要研究者),包括上海胸科醫院、四川大學華西醫院等在內的全國十數家權威臨牀中心共同參與。RF-II即刻消融手術順利,患者對手術耐受性良好。RF-II的安全性及有效性在部分已實現隨訪的患者中得到了初步顯示。
根據弗若斯特沙利文報吿,2020年,中國新發肺癌患者92.41萬人。射頻消融是一項微創、可重複的肺部腫瘤靶向療法,可以單獨或聯合治療,潛在地為多數患者提供治癒性和姑息治療機會。
公司自主研發的第二代射頻消融產品,是全球唯一一款專注肺癌治療的射頻消融系統,在增強現實光學全肺診療導航LungPro的引導下,經支氣管鏡入路,快速精準到達目標病灶中心,使用消融導管對腫瘤進行消融,為肺部腫瘤消融帶來介入治療創新技術。該系統有望為多原發肺癌、術後復發,或不適宜外科手術治療的肺癌患者提供全新的治療方式。
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