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邁普醫學(301033.SZ):可吸收多層纖絲型再生氧化纖維素近日完成首例受試者隨機入組、正式進入臨牀試驗
格隆匯 11-24 19:28

格隆匯11月24日丨邁普醫學(301033.SZ)公佈,公司的研發項目“可吸收多層纖絲型再生氧化纖維素”於近日完成首例受試者隨機入組,正式進入臨牀試驗。試驗用醫療器械名稱:可吸收多層纖絲型再生氧化纖維素;臨牀用途:外科手術中,當結紮或其他傳統的止血方法無法操作或無效時,該產品作為輔助止血產品用於控制毛細血管、靜脈及小動脈的滲血。

公司已上市的“可吸收再生氧化纖維素”止血產品是專門針對神經外科手術止血需求所開發的高性能止血產品,2021年8月已首次取得該產品的國內醫療器械註冊證,產品獲證後公司積極推進國內各省市地區的掛網,已同步實現國內外的銷售。

基於外科手術止血材料的臨牀需求較大,但現有多以澱粉類產品為主,存在粘附性低,高膨脹性的問題,且產品止血後,在常見的臨牀生理鹽水沖洗操作後止血材料容易從創面沖走,造成二次出血等問題。因此,公司積極籌劃已上市的“可吸收再生氧化纖維素”止血產品的擴適應症工作,延伸至其他外科領域,擴大產品的適應症,以擴大品牌影響力。

根據前瞻產業研究院的統計數據顯示,2016-2019年全球可吸收止血材料呈現逐年上升態勢;從2016的184億元上升至2019年的224億元。在2020年,新冠疫情導致非緊急手術被批量推遲,手術量大幅減少,從而導致了可吸收止血材料銷售額的下降,2020年全球可吸收止血材料的銷售額為202億元。經初步統計,2021年全球可吸收止血材料的銷售額為219億元。

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