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康灃生物-B(06922.HK):冷凍粘連治療系統的一次性使用冷凍探頭變更註冊獲得國家藥監局批文

格隆匯8月7日丨康灃生物-B(06922.HK)發佈公告,繼集團的冷凍粘連治療系統,集團的呼吸介入產品之一,的其他部件(即一次性使用冷凍探頭)於2024年1月9日獲得國家藥品監督管理局授出的批文後,一次性使用冷凍探頭註冊變更爲冷凍探頭已於2025年8月5日獲得國家藥監局授出的批文。

在獲得國家藥監局授出的該等批文後,集團的冷凍粘連治療系統商業化路徑將更加完善,冷凍探頭將以一次性及重複使用的產品特性對相關適應症進行全面覆蓋。

冷凍粘連治療系統採用亞臨界製冷技術及控壓傳熱技術進行快速冷凍粘連,將用於氣道內異物、黏液、血液凝塊和壞死組織的冷凍去除以及支氣管和肺部組織的冷凍活檢。

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