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貝康醫療(2170.HK):BSG800A&BSG800C超低温液氮冷凍存儲系統獲得醫療器械註冊證
格隆匯 09-13 13:37
貝康醫療(2170.HK)今日盤中發佈自願性公吿,宣佈其BSG800A和BSG800C兩款液氮冷凍存儲系統正式獲得醫療器械註冊證(蘇械注準:20242221830)。其中,BSG800A型號專用於胚胎和卵子的凍存,BSG800C型號則適用於精子樣本的凍存,容量可達三萬個樣本。早在2022年,貝康便推出國內首款獲證的智能液氮罐BCT38系列(蘇械注準:20222221946),而此次新註冊的BSG800系列產品進一步豐富了貝康的冷凍存儲設備陣容。目前,許多生殖中心仍使用傳統的手工挑管和手工記錄方式進行胚胎、卵子和精子的管理。貝康的最新冷凍系列產品能夠顯著降低人為操作失誤帶來的醫療風險,為生殖中心提供全面的智能硬件升級方案,並大幅提升生殖中心的工作效率。根據《人類輔助生殖管理辦法》規定,冷凍胚胎至少需保存5年,預計每年全國新增約1000萬胚胎需要冷凍保存。值得一提的是,今年3月的全國兩會還提出了有關女性“凍卵”的議案。同時,細胞治療和創新藥物相關冷凍管理需求也在增長,以上都需要獲得註冊證的大容量、自動化、合規的產品才能滿足日益增長的市場需求。貝康作為最早佈局生育力保存的第一家輔助生殖領域IVD上市公司,藉助公司生殖領域核心產品的先發優勢,對於現有同一目標客户羣,從胚胎培養到精子檢測,再到生育力保存,已經構建了完整的產業鏈佈局,將最大程度地滿足未來生殖中心對硬件升級的需求,開啟生育力保存商業化新模式。
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