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正海生物(300653.SZ):硬腦(脊)膜補片的醫療器械註冊申請獲受理
格隆匯 09-22 19:32

格隆匯9月22日丨正海生物(300653.SZ)公佈,公司於近日收到國家藥品監督管理局下發的醫療器械註冊申請《受理通知書》

產品名稱硬腦(脊)膜補片臨牀用途:用於硬腦(脊)膜缺損的修復申請人:煙台正海生物科技股份有限公司 ,產品類別:第類醫療器械。

硬腦膜是腦組織表面一層雙層膜性組織,其保護腦組織,防止腦脊液外流。顱腦損傷、腫瘤及其他顱腦疾病引起硬腦膜缺損時,需要用硬腦(脊)膜補片修補。市場現有多種類型的硬腦(脊)膜補片,其中,動物組織來源的硬腦(脊)膜補片具備良好的生物相容性,臨牀應用廣泛。

該產品硬腦(脊)膜補片屬於動物組織來源的硬腦(脊)膜補片,在公司已上市產品可吸收硬腦(脊)膜補片(國械注準20143132038)工藝基礎上研發分為異種牛脱細胞真皮基質,不僅可以起到屏障作用,還可以起到引導組織再生的作用,具有良好生物相容性,不易引起人體的免疫排斥反應,易於周圍血管及上皮爬行。

該產品獲得註冊證將有利於保持公司神經外科領域的優勢地位由於目前處於受理階段,對公司現有業務和經營業績預計不會產生確定性影響;因產品注冊上市、未來產品生產均存在諸多不確定性,公司無法預測該項目對公司未來業績的影響。

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