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:第三類醫療器械。
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。市場上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,成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,由於目前尚處於受理階段,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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