正海生物(300653.SZ):硬脑(脊)膜补片的医疗器械注册申请获受理
格隆汇9月22日丨正海生物(300653.SZ)公布,公司于近日收到国家药品监督管理局下发的医疗器械注册申请《受理通知书》。
产品名称:硬脑(脊)膜补片,临床用途:用于硬脑(脊)膜缺损的修复,申请人:烟台正海生物科技股份有限公司 ,产品类别:第三类医疗器械。
硬脑膜是脑组织表面一层双层膜性组织,其保护脑组织,防止脑脊液外流。颅脑损伤、肿瘤及其他颅脑疾病引起硬脑膜缺损时,需要用硬脑(脊)膜补片修补。市场上现有多种类型的硬脑(脊)膜补片,其中,动物组织来源的硬脑(脊)膜补片具备良好的生物相容性,临床应用广泛。
该产品硬脑(脊)膜补片属于动物组织来源的硬脑(脊)膜补片,在公司已上市产品可吸收硬脑(脊)膜补片(国械注准20143132038)工艺基础上研发,成分为异种牛脱细胞真皮基质,不仅可以起到屏障作用,还可以起到引导组织再生的作用,具有良好生物相容性,不易引起人体的免疫排斥反应,易于周围血管及上皮爬行。
该产品获得注册证将有利于保持公司神经外科领域的优势地位,由于目前尚处于受理阶段,对公司现有业务和经营业绩预计不会产生确定性影响;因产品注册上市、未来产品生产均存在诸多不确定性,公司无法预测该项目对公司未来业绩的影响。
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