鷹瞳科技-B(02251.HK)核心產品Airdoc-AIFUNDUS (2.0)完成臨牀試驗 試驗數據結果優異！
格隆匯9月14日丨鷹瞳科技-B(02251.HK)宣佈，公司已於近期完成其核心產品Airdoc-AIFUNDUS (2.0)的臨牀試驗，該產品為針對多適應症的人工智能輔助診斷醫療器械軟件(”SaMD“)。Airdoc-AIFUNDUS (2.0)的適應症覆蓋範圍從上一版本的糖尿病視網膜病變拓展至高血壓視網膜病變、視網膜靜脈阻塞及年齡相關性黃斑變性(”AMD“)，其覆蓋該等四種疾病的靈敏度和特異度表現結果優異，較之中國國家藥品監督管理局(”國家藥監局“)已批准的AirdocAIFUNNDUS (1.0)的靈敏度(91.75%)和特異度(93.10%)均有進一步提升。這充分體現了公司技術方面的競爭優勢，可以持續優化算法以提升其性能表現。憑藉行業領先的臨牀試驗結果，公司正在準備為該等新適應症向國家藥監局提交更新第三類醫療器械註冊證書的申請。Airdoc-AIFUNDUS (2.0)是國內首款完成臨牀試驗並可以向國家藥監局提交註冊申請的增加多類適應症的人工智能輔助診斷SaMD，這不僅增加了公司未來在臨牀科室的應用範圍，也讓公司在競爭中領先一步。
隨着國內人口老齡化加劇，慢病和眼病的發病率都持續上升。由於患者數量眾多而醫療資源有限，高效檢出該等疾病具有巨大但未被滿足的臨牀需求。公司的Airdoc-AIFUNDUS (2.0)旨在覆蓋龐大的患者羣體，然而國內資深的視網膜醫生數量非常稀少。高血壓視網膜病變是患有高血壓可能發生的併發症，被視為判斷和監測嚴重高血壓的最重要因素之一。作為國內最常見的慢病之一，根據《中國心血管健康與疾病報吿(2021)》顯示，國內高血壓患者數量高達2.45億，然而疾病控制率僅不足20%。視網膜靜脈阻塞又被稱為”眼中風“，是一種常見的視網膜血管疾病，而視網膜中央靜脈阻塞時常伴隨缺血性腦卒中發生。根據2019年中國疾病預防控制中心和美國華盛頓大學健康測量及評價研究所聯合在《柳葉刀》上發表的研究論文顯示，腦卒中(俗稱”中風“)是中國首位致死因素。另外，AMD是50歲以上成人視力損傷的主要因素之一。隨着Airdoc-AIFUNDUS (2.0)增加覆蓋了高血壓視網膜病變、視網膜靜脈阻塞和AMD，該產品獲批後將可以協助醫生在心血管科、神經科和眼科檢測和診斷相關疾病，也將有助於持續監測相關藥物的臨牀效果，這預期都將有望大幅提高該產品在院內的滲透率及銷售機會和市場空間。
此 外，心血管疾病給中國公共健康系統造成的負擔日益加重，AirdocAIFUNDUS (2.0)獲批後也能夠讓公司更好地為解決國內公共健康問題盡一份力，尤其是在缺少優質醫療資源的基層醫療機構中使用。此外，為AirdocAIFUNDUS (2.0)研發的算法模型也可以為開展相關疾病的大規模篩查奠定紮實基礎，同時還可以為人們的個人健康管理及保險公司和健康管理機構的健康管理服務做出貢獻。這也代表着公司向實現普惠醫療的目標及讓健康無處不在的使命更近一步。
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