百心安-B(02185.HK):完成第二代IBERIS®臨牀試驗患者入組
格隆匯1月26日丨百心安-B(02185.HK)宣佈,於2022年1月26日,公司完成第二代Iberis®(由公司獨立開發的第二代腎神經阻斷(RDN)系統產品)臨牀試驗患者入組程序。腎神經阻斷為少數具有良好臨牀療效的器械療法之一,可治療不受控高血壓及頑固性高血壓,被眾多行業專家視為具有轉變高血壓治療模式的潛力。根據弗若斯特沙利文(北京)諮詢有限公司上海分公司("弗若斯特沙利文")的資料,預期第二代Iberis®將成為中國首款獲批准的多電極腎神經阻斷產品。與單電極腎神經阻斷在研產品相比,我們的第二代多電極Iberis®可有效減少手術時間及患者及醫生暴露在輻射之下的風險。此外,第二代Iberis®為中國唯一能夠使主要腎動脈及其分支聯合消融的多電極腎神經阻斷在研產品。我們相信,與僅可使主要腎動脈消融的在研產品相比,第二代Iberis®能夠提高腎神經阻斷手術的降血壓效果,弗若斯特沙利文同意這一點。第二代Iberis®於2016年11月被國家藥品監督管理局確認為"創新醫療器械",因此合資格進入快速審批程序。
展望未來,公司將持續進行其臨牀計劃,並與泰爾茂株式會社合作將第二代Iberis®推向市場。公司將繼續加強其內部研發能力,併為臨牀護理帶來創新。
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