赛诺医疗(688108.SH)：子公司产品COMETIU支架国内注册未获批准

Core Viewpoint - Sino Medical (688108.SH) announced that its subsidiary, Sino Shenchang Medical Technology Co., Ltd., received a "medical device registration not approved" notice from the National Medical Products Administration (NMPA) for its COMETIU self-expanding intracranial drug-coated stent system [1] Group 1: Regulatory Approvals - The COMETIU stent's registration application was not approved by the NMPA, and the results have been publicly disclosed [1] - The company submitted an EU MDR certification application for the COMETIU stent to DEKRA Certification B.V. in October 2024, which has been accepted, and the product is currently in the final stage of technical review after passing the on-site quality system audit [1] Group 2: FDA Recognition - The COMETIU stent and COMEX balloon microcatheter received breakthrough medical device designation from the FDA in August 2025 [1] - This product is the first intracranial atherosclerotic stenosis treatment device to receive breakthrough designation in the history of the FDA's program and is also the first neuro-interventional device from China to achieve this recognition [1]