Core Viewpoint - The company, HeartLink Medical-B (02160.HK), has announced significant growth in its VitaFow® series of transcatheter aortic valves and delivery systems (TAVI), with a cumulative implantation of nearly 1,300 cases across 35 countries and regions as of the announcement date [1] Group 1: Market Expansion - The projected implantation volume for 2025 is expected to exceed 850 cases, representing an increase of nearly 350% compared to 2024 [1] - In the second half of 2025, the implantation volume is anticipated to grow by over 170% compared to the first half, driven by the commercialization of VitaFowLiberty® following CE mark approval in European countries and continued market share growth in emerging markets in Asia and Latin America [1] Group 2: Strategic Enhancements - The company's board believes that the recent acquisition of Micro-Invasive Cardiac Management will strengthen local channel resources and clinical support systems in mature markets like Europe, significantly improving market access efficiency for TAVI products [1] - The company aims to continuously leverage the synergies from business integration, advance the research and clinical progress of next-generation TAVI products, and enhance its overall competitiveness in the global valve treatment sector [1]

Core Viewpoint - MicroPort CardioFlow-B (02160) has announced significant growth in its VitaFow series transcatheter aortic valves and delivery systems, with a global presence in 35 countries and nearly 1,300 implants to date [1] Group 1: Market Expansion - The company expects to exceed 850 implants in 2025, representing a nearly 350% increase compared to 2024 [1] - In the second half of 2025, the implant volume is projected to grow by over 170% compared to the first half, driven by the commercialization of VitaFow Liberty in Europe following CE certification and increased market share in emerging markets in Asia and Latin America [1] Group 2: Strategic Development - The board believes that the recent acquisition of MicroPort Cardiac Rhythm Management will enhance local channel resources and clinical support systems in mature markets like Europe, significantly improving market access efficiency for TAVI products [1] - The company aims to continuously leverage the synergies from business integration, advancing the research and clinical progress of next-generation TAVI products, and enhancing its comprehensive competitiveness in the global valve treatment sector [1]

Core Insights - The early feasibility study results for the AltaValve™ transcatheter mitral valve replacement (TMVR) device developed by 4C Medical Technologies, Inc. have been published, showing promising outcomes for high-risk patients with symptomatic severe mitral regurgitation (MR) [1] Group 1: Study Results - The study included 30 high-risk patients across Europe, the United States, and Japan, with 13 patients undergoing the transapical approach and 17 patients undergoing the transseptal approach [1] - The procedural success rate was reported at 97%, with complete elimination of MR in all patients [1] - The mean transvalvular pressure gradient decreased from 2.5 mmHg at baseline to 2.1 mmHg post-procedure, indicating significant improvement in cardiac hemodynamics [1] - 96% of patients improved to NYHA functional class I-II after one year, reflecting a substantial enhancement in quality of life [1] Group 2: Safety and Mortality - The one-year all-cause mortality rate was 17% for the transapical group and only 7% for the transseptal group, with no cases of cardiac-related mortality [1] - There were no adverse events such as stroke, new-onset atrial fibrillation, or re-intervention on the mitral valve reported in the entire cohort [1] Group 3: Regulatory Approval - AltaValve™ received two breakthrough device designations from the FDA in 2024 and is currently conducting pivotal clinical studies in Europe and the United States under an FDA-approved Investigational Device Exemption (IDE) [2]

Core Insights - The early feasibility study results for the AltaValveTM transcatheter mitral valve replacement (TMVR) device developed by 4C Medical Technologies, Inc. have been published, showing promising outcomes in high-risk patients with symptomatic severe mitral regurgitation (MR) [1][2] Group 1: Study Results - The study included 30 patients across Europe, the United States, and Japan, all of whom were at high surgical risk and had symptomatic severe MR [1] - The technical success rate of the procedure was reported at 97%, with complete elimination of MR in all patients [1] - The mean transvalvular pressure gradient decreased from 2.5 mmHg at baseline to 2.1 mmHg post-procedure, indicating significant improvement in cardiac hemodynamics [1] Group 2: Safety and Outcomes - The one-year all-cause mortality rate was 17% for the transapical group and only 7% for the transseptal group, with no cases of cardiac-related mortality [1] - There were no adverse events such as stroke, new-onset atrial fibrillation, or re-intervention on the mitral valve reported in the entire cohort [1] - 96% of patients improved to NYHA functional class I-II at one year, reflecting a substantial enhancement in quality of life [1] Group 3: Regulatory Status - AltaValveTM has received two breakthrough device designations from the FDA in 2024 and is currently undergoing pivotal clinical studies in Europe and the United States under an FDA-approved Investigational Device Exemption (IDE) [2]

Core Viewpoint - MicroPort CardioFlow-B (02160) has announced significant growth in its VitaFow® transcatheter aortic valve and delivery system, with a cumulative implantation of nearly 1,300 cases across 35 countries and regions as of the announcement date [1] Group 1: Market Expansion - The company expects the implantation volume to exceed 850 cases in 2025, representing an increase of nearly 350% compared to 2024 [1] - In the second half of 2025, the implantation volume is projected to grow by over 170% compared to the first half, driven by the commercialization of VitaFow Liberty® in European countries following CE certification and increased market share in emerging markets in Asia and Latin America [1] Group 2: Strategic Development - The board believes that the recent acquisition of MicroPort Cardiac Rhythm Management will enhance local channel resources and clinical support systems in mature markets like Europe, significantly improving market access efficiency for TAVI products [1] - The company aims to continuously leverage the synergies from business integration, advancing the research and clinical progress of next-generation TAVI products, and enhancing its comprehensive competitiveness in the global valve treatment field [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 本公告乃由微創心通醫療科技有限公司（「本公司」，連同其附屬公司統稱「本 集團」）自願作出，以知會本公司股東及潛在投資者有關本集團最新業務進展。 本公司董事「( 董 事」)會（「董事會」）欣 然 宣 佈， 截 至 本 公 告 之 日， 本 集 團 VitaFow®系列經導管主動脈瓣膜及輸送系統（「TAVI」）已進入全球35個國家及地 區，累計植入量近1,300例。其中，2025年植入量預計將超過850例，較2024年增 長近350%。2025年下半年，得益於VitaFow Liberty®獲得CE證後在歐洲國家商業 化的持續拓展，以及在亞洲和拉美新興市場國家份額的持續提升，植入量較上 半年增長超過170%。 – 1 – 本公司董事會相信，通過近期完成的併購微創心律管理的交易，本集團將進一 步強化在歐洲等成熟市場的本地化渠道資源與臨床支持體系，顯著提升TAVI 產品的新市場准入效率與既有市場的滲透深度。未來 ...

（ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：2160） 自願公告 AltaValveTM早期可行性研究一年隨訪結果正式公佈 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 MicroPort CardioFlow Medtech Corporation 微創心通醫療科技有限公司 本公告乃由微創心通醫療科技有限公司（「本公司」，連同其附屬公司統稱「本 集團」）自願作出，以知會本公司股東及潛在投資者有關本集團最新業務進展。 本 公 司 董 事（「董 事」）會（「董事會」）欣 然 宣 佈，近 日，由 集 團 聯 營 公 司 4C Medical Technologies, Inc.（「4C Medical」）自主研發的AltaValveTM經導管二尖瓣置 換（「TMVR」）醫療器械（「AltaValveTM」）的早期可行性研究一年隨訪結果正式公 佈。 本次研究覆蓋歐洲、美國、日本多中心，納入患者30名，均為手術高風險、 伴有 ...

Mergers and Acquisitions - Yilong Co. plans to acquire 51% stake in Wenkong Salt Lake from its controlling shareholder for a cash consideration of 4.605 billion yuan, making Wenkong Salt Lake a subsidiary and included in the consolidated financial statements [1] - Shengxin Lithium Energy intends to acquire 30% stake in Qicheng Mining for 2.08 billion yuan, which will result in 100% ownership of Qicheng Mining, enhancing control over Huirong Mining, known for its high-grade lithium mine with an annual production capacity of 3 million tons [2] - Mingde Bio plans to acquire 100% stake in Wuhan Bikaier Rescue Supplies for cash, which is expected to constitute a major asset restructuring [3] - CITIC Special Steel's wholly-owned subsidiary plans to acquire 100% stake in Fujing Special for 1.51 billion yuan, which will support the company's global strategy and optimize its industrial chain [4] Shareholding Changes - Su Shi Testing's controlling shareholder plans to reduce its stake by up to 2%, equating to a maximum of 10.17 million shares, representing 6.26% of its holdings [5] - Hongxun Technology's controlling shareholder intends to reduce its stake by up to 3%, totaling a maximum of 1.21266 million shares through various methods [6] - Youbuxun's controlling shareholder and its concerted action party plan to reduce their combined stake by up to 2.96%, amounting to a maximum of 950.22 million shares [7]

近日， 北京尔瑞鑫悦科技有限公司 （以下简称"尔瑞鑫悦"）宣布完成新一轮 近亿元 A轮战略融资 。 本轮融资由 国中资本 领投， 成都思佰益基金 参与投资。此次融资为公司近四年来的第四轮增资，资 金将主要用于产能布局、平台技术升级及外泌体相关产品的临床与商业化推进。 在体外诊断与精准医疗持续向 "更早期、更微量、更无创" 方向演进的背景下，外泌体作为重要的信息 载体，其在复杂疾病诊断中的应用价值正在逐步被验证。尔瑞鑫悦本轮融资，反映出资本市场对外泌体 从科研工具走向临床产品阶段的持续关注。 # 围绕外泌体构建的平台型技术路径 从产业逻辑来看 ，外泌体的商业化难点并不只在于发现新的生物学意义，更在于如何在复杂样本中实现 稳定、可重复的提取与检测，这也是行业长期面临的工程化与标准化挑战。 在诊断应用方面， 尔瑞鑫悦已围绕神经系统疾病开展产品布局。公司基于脑源性外泌体靶向富集技术， 开发了用于检测血浆神经元外泌体中 α-突触核蛋白的体外诊断试剂盒，并已完成注册审批。该类产品 尝试通过外周血实现对中枢神经系统相关标志物的检测，切入帕金森病等神经退行性疾病的早期辅助诊 断场景。 从行业视角看， 这一方向代表着外泌体技术 ...

Core Viewpoint - The appointment of Dr. Charles Hugh-Jones as Global Chief Medical Officer of Fresenius Medical Care signals a shift in the dialysis and kidney care industry, where competition is moving from "equipment performance" to "medical systems and long-term efficacy management" [2]. Group 1: Fresenius Medical Care's Role - Fresenius Medical Care is not just a device manufacturer but provides a comprehensive life support system for chronic kidney disease patients, covering dialysis equipment, consumables, and service networks [3][4]. - The company's responsibilities extend beyond merely selling equipment to hospitals; it must maintain high stability in long-term safety, treatment consistency, and care quality [4]. Group 2: Transition from Maddux to Hugh-Jones - Dr. Franklin W. Maddux, who served as Global Chief Medical Officer since 2020, oversaw a period where the dialysis industry increasingly emphasized real-world evidence, long-term follow-up, and clinical quality management [5][7]. - Dr. Hugh-Jones brings a diverse background from Allergan, Pfizer, and Sanofi, aligning with a trend where chronic disease management is integrating broader medical strategies and data systems [9]. Group 3: Why "Medical Leadership" is Being Highlighted - The technological ceiling for dialysis devices is approaching, with differentiation increasingly based on long-term complication management, patient quality of life, and systemic care capabilities rather than single-treatment outcomes [11]. - Regulatory and payment systems are demanding clearer evidence of "clinical value," transforming the medical department from a compliance supporter to a builder of evidence systems [12]. - Data and services are reshaping the boundaries of device companies, pushing dialysis from "standardized device treatment" to "continuous medical services," necessitating deeper integration of medical decision-making into product and system design [13][14]. Group 4: Implications for the Medical Device Industry - The appointment of Hugh-Jones reflects a broader industry trend where medical functions are gaining strategic importance, especially in chronic disease management and long-term life support systems [15]. - Companies are increasingly recognizing that when product lifecycles span years, medical judgment becomes a critical component of product competitiveness [16].