本次突破性医疗器械认定产品，是美国FDA历史上全球首个颅内动脉粥样硬化狭窄治疗产品，同时也是 首个获得美国FDA突破性医疗器械认定的国产神经介入器械产品。本次认定的获得，是公司在神经介入 缺血性卒中治疗创新产品战略进程的又一重大里程碑，标志着公司在研产品COMETIU自膨式颅内药物 涂层支架系统的技术创新及显著临床优势进一步获得国际权威监管机构认可，该产品填补全球颅内动脉 粥样硬化狭窄治疗的空白，作为突破性医疗技术将为全球数百万脑卒中患者带来新的康复希望。 智通财经APP讯，赛诺医疗(688108.SH)发布公告，公司控股子公司赛诺神畅医疗科技有限公司(简称"赛 诺神畅")于近日收到美国食品药品监督管理局(简称"FDA")通知，公司控股子公司赛诺神畅自主研发的 COMETIU自膨式颅内药物涂层支架系统(简称"COMETIU支架")及COMEX球囊微导管获得美国FDA突 破性医疗器械认定。 本次认定的获得，将有力推动公司神经介入创新产品的国际化布局，加速公司全球化战略进程，显著提 升公司品牌的国际知名度，进一步夯实公司的核心竞争力。 ...

赛诺医疗公告，控股子公司赛诺神畅研发的COMETIU自膨式颅内药物涂层支架系统及COMEX球囊微 导管已获得美国FDA突破性医疗器械认定。该产品是美国FDA历史上全球首个颅内动脉粥样硬化狭窄治 疗产品，也是首个获得美国FDA突破性医疗器械认定的国产神经介入器械产品。此次认定的获得，是公 司在神经介入缺血性卒中治疗创新产品战略进程的又一重大里程碑，标志着公司在研产品COMETIU自 膨式颅内药物涂层支架系统的技术创新及显著临床优势进一步获得国际权威监管机构认可。同时，该认 定将有力推动公司神经介入创新产品的国际化布局，加速公司全球化战略进程，显著提升公司品牌的国 际知名度，进一步夯实公司的核心竞争力。 ...

在eLum的实验室里，Quang曾用一个简单实验展示技术突破：Quang左手拿起像精密弹簧一样的密网支 架，右手将杯子中的水倒入支架，倒进去的水没有像我们想像中的从支架中漏出来。Quang又拿起一支 铅笔轻轻碰触支架，这时有水漏出来了。这种特性，让支架既能阻断动脉瘤血流使其萎缩，又不影响周 边细小血管供血。 更关键的是，eLum帮助改进后的AUCURA血流导向密网支架可通过0.017"微导管抵达更深、更小的血 管中，且能100%顺利打开，这一性能同类产品很难做到。 技术优势源于材料与工艺的双重创新。AUCURA采用了新型合金材料，使用赛诺独有的电子涂层接枝 技术和编制技术，拥有全球最小的通过外径，能够在X光下实现全显影，具有更优的支架贴壁及更高效 封闭血管瘤能力，临床应用更加安全。而eLum并未止步于此，目前正针对支架显影不佳的行业通病， 研发全新的合金材料，未来有望让支架显影更好、支撑力更强。 宣武医院神经外科副主任何川在2025东方脑血管病会议上曾评价，该支架为远端动脉瘤提供了更安全到 达、更高效愈合、更可靠防护的解决方案，有望开启动脉瘤密网治疗的远近双轨时代。 从技术到产能的协同，是赛诺医疗快速崛起的关 ...

Summary of Key Points from the Conference Call Company Overview - **Company**: 新为医疗 (New Medical) - **Industry**: Neurointervention and Brain-Computer Interface (BCI) Core Insights and Arguments 1. **Product Development**: New Medical's invasive brain-computer interface (BCI) collects brain signals via intravascular electrode stents, with plans to start small-scale exploratory clinical trials by the end of 2026, primarily for post-stroke motor function recovery [2][3][5] 2. **Market Potential**: Approximately 1.5 to 2 million new stroke cases occur annually in China, with an estimated 4 to 5 million patients needing rehabilitation training in the next three years, representing a significant potential user base for BCI products [2][5] 3. **Technical Advantages**: The invasive BCI technology offers advantages over non-invasive methods, including less trauma and higher signal strength, although the precise wall-adhesion technology for electrode stents remains a key challenge [2][6] 4. **Financial Projections**: For the first half of 2025, the company expects profits of 15 to 18 million, with a full-year target of 30 million and revenue goals of 380 million, aiming for a long-term gross margin of 65% and a net margin of 15% to 20% [2][20] 5. **Strategic Planning**: The company aims to achieve profitability by 2025, with annual revenue growth of 30% over the next three to five years, leveraging collective procurement and product launches to capture market share [4][27] Additional Important Insights 1. **Clinical Research and Collaboration**: New Medical has partnered with Nankai University for clinical applications in stroke recovery, focusing on motor function restoration [5][18] 2. **Regulatory Environment**: The company is closely monitoring policy developments from regulatory bodies to facilitate product registration and inclusion in medical insurance reimbursement systems [10][12] 3. **Market Expansion**: New Medical is actively pursuing overseas market expansion, currently limited by FDA and EU certification processes [15][21] 4. **Product Pipeline**: The company plans to submit for regulatory review of its self-expanding drug-eluting stent by Q4 2025, with expectations for approval within a year [17] 5. **Industry Trends**: The collective procurement policy has significantly increased the market share of domestic neurointervention products, with projected growth in ischemic and hemorrhagic surgery volumes of 15%-20% and 10%-15%, respectively, in 2025 [4][22] Conclusion - New Medical is positioned to capitalize on the growing demand for neurointervention and BCI technologies, with a robust product pipeline and strategic partnerships aimed at enhancing recovery for stroke patients. The company is focused on achieving profitability and expanding its market presence while navigating regulatory challenges and industry dynamics.

Core Viewpoint - Maipu Medical plans to acquire 100% equity of Yijie Medical through a combination of share issuance and cash payment, aiming to expand its product offerings in the neurointerventional medical device market [1][2]. Group 1: Company Overview - Maipu Medical specializes in developing high-performance implantable medical devices using advanced manufacturing technology, covering key products needed for craniotomy surgeries [1]. - Yijie Medical focuses on the research, design, and sales of neurointerventional medical devices, including neurointerventional catheters and balloon dilation catheters [1]. Group 2: Market Potential - The neurovascular interventional medical device market in China grew from 3.2 billion yuan in 2017 to 6.7 billion yuan in 2022, with a compound annual growth rate (CAGR) of 15.7% [2]. - It is projected that the market size will reach 43.2 billion yuan by 2028, with a CAGR of 36.5% [2]. Group 3: Financial Performance and Challenges - Yijie Medical is expected to generate revenues of 11.94 million yuan and 24.41 million yuan in 2023 and 2024, respectively, but will incur net losses of 29.51 million yuan and 26.16 million yuan [3]. - The company faces significant challenges due to market competition and regulatory pressures, which may adversely affect its operations if strategic adjustments are not made [3]. Group 4: Market Reaction - Following the announcement of the acquisition, Maipu Medical's stock price fell by 8.31% to 58.25 yuan per share after resuming trading [4].

2025年4月18日，第二十二届脑血管病论坛（CFCVD2025）圆满召开，艾柯医疗"045密网护卫技术"发 布会暨机械球囊密网支架治疗复杂动脉瘤病例大师论坛"学术如火如荼进行。本次学术专题会聚焦于创 新通路技术的应用，深度探讨复杂病例中密网支架的临床应用，与会专家们共同绘制神经介入领域的新 蓝图，为推动该领域的学术发展和技术进步贡献智慧。 开场致辞 推陈致新，共同推进脑血管介入治疗精准化 大会主席张鸿祺教授表示，自密网支架进入血流导向治疗领域以来，我们见证了艾柯医疗所带来的创新 产品在临床实践中展现出的独特优势；搭配最新的导管加持，密网释放也变得更为简易。当前市场上涌 现的各类密网支架产品，始终遵循着"临床需求驱动技术革新"的发展规律。艾柯医疗在保持自身核心竞 争力的同时，持续推出各项技术，使神经介入手术更容易、更普及、更精准，未来与各位携手，神经介 入与介入技术持续突破，共同推进脑血管介入治疗的精准化进程。 注：图为学术会现场 注：张鸿祺，首都医科大学宣武医院 PART I 045密网护卫技术治疗 复杂动脉瘤专场学术盛宴 通路革新，临床获益 Cosine45微中间管提供045密网护卫新选择！ 解决这些问题 ...

根据《证券期货投资者适当性管理办法》及配套指引，本资料仅面向华创证券客户中的金融机构专业投资者，请勿对本资料进行任何形式的转发。若您不是华创证券客户中的金融机构专业投资者，请勿订 阅、接收或使用本资料中的信息。 本资料难以设置访问权限，若给您造成不便，敬请谅解。感谢您的理解与配合。 摘要 神经+外周介入双引擎驱动，受益集采，布局海外。 公司在神经介入、外周介入产品线布局全面，截止2025/3/20，公司共战略布局66款产品及候选产 品，已在国内商业化产品共计47款。公司抓住集采机遇，推动产品放量，实现收入的强劲增长，2021-2024年收入CAGR达到131%，并在2024年实现扭 亏为盈，全年净利润为1亿元，截至2024年底，账上资金总额达到25亿元，充裕现金流为产品管线自研/并购、商业化拓展提供支持。2024年海外收入 2258万元，同比增长58.2%，海外拓展已初具规模，有望为公司贡献长期业绩增量。 神经 介入：渗透率、国产化率双 低赛道，公司以丰富产品组合拥抱集采 。 1）行业：渗透率、国产化率双低的高潜力赛道。 国内神介手术受众群体大，近些年手术渗透率快速提升，神经介入耗材市场规模同步快速增长，20 ...

Core Viewpoint - The company is leveraging dual engines of neuro and peripheral intervention, benefiting from centralized procurement and expanding overseas, with a projected revenue CAGR of 131% from 2021 to 2024, and a turnaround to profitability in 2024 with a net profit of 100 million yuan [2][15]. Group 1: Company Overview - The company, established in 2012, focuses on innovative research, manufacturing, and sales of medical devices in neuro and peripheral vascular intervention [3]. - It has developed a comprehensive product line covering all five categories of neurovascular intervention and a full range of peripheral vascular intervention products, positioning itself in the top tier of the domestic market [5]. Group 2: Market Potential and Growth - The neuro intervention market in China has low penetration and localization rates, with a 2023 penetration rate of 13.8% for hemorrhagic neuro intervention surgeries, compared to 65.3% in the US, indicating significant growth potential [30][39]. - The domestic neuro intervention consumables market has grown rapidly, with a CAGR of 16% from 2017 to 2022, reaching 6.68 billion yuan [37]. Group 3: Centralized Procurement Impact - Since 2021, centralized procurement has expanded in the neuro intervention sector, benefiting leading domestic manufacturers by increasing market penetration and localization rates [43]. - The average price reduction from centralized procurement has stimulated demand, leading to increased sales volumes that offset some of the negative impacts of price drops [45]. Group 4: Financial Performance - The company achieved a revenue of 783 million yuan in 2024, with a year-on-year growth of 48%, and a net profit of 100 million yuan, marking a return to profitability [15]. - The gross margin has remained relatively stable at 71.6% despite some price reductions due to centralized procurement, supported by improved operational efficiency and a decrease in expense ratios [18]. Group 5: Overseas Expansion - In 2024, the company generated 22.58 million yuan in overseas revenue, a 58.2% increase, with plans to expand into Europe and emerging markets in Asia, Africa, and Latin America [24]. - The company has already commercialized 20 products in 24 overseas countries, with 8 products receiving CE marks in Europe [29]. Group 6: Product Pipeline and Innovation - The company has a robust product pipeline with 66 strategic products and candidates, of which 47 are already commercialized, and expects 17 more to be approved between 2025 and 2027 [5][49]. - Upcoming products include a flow-directed stent and a drug-eluting self-expanding intracranial stent, which are anticipated to significantly contribute to revenue growth [52][53].

Group 1 - The core viewpoint of the news is that Aiko Medical showcased its innovative products in the neurointervention field at the 2025 Zhongguancun Forum, highlighting its advancements and contributions to the industry [1][2]. - Aiko Medical's Lattice flow-directed stent is noted for its wide application in treating small to medium-sized vertebral artery aneurysms, being the product with the largest approved indication range in its category [1][2]. - The Lattice stent utilizes cobalt-chromium alloy and features world-first technologies such as a mechanical balloon delivery system and MIROR surface modification, significantly reducing surgical difficulty and time while improving patient cure rates and safety [1][2]. Group 2 - Aiko Medical also introduced the Lattice NEXT "no-extension guidewire" flow-directed stent, expanding its application to adult patients with unruptured saccular or fusiform wide-neck aneurysms in the internal carotid and vertebral arteries [2]. - The company has received NMPA approval for eight products, filed 132 patents, with 73 granted, and its Lattice stent has been recognized as an "innovative medical device" by the National Medical Products Administration [2]. - Aiko Medical aims to provide comprehensive innovative solutions for global cerebrovascular disease patients and doctors, focusing on domestic production and addressing unmet clinical needs in the cerebrovascular disease field [2].

证券研究报告|医药生物|2025年3月15日 www.hczq.com ERA | 01 | 行情回顾 | | --- | --- | | 02 | 板块观点和投资组合 | | 03 | 行业和个股事件 | 神经介入行业近况更新 本周专题联系人：李婵娟 张良龙 | 华创医药团队: | | | --- | --- | | 首席分析师 郑辰 | 执业编号：S0360520110002 邮箱：zhengchen@hcyjs.com | | 联席首席分析师 刘浩 | 执业编号：S0360520120002 邮箱：liuhao@hcyjs.com | | 医疗器械组组长 李婵娟 | 执业编号：S0360520110004 邮箱：lichanjuan@hcyjs.com | | 中药和流通组组长 高初蕾 | 执业编号：S0360524070002 邮箱：gaochulei@hcyjs.com | | 分析师 万梦蝶 | 执业编号：S0360523080008 邮箱：wanmengdie@hcyjs.com | | 分析师 王宏雨 | 执业编号：S0360523080006 邮箱：wanghongyu@hcyjs.com ...