证券代码：688108 证券简称：赛诺医疗 公告编号：2025-053 赛诺医疗科学技术股份有限公司 本次投资者说明会以网络互动形式召开，公司将针对 2025 年第三季度的经营成果及财务 指标的具体情况与投资者进行互动交流和沟通，在信息披露允许的范围内就投资者普遍关注的 问题进行回答。 二、 说明会召开的时间、地点 三、 参加人员 董事长、总经理：孙箭华 会议召开时间：2025 年 11 月 17 日（星期一）14:00-15:00 会议召开地点：上海证券交易所上证路演中心（网址：https://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 关于召开 2025 年第三季度业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏， 并对其内容的真实性、准确性和完整性承担个别及连带责任。 重要内容提示： 投资者可于 2025 年 11 月 10 日（星期一）至 11 月 14 日（星期五）16:00 前登录上证路演中 心网站首页点击"提问预征集"栏目或通过公司邮箱 ir@sinomed.com 进行提问。公司将在说 明会上对投资者普遍关注 ...

Core Viewpoint - Sino Medical has been actively participating in the centralized procurement of neuro-interventional products across multiple regions in China since 2025, indicating a strategic move to enhance market presence and competitiveness in the industry [1] Group 1: Centralized Procurement Projects - Various regions in China, including Anhui, Hebei, Guangdong, Beijing, and Zhejiang, have initiated centralized procurement projects for neuro-interventional products [1] - Specific projects mentioned include the Anhui neuro-interventional stent volume-based procurement project, the Hebei-led four-category vascular interventional inter-provincial volume-based procurement project, and the Guangdong province mesh stent volume-based procurement project [1] - Sino Medical has successfully won bids for some of its neuro-interventional products in the procurement projects in Anhui, Hebei, and Guangdong [1] Group 2: Ongoing Procurement Activities - The centralized procurement activities in Beijing, Zhejiang, Hebei, and Guangdong are currently ongoing, suggesting a dynamic and evolving market environment for neuro-interventional products [1]

Core Viewpoint - Sino Medical (688108) has experienced a significant stock price decline of 25% this week, closing at 21.0 yuan, with a market capitalization of 8.737 billion yuan as of October 31, 2025 [1] Trading Information Summary - Sino Medical's stock price reached a peak of 28.82 yuan on October 27 and a low of 20.15 yuan on October 29, leading to its appearance on the stock exchange's "Dragon and Tiger List" due to a 15% drop in price [1][5] Shareholder Changes Summary - As of September 30, 2025, the number of shareholders for Sino Medical increased to 29,400, a rise of 164.74% compared to June 30, 2025, while the average number of shares held per shareholder decreased from 37,500 to 14,200 [2] Performance Disclosure Summary - For the first three quarters of 2025, Sino Medical reported revenue of 364 million yuan, a year-on-year increase of 14.24%, and a net profit attributable to shareholders of 21.118 million yuan, up 293.46%. The third quarter alone saw revenue of 123 million yuan, a 17.73% increase, and a net profit of 7.276 million yuan, reflecting a 150.51% growth [3][5] Company Announcement Summary - Sino Medical's subsidiary, COMETIU, did not receive approval from the National Medical Products Administration for its self-expanding intracranial drug-coated stent system. However, the product has passed the EU MDR quality system audit and is in the technical review stage. Additionally, the product received breakthrough device designation from the FDA and is set to initiate pivotal clinical studies [4] - The TRADENTTM coronary balloon dilation catheter has been approved by Korea's MFDS, expanding the company's product offerings in overseas markets [4]

Group 1 - The core point of the article is that Sino Medical announced on October 31 that as of September 30, 2025, the number of shareholders is 29,360 [1]

Group 1 - The core issue regarding the company's intracranial self-expanding drug-eluting stent registration application is that it was not approved due to the review department's concerns about the study design, which was deemed insufficient to evaluate the product's safety and efficacy [1] - The review department recommended conducting a randomized controlled study with the stent to address these concerns [1] - The company plans to maintain active and efficient communication with the regulatory agency to expedite the clinical and commercialization processes for the product both domestically and globally [1]

Group 1 - Sino Medical's TRADENT TM coronary stent balloon dilation catheter has received approval from the South Korean Ministry of Food and Drug Safety, obtaining a medical device registration certificate in South Korea [1] - The company's revenue composition for the year 2024 is projected to be 99.83% from the medical device industry and 0.17% from other businesses [2] - As of the latest report, Sino Medical's market capitalization stands at 8.7 billion yuan [3]

证券代码：688108 证券简称：赛诺医疗 公告编号：2025-052 赛诺医疗科学技术股份有限公司关于公司 棘突球囊产品获得国外医疗器械注册证的自愿性披露公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗 漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 有效期至：2030 年 10 月 28 日 二、医疗器械基本情况 本次获得韩国医疗器械注册证的 TRADENT TM冠状动脉棘突球囊扩张导管是公司自主研发并 在国内棘突球囊品类中最先获批的一款产品，主要用于 PTCA 中对于血管狭窄病变进行扩张治 疗。该产品在设计上兼顾了通过性、切割效果及安全性三大核心需求，采用棘突丝"螺旋式" 布局在球囊表面，使球囊具有强大嵌入能力的同时还具有较好的通过性。球囊充压后，能够有 效锁定钙化斑块并进行 360°全方位的斑块剥离，从而实现可控且高效的预处理。由于镍钛合 金具有形状记忆的优点，该产品在球囊卸压后，棘突丝仍能回缩变为原来的形状，更便于球囊 安全撤出冠状动脉血管。 与目前市场上的平行类斑块修饰球囊相比，相同规格型号下，"螺旋"棘突球囊体表面能 布局更多的棘突单元 ...

Core Viewpoint - Sino Medical's TRADENTTM coronary stent balloon dilation catheter has received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea, marking a significant advancement in the treatment of coronary artery stenosis [1][2] Group 1: Product Approval and Features - The TRADENTTM catheter is the first of its kind in the domestic market to receive approval, specifically designed for percutaneous transluminal coronary angioplasty (PTCA) to treat vascular stenosis [1] - The product features a spiral layout of thorn wires on the balloon surface, enhancing its embedding capability while maintaining good passability [1] - The balloon can effectively lock onto calcified plaques and perform 360° plaque stripping, allowing for controlled and efficient pre-treatment [1] Group 2: Clinical Benefits - The approval of the TRADENTTM catheter is expected to improve the shortcomings of conventional balloon dilation catheters, increasing the success rate of lesion dilation [2] - It aims to reduce the risk of complications such as vascular perforation and damage to normal vessel walls, providing physicians with more clinical options [2] - Patients are anticipated to benefit from enhanced clinical outcomes due to the improved design and functionality of the catheter [2]

Core Viewpoint - Sino Medical (688108.SH) has received approval from the Korean Ministry of Food and Drug Safety for its self-developed TRADENTTM coronary artery balloon dilation catheter, marking a significant milestone in its product portfolio expansion in overseas markets [1] Product Approval and Features - The TRADENTTM catheter is designed for the treatment of vascular stenosis during PTCA, featuring a unique "spiral" layout of thorn wires on the balloon surface, which enhances embedding capability while maintaining good passability [1] - Compared to existing plaque-modifying balloons in the market, this product offers more comprehensive plaque coverage and effectively reduces the incidence of dissection [1] Regulatory Approvals and Market Potential - The product has already obtained medical device registration certificates from the National Medical Products Administration of China, as well as from Thailand and Korea [1] - Following its launch in Korea, the product is expected to complement the company's coronary stents and balloons, potentially boosting overseas sales [1] Market Challenges - Sales in international markets may be influenced by uncertainties related to foreign regulations, market environment changes, and exchange rate fluctuations [1]

Core Viewpoint - Sino Medical (688108.SH) has received approval from the Korean Ministry of Food and Drug Safety (MFDS) for its TRADENT TM coronary stent balloon dilation catheter, enhancing its product offerings in overseas markets [1] Group 1: Product Approval - The TRADENT TM coronary stent balloon dilation catheter is designed for the dilation of narrowed coronary arteries [1] - The product has obtained a medical device registration certificate in South Korea, marking a significant milestone for the company [1] Group 2: Market Impact - The registration of the TRADENT TM catheter will effectively increase the variety of products available for sale in the overseas market [1] - Upon its launch in South Korea, the product will complement the company's existing offerings, such as coronary stents and balloons, creating a robust product portfolio [1] - The utilization of the company's overseas channel resources is expected to drive sales growth for its products in international markets [1]