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微电生理(688351) - 关于IceMagic?球囊型冷冻消融导管获得欧盟MDR认证的自愿性披露公告
2025-07-22 08:15
一、欧盟MDR认证证书的具体情况 证书编号:MDR 754792 R000 认证机构:BSI 证券代码:688351 证券简称:微电生理 公告编号:2025-014 上海微创电生理医疗科技股份有限公司 关于 IceMagic ®球囊型冷冻消融导管 获得欧盟 MDR 认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。 上海微创电生理医疗科技股份有限公司(以下简称"公司")冷冻系列产品 IceMagic®球囊型冷冻消融导管于近日获得了欧盟医疗器械法规(The Medical Device Regulations (EU) 2017/745,以下简称"MDR")认证证书,现将有关情 况公告如下: 1 促进公司"射频+冷冻"产品海外协同布局,不断提升公司在海外的品牌知名度, 对公司拓展海外市场带来积极影响。 上述产品在欧盟上市后,其国际市场销售可能会受到海外法规政策、市场环 境变化、汇率波动等不确定因素的影响,目前尚无法预测其对公司未来业务的具 体影响。敬请广大投资者谨慎投资,注意投资风险。 特此公告。 上海微创 ...
微电生理(688351) - 2025 Q2 - 季度业绩预告
2025-07-22 08:10
[Current Period Performance Forecast (2025 H1)](index=1&type=section&id=Item%201.%20Current%20Period%20Performance%20Forecast) The company forecasts 2025 H1 operating revenue between RMB 215 million and RMB 230 million, with net profit attributable to shareholders ranging from RMB 30 million to RMB 35 million, indicating substantial growth 2025 H1 Performance Forecast | Metric | Estimated Amount (RMB) | Year-on-Year Growth Rate (%) | | :--- | :--- | :--- | | **Operating Revenue** | 215.00 million - 230.00 million | 8.39 - 15.95 | | **Net Profit Attributable to Shareholders** | 30.00 million - 35.00 million | 76.34 - 105.73 | - The data contained in this performance forecast has not been audited by a certified public accountant[4](index=4&type=chunk) [Prior Period Performance (2024 H1)](index=1&type=section&id=Item%202.%20Prior%20Period%20Performance) In 2024 H1, the company reported operating revenue of RMB 198.36 million and net profit attributable to shareholders of RMB 17.01 million 2024 H1 Performance Overview | Metric | Amount (RMB) | | :--- | :--- | | **Operating Revenue** | 198.3646 million | | **Net Profit Attributable to Shareholders** | 17.0127 million | | **Net Profit Attributable to Shareholders (Excluding Non-Recurring Items)** | 0.9217 million | | **Total Profit** | 17.0327 million | | **Earnings Per Share** | 0.0362 | [Analysis of Performance Changes](index=2&type=section&id=Item%203.%20Analysis%20of%20Performance%20Changes) Performance growth is primarily driven by the company's focus on cardiac electrophysiology, strong overseas sales, and successful new product launches - The company's core strategy focuses on deep cultivation in the cardiac electrophysiology field, driven by globalization, leveraging a product matrix across 'ice, fire, electricity, and magnetic' technical pathways, primarily targeting the atrial fibrillation treatment market[8](index=8&type=chunk) - Excellent sales performance in overseas markets is a key factor for performance growth, attributed to the successful launch and promotion of products like the TrueForce® Pressure Monitoring RF Ablation Catheter and disposable star-shaped magnetic-electric mapping catheters abroad[8](index=8&type=chunk) - During the reporting period, the company's main business maintained a strong development trend, achieving steady growth in overall sales, which led to a significant year-on-year increase in net profit[8](index=8&type=chunk) [Risk Warning and Other Notes](index=2&type=section&id=Item%204.%20Risk%20Warning) The company confirms no major uncertainties affecting the forecast's accuracy but advises investors that the preliminary, unaudited data is subject to the final 2025 semi-annual report - The company states that there are no significant uncertainties affecting the accuracy of this performance forecast[9](index=9&type=chunk) - The company reminds investors that the forecast data is only preliminary, and the specific accurate financial data will be subject to the company's officially disclosed 2025 semi-annual report, urging caution regarding investment risks[10](index=10&type=chunk)
微电生理:预计2025年上半年净利润同比增长76.34%-105.73%
news flash· 2025-07-22 07:50
微电生理公告,预计2025年半年度实现归属于母公司所有者的净利润为3000万元到3500万元,与上年同 期相比,将增加1298.73万元到1798.73万元,同比增加76.34%到105.73%。报告期内,公司主营业务发 展态势良好,上半年整体销量实现稳步增长,带动公司净利润同比显著提升。 ...
微电生理收盘下跌1.06%,滚动市盈率140.53倍,总市值92.43亿元
Sou Hu Cai Jing· 2025-07-09 11:33
Group 1 - The core business of the company is the research, development, production, and sales of innovative medical devices in the field of electrophysiological interventional diagnosis and ablation treatment [2] - The company aims to provide globally competitive integrated solutions for diagnosis and ablation treatment, centered around precise interventional navigation [2] - The company has a range of products including the Columbus 3D cardiac electrophysiology mapping system and various disposable catheters and ablation devices [2] Group 2 - As of the latest financial report for Q1 2025, the company achieved a revenue of 104 million yuan, representing a year-on-year increase of 16.77%, and a net profit of 17.87 million yuan, up 328.63% [3] - The company's gross profit margin stands at 60.56% [3] - The company's current price-to-earnings (PE) ratio is 140.53, significantly higher than the industry average of 51.36 [3]
7月7日汇添富医疗服务灵活配置混合A净值下跌2.26%,近1个月累计上涨0.35%
Sou Hu Cai Jing· 2025-07-07 11:58
金融界2025年7月7日消息,汇添富医疗服务灵活配置混合A(001417) 最新净值1.7320元,下跌2.26%。该 基金近1个月收益率0.35%,同类排名1209|2349;近6个月收益率49.18%,同类排名3|2317;今年来收益 率43.85%,同类排名4|2315。 来源:金融界 汇添富医疗服务灵活配置混合A股票持仓前十占比合计64.17%,分别为:恒瑞医药(10.23%)、科伦药 业(9.09%)、百利天恒(8.94%)、海思科(8.27%)、信立泰(6.66%)、泽璟制药-U(6.10%)、新 诺威(4.69%)、荣昌生物(3.49%)、诺诚健华-U(3.35%)、微电生理(3.35%)。 公开资料显示,汇添富医疗服务灵活配置混合A基金成立于2015年6月18日,截至2025年3月31日,汇添 富医疗服务灵活配置混合A规模44.08亿元,基金经理为张韡。 简历显示:张韡女士:中国。康奈尔大学生物医学硕士,曾任东方证券医药助理研究员,汇添富基金医药研 究员、高级医药研究员及医药行业研究组组长。2021年3月25日至今任汇添富健康生活一年持有期混合 型证券投资基金的基金经理。2021年9月29日至 ...
微电生理:资本赋能 竞逐全球电生理市场
Core Viewpoint - The company, Microelectrophysiology, is leveraging capital to accelerate innovation and expand its market share in response to national procurement policies, aiming for a global market presence [1][2]. Group 1: Capital and Innovation - The successful listing on the Sci-Tech Innovation Board in August 2022 has provided strong development momentum for the company, allowing it to maintain strategic focus in high-investment, long-cycle innovation [1]. - The company plans to allocate nearly 25% of its revenue to R&D in 2024, positioning it as a leader in the industry [1]. - The capital injection has enhanced the company's resource integration capabilities, improving its supply chain management and international cooperation [2]. Group 2: Market Dynamics and Performance - From 2022 to 2024, the company's revenue is projected to grow from 260 million to 413 million, with net profit turning from a loss of 11.29 million to a profit of 5.08 million [2]. - The domestic electrophysiology device market is undergoing structural changes, with domestic companies like Microelectrophysiology increasing their market share against long-standing foreign competitors [2][3]. Group 3: Technological Advancements - The company has achieved a significant leap in technological capabilities, moving from a follower to a competitor on par with international giants in areas like three-dimensional mapping and magnetic electric positioning [3]. - The implementation of national procurement policies has accelerated the entry of products into clinical applications, enhancing the company's market reach [3]. Group 4: Global Expansion - The company is strategically focusing on the European market due to its large scale, strong insurance payment capabilities, and relatively fair competition environment [5]. - Emerging markets in Asia-Pacific, Latin America, and the Middle East are also targeted due to their high growth potential [5]. - The company acknowledges the challenges posed by complex market entry requirements and varying certification standards across different regions [5]. Group 5: Future Outlook - The company is optimistic about its international prospects, believing that advancements in technology and brand influence will enable it to capture a share of the global market [5]. - The dual pressures of international market expansion and intensified domestic competition are recognized, but the company is committed to continuous technological innovation and strengthening its entire industry chain [5].
微电生理收盘下跌1.16%,滚动市盈率140.81倍,总市值92.61亿元
Sou Hu Cai Jing· 2025-06-26 11:52
Company Overview - Shanghai Microelectrophysiology Medical Technology Co., Ltd. focuses on innovative medical devices in the field of electrophysiological interventional diagnosis and ablation treatment, aiming to provide globally competitive integrated solutions centered on precise interventional navigation [2] Product Portfolio - The main products include the Columbus 3D cardiac electrophysiology mapping system, EasyFinder 3D magnetic positioning adjustable mapping catheter, and various disposable mapping and ablation catheters [2] - The company’s cryoablation equipment and balloon-type cryoablation catheters have been approved for inclusion in the "2024 Shanghai Biomedical 'New Excellent Drugs and Devices' Product Directory" [2] - The fourth-generation 3D cardiac electrophysiology mapping system is also listed in the "2024 Shanghai Innovative Product Recommendation Directory" [2] Financial Performance - For Q1 2025, the company reported revenue of 104 million yuan, a year-on-year increase of 16.77%, and a net profit of 17.87 million yuan, reflecting a significant year-on-year growth of 328.63% [3] - The gross profit margin stands at 60.56% [3] Market Position - As of June 26, the company's stock closed at 19.68 yuan, with a rolling price-to-earnings (PE) ratio of 140.81, significantly higher than the industry average PE of 49.45 [1][3] - The total market capitalization is 9.261 billion yuan [1] Shareholder Information - As of March 31, 2025, the number of shareholders is 7,764, a decrease of 209 from the previous count, with an average holding value of 352,800 yuan per shareholder [1]
微电生理收盘上涨4.44%,滚动市盈率138.02倍,总市值90.78亿元
Sou Hu Cai Jing· 2025-06-23 11:55
上海微创电生理医疗科技股份有限公司的主营业务是电生理介入诊疗与消融治疗领域创新医疗器械研 发、生产和销售,致力于提供具备全球竞争力的"以精准介入导航为核心的诊断及消融治疗一体化解决 方案"。公司的主要产品是Columbus三维心脏电生理标测系统、EasyFinder3D磁定位型可调弯标测导 管、EasyLoop3D一次性使用磁定位环形标测导管、EasyLoop环肺静脉标测导管、EasyLoop一次性使用 心内标测电极导管、EasyFinder一次性使用可调弯标测导管、EasyFinder一次性使用固定弯标测导管、 EasyStars一次性使用星型磁电定位标测导管、FireMagicCool3D冷盐水灌注射频消融导管、FireMagic3D 磁定位型心脏射频消融导管、FireMagicPreciSense3D一次性使用磁定位微电极射频消融导管、 FireMagicTrueForce一次性使用压力监测磁定位射频消融导管等。公司冷冻消融设备、球囊型冷冻消融 导管、一次性使用压力监测磁定位射频消融导管凭借卓越性能与创新技术,获批纳入《2024年度上海市 生物医药"新优药械"产品目录》;同时,冷冻消融设备、球囊型冷冻消 ...
微电生理(688351) - 2024年年度股东大会决议公告
2025-06-18 12:15
证券代码:688351 证券简称:微电生理 公告编号:2025-012 上海微创电生理医疗科技股份有限公司 2024年年度股东大会决议公告 本公司董事会及全体董事保证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: 本次会议是否有被否决议案:无 一、 会议召开和出席情况 (一) 股东大会召开的时间:2025 年 6 月 18 日 | 1、出席会议的股东和代理人人数 | 85 | | --- | --- | | 普通股股东人数 | 85 | | 2、出席会议的股东所持有的表决权数量 | 371,096,329 | | 普通股股东所持有表决权数量 | 371,096,329 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 78.8559 | | 例(%) | | | 普通股股东所持有表决权数量占公司表决权数量的比例(%) | 78.8559 | (四) 表决方式是否符合《公司法》及公司章程的规定,大会主持情况等。 1 本次会议召开及表决方式符合《中华人民共和国公司法》(以下简称《公司 法》)及《上海微创电生理医疗科技股份 ...
微电生理(688351) - 北京世辉律师事务所关于上海微创电生理医疗科技股份有限公司2024年年度股东大会的法律意见书
2025-06-18 12:15
北京世辉律师事务所 关于上海微创电生理医疗科技股份有限公司 2024 年年度股东大会的 法律意见书 致:上海微创电生理医疗科技股份有限公司 北京世辉律师事务所(以下简称"本所")为具有从事法律业务资格的律师事 务所。本所接受上海微创电生理医疗科技股份有限公司(以下简称"公司")的委 托,指派本所律师根据《中华人民共和国公司法》《中华人民共和国证券法》(以 下简称"《证券法》")《上市公司股东会规则》等有关法律、法规、规范性文件 (以下统称"法律法规")及《上海微创电生理医疗科技股份有限公司章程》(以 下简称"《公司章程》")的规定,就公司 2024 年年度股东大会(以下简称"本次 股东大会")相关事宜出具本法律意见书。 本所及本所律师依据《证券法》《律师事务所从事证券法律业务管理办法》 和《律师事务所证券法律业务执业规则(试行)》等规定及本法律意见书出具日 以前已经发生或者存在的事实,严格履行了法定职责,遵循了勤勉尽责和诚实信 用原则,进行了充分的核查验证,保证本法律意见所认定的事实真实、准确、完 整,所发表的结论性意见合法、准确,不存在虚假记载、误导性陈述或者重大遗 漏,并承担相应法律责任。 为出具本法律意 ...