证券研究报告 医药生物 | 医疗器械 非金融|公司点评报告 hyzqdatemark 2025 年 12 月 01 日 证券分析师 刘闯 SAC：S1350524030002 liuchuang@huayuanstock.com 林海霖 SAC：S1350524050002 linhailin@huayuanstock.com 市场表现： 请务必仔细阅读正文之后的评级说明和重要声明 事件：公司发布公告，一次性使用压力导管(PFA 导管)获得国内药品监督管理局注册 申请，产品矩阵持续丰富。 联系人 海外营收稳步增长，扣非归母净利润扭亏。2025 年前三季度，公司实现营业收入 3.36 亿元（yoy+15.65%），归母净利润 0.42 亿元（yoy+0.46%），扣非归母净利润 0.24 亿元。第三季度，营业收入 1.13 亿元（yoy+21.78%），归母净利润 0.09 亿元 （yoy-62.56%），扣非归母净利润 0.03 亿元，同比扭亏为盈。前三季度海外市场中 拉美、欧洲、中东及非洲，收入均保持较高增长态势，冷冻全套产品于 25Q2 获得 CE 认证，已在部分海外市场启动推广。 创新医疗器械获批，电生 ...

Core Insights - In 2025, Microelectrophysiology achieved its first comprehensive profit in Q3, driven by its main business after successfully commercializing the three major energy platforms of "Ice, Fire, and Electricity" [1] - The company reported a revenue of 336 million yuan for the first three quarters, a year-on-year increase of 15.65%, and a net profit attributable to shareholders of 41.92 million yuan, with a slight increase of 0.46% year-on-year [1] - The company has established a complete product layout with over 30 products in the cardiac electrophysiology field, focusing on four major technical paths [1] Financial Performance - For Q3, the company achieved a revenue growth of 21.78% year-on-year, indicating a positive trend [1] - The net profit attributable to shareholders after deducting non-recurring gains reached 3.26 million yuan in Q3, marking a turnaround from losses [1] - The company’s net profit excluding non-recurring items for the first three quarters was 24.07 million yuan, indicating a return to profitability [1] Market Dynamics - The domestic electrophysiology device market is expected to reach 15.73 billion yuan by 2025, driven by an aging population and increasing prevalence of arrhythmias [2] - The company is responding to national procurement policies, which have strengthened its market share and clinical application opportunities [2] - Microelectrophysiology has covered over 1,000 hospitals with its three-dimensional electrophysiology surgeries, completing over 80,000 procedures, ranking first among domestic manufacturers [2] Technological Advancements - The company has made significant breakthroughs in high-end catheter products, including the successful completion of the first Magbot robotic navigation surgeries in February 2025 [3] - High-end products like pressure ablation catheters have been used in over 3,000 surgeries across multiple medical centers, contributing to market share growth [3] - The company is advancing in the PFA (Pulsed Field Ablation) field, with new products entering the market and gaining regulatory approval [4] Strategic Expansion - Microelectrophysiology is expanding its international presence, with three-dimensional surgeries covering over 20 countries and a revenue growth rate exceeding 40% in overseas markets [5] - The company has nine innovative products in the special approval process for national innovative medical devices, with five already approved [5] - The company aims to leverage both domestic and international markets to enhance its competitive edge in high-end arrhythmia procedures [5][6]

Core Insights - The company reported a revenue of 224 million yuan for the first half of 2025, representing a year-on-year growth of 12.80% [1] - The net profit attributable to shareholders reached 32.67 million yuan, with a significant year-on-year increase of 92.02% [1] - The company has seen a substantial rise in its non-recurring net profit, which grew by 2157.44% to 20.81 million yuan [1] Financial Performance - In Q2 2025, the company achieved a revenue of 120 million yuan, marking a year-on-year growth of 9.56% [1] - The net profit for Q2 was 14.80 million yuan, reflecting a year-on-year increase of 15.22% [1] - The non-recurring net profit for Q2 was 8.25 million yuan, with a remarkable growth of 262.86% [1] - The overall gross margin for the first half of 2025 was 60.10%, with a net profit margin of 14.60%, up by 6.02 percentage points year-on-year [2] Product Development and Market Expansion - The company has expanded its three-dimensional electrophysiology surgery to over 1,000 hospitals, completing more than 80,000 surgeries, ranking first among domestic manufacturers [1] - The clinical acceptance of the disposable pressure monitoring magnetic positioning radiofrequency ablation catheter continues to rise, with over 3,000 procedures completed [1] - The company has received NMPA approval for its disposable magnetic positioning pressure monitoring radiofrequency ablation catheter, enhancing its clinical application [1] - The company is actively expanding into overseas markets, with three-dimensional surgeries being implemented in over 20 countries, including successful cases in Germany and Azerbaijan [2] - The IceMagic? cryoablation product line has received CE certification and is now being promoted in European markets [2] Cost Structure and Profitability - The company has optimized its cost structure, with sales expense ratio at 28.13%, management expense ratio at 9.28%, and R&D expense ratio at 13.71% [2] - The financial expense ratio was reported at -1.76%, indicating a favorable cost environment [2] Future Outlook - The company has adjusted its revenue forecasts for 2025-2027 to 472 million, 617 million, and 809 million yuan, with respective growth rates of 14%, 31%, and 31% [2] - The net profit forecasts for the same period are set at 79 million, 103 million, and 133 million yuan, with growth rates of 51%, 31%, and 29% respectively [2] - The company maintains a "strongly recommended" rating despite short-term disruptions in revenue growth due to external industry factors [2]

Core Insights - The article highlights the upcoming global medical technology conferences and recent approvals of innovative medical devices in China, emphasizing the growth and innovation in the medical technology sector [1][13]. Group 1: Medical Device Approvals - On June 27, 2025, three innovative medical devices received approval from the National Medical Products Administration of China, including a spinal surgery navigation device, a cardiac pulsed electric field ablation device, and a biodegradable magnesium alloy screw [1][2]. - As of now, a total of 360 innovative medical devices have been approved for market in China [1]. Group 2: Spinal Surgery Navigation Device - The spinal surgery navigation device from China-Europe Zhihui (Shanghai) Robot Co., Ltd. is the first in China to utilize micro robotic arm technology, allowing for precise spatial positioning during adult spinal surgeries [3]. - This device significantly reduces the space occupied in the operating room compared to traditional multi-axis robotic arms, enhancing safety and efficiency [3]. Group 3: Cardiac Pulsed Electric Field Ablation Device - The cardiac pulsed electric field ablation device from Shenzhen Maiwei Medical Technology Co., Ltd. is designed for treating drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation [8]. - It is the first device to use nanosecond pulse width high-voltage electric fields for pulmonary vein isolation, providing real-time monitoring and feedback during the ablation process [8]. Group 4: Biodegradable Magnesium Alloy Screw - The biodegradable magnesium alloy screw from Syntellix AG is made from a magnesium-based alloy and is designed to gradually degrade and be replaced by endogenous new tissue within the body [11][12]. - Compared to traditional titanium or steel implants, this product claims to reduce surgical time, costs, pain, and infection risks by half [12].

Investment Rating - The report maintains a "Strong Buy" rating for the company [3] Core Views - The company reported Q1 2025 revenue of 104 million yuan, a year-on-year increase of 16.77%, and a net profit of 17.87 million yuan, up 328.63% [1] - The approval of the PFA product is expected to significantly open up the atrial fibrillation market, with ongoing efforts to enhance the product line [6] - The company anticipates revenue growth of 28%, 31%, and 30% for 2025, 2026, and 2027, respectively, with net profit growth of 51%, 35%, and 34% [6] Financial Data and Valuation - Total revenue projections for 2023 to 2027 are 329 million, 413 million, 530 million, 696 million, and 902 million yuan, respectively, with year-on-year growth rates of 26%, 26%, 28%, 31%, and 30% [2][9] - The company expects operating profit to grow significantly, with projections of 8 million, 55 million, 81 million, 109 million, and 145 million yuan from 2023 to 2027, reflecting growth rates of 153%, 613%, 49%, 34%, and 33% [2][9] - The projected earnings per share (EPS) for 2025 is 0.17 yuan, with a price-to-earnings (PE) ratio of 129.1 [2][9] Key Financial Ratios - The gross margin for Q1 2025 was reported at 60.56%, with a net profit margin of 17.17% [6] - The return on equity (ROE) is projected to increase from 3.0% in 2024 to 7.1% in 2027 [9] - The company's asset-liability ratio is low, projected at 8.0% for 2025 [9]

报名：首届全球眼科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 报名：首届全球骨科大会 | 奖项评选 合作伙伴征集：2025全球手术机器人大会 2025年4月1日，国家药品监督管理局批准了 上海商阳医疗科技有限公司 的 "心脏脉冲电场消融设备" （ 国械注准20253010702）和 "一次性使用磁电定位心脏 脉冲电场消融导管" （ 国械注准20253010703），以及 天津市鹰泰利安康医疗科技有限责任公司 的 "心脏脉冲电场消融仪" （ 国械注准20253010705）和 "一 次性使用心脏脉冲电场消融导管" （ 国械注准20253010704） 创新产品注册申请。 截至目前，我国上市的创新医疗器械累计 338项 。 | 索引号 | XZXK-2025-174 主题分类 | | --- | --- | | 标题 | 心脏脉冲电场消融设备和一次性使用磁电定位心脏脉冲电场消融导管创新产品获批上市 | | 发布日期 | 2025-04-01 | 产品介绍 # 商阳医疗： "心脏脉冲电场消融设备"和"一次性使用磁电定位心脏脉冲电场消融导管" 产品介绍 心脏脉冲电场消融设备由 主机、电源线、脚踏开关、 ...