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。 根据《中华人民共和国公司法》（以下简称"《公司法》"）、《上市公司章 程指引》《上海证券交易所科创板股票上市规则》等法律法规、规范性文件以及 《北京佰仁医疗科技股份有限公司章程》（以下简称"《公司章程》"）的相关规 定，公司董事会成员中应包含 1 名职工董事。因公司内部治理结构调整，董事李丽 艳女士于近日辞去公司董事职务，其辞职后在公司继续担任副总经理、生产总监职 务。 公司于 2025 年 9 月 25 日在公司会议室召开 2025 年职工代表大会（以下简称 "本次职工代表大会"），审议通过了《关于选举公司第三届董事会职工代表董事 的议案》，同意选举李丽艳女士为公司第三届董事会职工代表董事，李丽艳女士的 简历详见本公告附件。 证券代码：688198 证券简称：佰仁医疗 公告编号：2025-034 北京佰仁医疗科技股份有限公司 关于董事调整暨选举第三届董事会职工代表董事的公告 北京佰仁医疗科技股份有限公司 第三届董事会职工代表董事候选人简历 李丽艳：女，1980 年出生，中国 ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 119.45 CNY based on DCF valuation method [3][5]. Core Insights - The company reported strong performance in H1 2025, achieving revenue of 250 million CNY, a year-on-year increase of 30.1%, and a net profit attributable to the parent company of 70 million CNY, up 102.9% year-on-year [9]. - The successful launch of the transcatheter aortic valve replacement (TAVR) system in August 2024 has expanded the product line and significantly boosted sales [9]. - The company maintains a high gross margin of 90.5% in Q2 2025, attributed to the introduction of new products and active academic promotion efforts [9]. Financial Performance Summary - Revenue is projected to grow from 371 million CNY in 2023 to 1,136 million CNY in 2027, with a compound annual growth rate (CAGR) of 26.5% [4]. - The net profit attributable to the parent company is expected to increase from 115 million CNY in 2023 to 346 million CNY in 2027, reflecting a CAGR of 29.3% [4]. - The earnings per share (EPS) are forecasted to rise from 0.84 CNY in 2023 to 2.51 CNY in 2027 [4]. Research and Development - The company invested 70 million CNY in R&D in H1 2025, accounting for 30% of revenue, with plans for 12 products to enter the registration review process, marking a record year for product registrations [9]. - Several products, including ocular biological patches and ePTFE pericardial membranes, are currently undergoing registration review, indicating a robust pipeline for future growth [9].

Core Insights - The company successfully launched its TAVR product, achieving revenue of 250 million yuan in H1 2025, a year-on-year increase of 30.1%, and a net profit attributable to shareholders of 70 million yuan, up 102.9% year-on-year, with a 64.7% increase after excluding share-based payment impacts [1] - The TAVR product has received broad market recognition and has been patented in Japan and registered in Indonesia, laying a solid foundation for international expansion [1] - The company maintains a high gross margin of 90.5% in Q2 2025, attributed to the new product launch, while actively promoting academic initiatives to enhance market presence [1] Financial Performance - In H1 2025, the company reported a gross margin of 90.5%, an increase of 1.2 percentage points year-on-year and 4.7 percentage points quarter-on-quarter [1] - The sales expense ratio, excluding share-based payment costs, remained stable at 24.0% in H1 2025 [1] Research and Development - The company invested 70 million yuan in R&D in H1 2025, accounting for 30.0% of revenue, with plans for 12 products to enter the registration review process by 2025, marking the highest number of products in review since its establishment [2] - Several products, including ophthalmic biological patches and ePTFE pericardium, have received feedback on their registration reviews, while others are in the clinical trial phase [2] Future Outlook - The company has adjusted its earnings per share forecasts for 2025-2027 to 1.43, 1.94, and 2.51 yuan respectively, with a target price of 119.45 yuan based on DCF valuation, maintaining a "buy" rating [2]

Core Viewpoint - The company, Baifen Medical, has announced that its self-developed radiofrequency ablation system has received approval from the National Medical Products Administration (NMPA) to enter the special review process for innovative medical devices [2] Group 1 - The radiofrequency ablation system is a product developed independently by the company [2] - The approval marks a significant step for the company in the medical device sector [2] - The entry into the special review process indicates the potential for expedited evaluation and market entry [2]

Core Viewpoint - The announcement indicates that Baifen Medical's self-developed radiofrequency ablation system has received approval from the National Medical Products Administration to enter the special review process for innovative medical devices [1] Group 1: Product Details - The radiofrequency ablation system consists of three products: an ablation instrument, an ablation forceps, and an ablation pen [1] - This system is specifically designed for the surgical treatment of persistent and permanent atrial fibrillation [1] Group 2: Technical Approach - The product is based on traditional maze surgery principles and employs an open-heart surgical method to electrically isolate cardiac tissue [1] - The system aims to create transmyocardial, continuous, and irreversible linear lesions to eliminate atrial fibrillation triggers and maintain the substrate, ultimately restoring sinus rhythm [1]

证券代码：688198 证券简称：佰仁医疗 公告编号：2025-033 北京佰仁医疗科技股份有限公司 关于自愿披露射频消融系统 申报产品名称：射频消融系统 受理号：CQTS2500225 产品管理类别：第三类 审查决定：同意按照《创新医疗器械特别审查程序》进行审查 二、产品情况介绍 该射频消融系统由消融仪、消融钳和消融笔三个产品组成，专用于心外科手术 治疗持续性、永久性房颤。该产品是按照传统迷宫手术原理，采用心外直视手术的 方式，对心房组织进行电隔离，即创建透壁、连续、不可逆的线性损伤，从而达到 消除房颤触发灶和维持基质，以达到恢复窦性心律的目的。 进入创新医疗器械特别审查程序的公告 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、准确性和完整性依法承担法律责任。 近日，北京佰仁医疗科技股份有限公司（以下简称"公司"）自主研发的射频 消融系统获国家药品监督管理局医疗器械技术审评中心同意，进入创新医疗器械特 别审查程序，现将具体情况公告如下： 一、基本信息 心外科传统治疗房颤是通过手术实施的。法国心外医生James Cox博士在1987年 设计了 "迷宫"手 ...

Core Viewpoint - The company, Bairen Medical (688198.SH), has received approval from the National Medical Products Administration for its self-developed radiofrequency ablation system, allowing it to enter the special review process for innovative medical devices [1] Group 1: Product Details - The radiofrequency ablation system consists of three products: an ablation instrument, an ablation clamp, and an ablation pen [1] - This system is specifically designed for the surgical treatment of persistent and permanent atrial fibrillation [1] Group 2: Technology and Mechanism - The product is based on the traditional maze surgery principle and employs an open-heart surgical approach to electrically isolate atrial tissue [1] - It creates a trans-wall, continuous, and irreversible linear lesion to eliminate the triggers of atrial fibrillation and maintain the substrate, aiming to restore sinus rhythm [1]

佰仁医疗公告，公司自主研发的射频消融系统获国家药品监督管理局医疗器械技术审评中心同意，进入 创新医疗器械特别审查程序。该射频消融系统由消融仪、消融钳和消融笔三个产品组成，专用于心外科 手术治疗持续性、永久性房颤。该产品采用直视下外科消融，具有显著的临床优势，有望提高患者术后 生活质量。进入创新医疗器械特别审查程序将有助于缩短产品的注册周期，但注册上市仍需提交注册申 请并经国家药品监督管理局批准。 ...

内容概要：人工硬脑膜是用生物材料制成人体脑膜的替代物，用于因颅脑、脊髓损伤、肿瘤及其他颅脑 疾病引起的硬脑膜或脊膜缺损的修补，防止脑脊液外漏、颅内感染、脑膨出、脑粘连和疤痕等严重并发 症，以恢复其完整性。人工硬脑膜属于植介入耗材，伴随着国民可支配收入增加、老龄化程度加深，脑 血管疾病发病率上升，神经外科介入类手术需求增加，推动人工硬脑膜的需求放量增长。但2021年以来 随着集采的稳步推进，国内人工硬脑膜产品价格下降较为明显。2024年，我国人工硬脑膜需求量从2017 年的44.63万片增长至94.61万片，产品价格从2017年的1775元/片下降至800元/片，人工硬脑膜市场规模 则从2020年的10.26亿元下降至2024年的7.57亿元。 关键词：人工硬脑膜行业政策、人工硬脑膜产业链、人工硬脑膜需求量、人工硬脑膜行业均价、人工硬 脑膜市场规模、人工硬脑膜市场竞争格局、人工硬脑膜行业发展趋势 一、人工硬脑膜行业基本概况 神经外科作为医学领域最为复杂的学科之一，是以手术为主要手段，医治中枢神经系统（脑、脊髓）、 周围神经系统和植物神经系统疾病的一门临床外科专科。作为高精尖的前沿学科之一，神经外科对应用 在手术 ...

上海君澜律师事务所 关于北京佰仁医疗科技股份有限公司 2025 年第一次临时股东大会的法律意见书 致：北京佰仁医疗科技股份有限公司 根据《中华人民共和国公司法》（以下简称"《公司法》"）、《中华人民 共和国证券法》《上市公司股东会规则》（以下简称"《股东会规则》"）等法 律、法规、规章、规范性文件及《北京佰仁医疗科技股份有限公司章程》（以下 简称"《公司章程》"）的规定，上海君澜律师事务所（以下简称"本所"）接 受北京佰仁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 出席公司2025年第一次临时股东大会（以下简称"本次股东大会"），并就本次 股东大会的召集、召开程序及表决程序、表决结果等事项出具本法律意见书。 本法律意见书仅供本次股东大会之目的使用。本所律师同意将本法律意见书 随公司本次股东大会其他信息披露资料一并公告。 本所律师按照律师行业公认的业务标准、道德规范和勤勉尽责的精神，对本 次股东大会所涉及的有关事项和相关文件进行了必要的核查和验证，现出具法律 意见如下： 公司董事会于 2025 年 8 月 28 日在《中国证券报》《上海证券报》《证券 时报》《证券日报》以及上海证券交易所网站（ ...