Investment Rating - The report maintains a "Buy" rating for the company, with projected PE ratios of 42, 34, and 27 for the years 2025, 2026, and 2027 respectively [4] Core Insights - The company is expected to achieve a revenue of 2.584 billion RMB in 2025, representing a year-on-year growth of 25%. The net profit attributable to the parent company is projected to be 821 million RMB, up 22% year-on-year [2] - The company's core product, PFA, has been well-promoted, leading to synergistic growth. The company emphasizes cost control, focusing R&D and sales expenses on market promotion, clinical validation, and next-generation product development [2] - The product pipeline is continuously advancing, with new products in coronary and peripheral business expected to enter a harvest phase. The company is actively conducting various marketing activities to enhance product coverage and admission rates [3] Financial Projections - The projected net profits for the company from 2025 to 2027 are 821 million RMB, 1.009 billion RMB, and 1.290 billion RMB, reflecting growth rates of 22%, 23%, and 28% respectively [4] - Revenue growth rates are expected to be 25.08% in 2025, 22.52% in 2026, and 26.85% in 2027 [9] - The diluted earnings per share are forecasted to be 5.818 RMB in 2025, 7.157 RMB in 2026, and 9.147 RMB in 2027 [9]

Core Insights - The coronary access devices are essential consumables for percutaneous coronary intervention (PCI) surgeries, directly impacting surgical outcomes and complication control [1][6] - The industry is supported by a series of policies in China, including centralized procurement, innovation approvals, and grassroots medical construction, laying a solid foundation for high-quality development [6][10] - The number of coronary artery disease patients is steadily increasing globally and in China, with projections indicating 220 million patients worldwide and 27.879 million in China by 2024, highlighting significant growth potential for the industry [10] Industry Overview - Coronary access devices are specialized medical equipment and consumables used in PCI surgeries to establish and maintain access from the body surface to the coronary arteries, ensuring the smooth execution of angiography, balloon dilation, and stent implantation [1][6] - The devices are categorized into four main types: puncture devices, catheter systems, sheath sets, and auxiliary devices for pressure monitoring and vascular closure [3][4] Development Background - The development of coronary access devices is crucial for reducing cardiovascular disease mortality, enhancing medical accessibility, and promoting high-end device localization [6][8] - Recent policies in China aim to improve centralized procurement mechanisms, accelerate innovation device approvals, and standardize medical insurance payments, providing guidance for industry development [6][10] Market Analysis - The global coronary balloon dilatation catheter market is expanding, with functional balloons growing at a faster rate; the market size is expected to increase from $560 million in 2020 to $960 million in 2024, with a compound annual growth rate (CAGR) of 8.49% [12][14] - In China, the market is characterized by structural adjustments and rapid growth, with the general balloon market experiencing a temporary decline due to centralized procurement but expected to rebound, while functional balloons are projected to grow significantly, with a CAGR of 19.28% from 2024 to 2028 [14][16] Competitive Landscape - The competitive landscape of the coronary access device industry is tiered, with foreign companies dominating the high-end market while domestic leaders are accelerating their market penetration; by 2024, domestic companies are expected to capture 54.9% of the coronary balloon market [14][15] Future Trends - The industry is expected to evolve along three main directions: technological upgrades, deepening domestic substitution, and expansion of grassroots markets [16] - Innovations such as biodegradable materials and smart functions will drive high-end product iterations, while local companies will enhance core component localization through material and manufacturing process advancements [17][18] - The promotion of tiered diagnosis and treatment will reshape market demand, with a growing need for cost-effective and standardized products suitable for grassroots settings [18]

在产品体系建设方面，公司已形成覆盖多治疗场景的完善产品矩阵，拥有50余个产品系列，产品应用领域涵 盖冠脉介入、外周介入、神经介入、血透通路及介入配件等关键领域，具体包含各类通用球囊导管、功能性 球囊导管、药物球囊导管、介入导丝与导管、多种血栓处理器械、钙化处理器械、能量治疗器械等核心产品 线，可充分满足临床对复杂血管疾病介入治疗的多样化需求。 据招股书，博迈医疗专注于高性能血管介入医疗器械的研发、生产及全球销售，是全球行业内技术及产品领 先的复杂血管疾病介入治疗解决方案提供商，同时也是国产血管介入球囊导管领域产销量领先的研发生产企 业。 在研发与生产布局方面，公司重视全球资源整合与产能保障，目前已在全球范围内设立5个研发中心及实验 室，持续推动核心技术迭代与创新产品研发;建立4个生产基地，确保产品规模化、高质量供应;同时搭建3个国 际运营中心，为全球市场拓展提供高效的运营支持与服务保障。 在市场覆盖维度方面，公司产品已成功行销海内外超100个国家和地区，服务于全球上万家医院及医疗中心， 凭借稳定的产品性能、成体系的治疗解决方案及专业的技术支持，在国内外血管介入医疗器械市场树立了良 好的品牌形象，逐步构建起全球 ...

Core Insights - The article discusses the registration and quality management system assessments for medical devices in Guangdong Province, highlighting various companies and their products that have undergone evaluations and received approvals or required modifications [2][5]. Group 1: Company Registrations - Guangdong Weinuodun Medical Technology Co., Ltd. received approval for its medical ozone therapy device on November 3, 2025 [3]. - Guangdong Baisheng Medical Instrument Co., Ltd. passed the evaluation for high-frequency surgical equipment on November 3, 2025 [3]. - Shenzhen Kefu Biotechnology Co., Ltd. was approved for its continuous glucose monitoring system on November 4, 2025 [3]. - Guangzhou Wanfu Biological Technology Co., Ltd. received approval for its hepatitis B virus nucleic acid testing kit on November 10, 2025 [3]. - Shenzhen Karman Medical Equipment Co., Ltd. was approved for its intracranial pressure sensor and cerebrospinal fluid drainage set on November 12, 2025 [3]. Group 2: Quality Management System Assessments - The Guangdong Provincial Drug Administration is implementing a quality management system assessment for Class II medical devices, with results communicated to applicants via SMS or web queries since May 2022 [5]. - Companies such as Shenzhen Aibo Hechuang Medical Robot Co., Ltd. received approval for their vascular intervention surgery control system on November 27, 2025 [5]. - Guangdong Tiancheng Tianmei Medical Technology Co., Ltd. was approved for absorbable surgical sutures on November 19, 2025 [4].

人民财讯8月4日电，国家药监局发布公告称，按照《医疗器械监督管理条例》规定，根据企业申请，国 家药品监督管理局现注销11家企业共20个产品的医疗器械注册证。其中包括：深圳麦科田生命科学有限 公司的2个产品：冠状动脉球囊扩张导管，注册证编号：国械注准20223030549；非顺应性冠状动脉球囊 扩张导管，注册证编号：国械注准20223030559。 ...