上市企业：开立医疗（300633） 相关企业：波科国际医疗贸易（上海）有限公司、飞利浦医疗器械（上海）有限公司、深圳北芯生命科 技股份有限公司、天津恒宇医疗科技有限公司、全景恒升（北京）科学技术有限公司、上海博动医疗科 技股份有限公司、深圳市赛禾医疗技术有限公司、深圳微创踪影医疗装备有限公司、苏州博动戎影医疗 科技有限公司、西安华峰医疗科技有限公司 关键词：血管内超声（IVUS）系统市场政策、血管内超声（IVUS）系统产业链图谱、血管内超声 （IVUS）系统采购规模、血管内超声（IVUS）系统竞争格局、血管内超声（IVUS）系统发展趋势 一、概述 内容概要：我国心血管疾病发病率随人口老龄化不断攀升，在冠脉介入手术中，血管内超声（IVUS） 系统能精准评估斑块、指导支架植入，降低术后不良事件发生率，其临床价值已获广泛认可，除传统冠 脉领域外， IVUS在主动脉瓣置换术术前评估、外周动脉疾病诊疗等场景的应用也在逐步拓展，此外， 随着临床医生对精准医疗的重视程度不断提升，IVUS能清晰呈现血管壁结构和病变细节，有效降低介 入手术的并发症风险，其临床价值已得到广泛认可，目前三级医院已形成IVUS常规使用规范，基层医 ...

Core Viewpoint - Tianjin Hengyu Medical Technology Co., Ltd. has completed nearly 100 million RMB financing, which will be used to advance the research, production, and commercialization of vascular interventional imaging and treatment products, aiming to build a rare integrated platform for vascular interventional diagnosis and treatment in China [1][15]. Market Situation - The global vascular imaging market is experiencing steady growth due to the rising incidence of cardiovascular diseases and the increasing demand for minimally invasive procedures, leading to a significant rise in the need for high-resolution, low-trauma imaging and navigation systems [2]. - In China, the intravascular imaging market has been dominated by foreign brands, but the rise of domestic companies, policy support, and clinical promotion are gradually increasing the localization rate of intravascular imaging devices [2]. - The domestic vascular imaging and interventional systems market is expected to see rapid growth in the coming years, with trends such as AI-enabled imaging analysis and personalized precision intervention reshaping the industry landscape [2]. Company Overview - Hengyu Medical, established in 2016 and headquartered in Tianjin, focuses on intravascular ultrasound (IVUS), optical coherence tomography (OCT), and their derivative multimodal imaging and interventional solutions [5]. - The company possesses a unique capability to master both IVUS and OCT technologies, further developing integrated multimodal imaging systems, which provides a high technical barrier and platform construction advantage [6]. Product Development - Hengyu Medical has been advancing product registration, clinical collaboration, and industrialization verification, forming a series of proprietary intellectual property and production capabilities [8]. - The company has established a complete product matrix covering imaging diagnosis and interventional treatment, including IVUS, OCT, OCT-NIRS, 4D ICE, and laser ablation systems, creating a full-chain layout from imaging acquisition to treatment execution [9]. Technology and Innovation - The IVUS system developed by the company supports real-time intravascular ultrasound imaging, providing accurate assessments of vascular wall structure and plaque burden [11]. - The OCT system utilizes high-speed optical interference technology, achieving micron-level imaging precision, suitable for complex coronary intervention pre-assessment and post-verification [12]. - The OCT-NIRS dual-modal system innovatively combines OCT structural imaging with near-infrared spectroscopy (NIRS) for simultaneous structural and chemical composition analysis, aiding in plaque stability assessment and intraoperative risk evaluation [13]. - The 4D ICE and laser ablation systems enhance procedural navigation and effectively ablate calcified plaques, improving surgical success rates and safety [14]. Conclusion - The recent financing reflects the capital market's ongoing confidence in the domestic vascular interventional imaging and treatment sector, with Hengyu Medical's dual-modal imaging and cross-vascular system layout driving strategic upgrades from cardiovascular to broader vascular applications [15][16]. - In the context of accelerating trends in precision medicine and AI empowerment, Hengyu Medical is poised to become a representative enterprise in the domestic high-end medical imaging equipment field, contributing to the enhancement of China's independent innovation capabilities in vascular interventional diagnosis and treatment [16][17].

Core Mission - The company aims to transform scientific research into practical technology to benefit patients, focusing on innovative high-performance medical devices [1] - The mission is to improve life and health through innovation and quality, specifically targeting cardiovascular disease intervention [1] Product Development - The company has developed a comprehensive solution for precise intervention in coronary heart disease, including the FFR system and IVUS system [1] - The FFR pressure microcatheter, launched in 2020, is the first domestically approved product in China for measuring blood flow reserve, filling a significant gap in the market [4] - The IVUS system is the first domestically developed 60MHz high-definition product approved by the National Medical Products Administration, rapidly gaining market share since its launch in 2022 [5] Market Impact - The FFR product achieved a market share of 30.6% in the coronary artery direct measurement market within a year of its launch, with applications in approximately 1,000 hospitals globally [4] - The IVUS system has also been adopted in around 1,000 hospitals, becoming the leading domestic product in its category [5] Innovation and Technology - The company has established four core technology platforms, including micro-nano device development and high-performance medical hardware development [6] - It has developed nearly 20 products and ongoing projects, positioning itself as a "small giant" in the cardiovascular intervention sector with international influence [6] Recognition and Achievements - The company has applied for over 360 patents, with more than 180 granted, including over 80 invention patents [6] - It has received various accolades, including the "National Specialized and Innovative 'Small Giant' Enterprise" certification and the Shenzhen Science and Technology Progress Award for its FFR system [6]

Group 1 - The medical sector is experiencing significant growth, with companies like Kangfang Biotech, BeiGene, and China National Pharmaceutical Group showing strong performance, alongside high-value consumables companies such as Xinmai Medical and Nanwei Medical [1] - North Chip Life Technology Co., Ltd. is preparing for an IPO on the Sci-Tech Innovation Board, with the listing review meeting scheduled for July 18, 2025 [2][3] - North Chip Life focuses on precision diagnostic devices for cardiovascular diseases, with a valuation of 4.8 billion yuan, backed by investors like Song Liang and Songhe Capital [4][6] Group 2 - North Chip Life was established in December 2015 and is headquartered in Shenzhen, with major institutional investors including Xiaerba and Songhe Capital [5][6] - The company has developed 11 products and has 6 in the pipeline, covering categories such as IVUS systems and FFR systems [15] - The IVUS system, a core product, was approved for sale in China in July 2022 and has been implemented in approximately 1,000 hospitals [17] Group 3 - The market for IVUS devices in China is projected to grow from approximately 1.76 billion yuan in 2024 to about 5.11 billion yuan by 2030, with a compound annual growth rate of around 19.4% [19] - The FFR measurement system, another key product, is expected to see its market size increase from about 230 million yuan in 2024 to approximately 3.12 billion yuan by 2030, with a compound annual growth rate of about 54.9% [24] - North Chip Life's revenue from the FFR system accounted for 87.31% in 2022, dropping to 24.48% in 2024, while revenue from the IVUS system rose from 10.14% to 68.62% during the same period [28][29] Group 4 - The company reported revenues of 92.45 million yuan, 184 million yuan, and 317 million yuan for the years 2022, 2023, and 2024, respectively, with net losses of 290 million yuan, 140 million yuan, and 43.6 million yuan [26] - As of the end of 2024, North Chip Life had cash and cash equivalents of approximately 15.04 million yuan, indicating financial pressure [26] - The company faces high sales and research expenses, with sales expenses accounting for 82.08%, 55.98%, and 34.61% of revenue during the reporting period [31]

Core Insights - The National Medical Products Administration of China emphasizes support for high-end medical device innovation, particularly in advanced medical imaging equipment, to address the growing global demand for cardiovascular disease treatment solutions [1] - Beixin Life, a domestic company focused on high-end medical device innovation, aims to develop high-performance interventional medical devices to tackle the significant public health issue of cardiovascular diseases [1][3] - The company has successfully developed and commercialized proprietary high-performance diagnostic equipment, contributing to the advancement of domestic high-end medical devices [1][3] Industry Overview - Coronary heart disease is recognized as a major health threat globally, with cardiovascular diseases being the leading cause of death in China [2] - China has the highest annual volume of percutaneous coronary intervention (PCI) procedures, with a trend towards precision treatment guided by advanced coronary functional and imaging technologies [2] - The reliance on imported devices and materials has historically dominated the market due to high R&D barriers and long return cycles [2] Company Achievements - Since its establishment in 2015, Beixin Life has developed a series of intelligent cardiovascular interventional solutions, including the first domestically approved IVUS and FFR systems [3][4] - The company has obtained over 20 Class III medical device registrations and successfully launched 11 products [3] - Beixin Life is the only domestic company with the technology to develop and manufacture 60MHz high-frequency micro-ultrasound transducers and MEMS pressure sensor modules [4] Market Potential - The cardiovascular device market is the second largest globally and is expected to grow rapidly over the next decade, with a significant patient population for coronary heart disease [7] - The number of PCI procedures in China is projected to increase from 1.906 million in 2024 to 4.298 million by 2030, with a compound annual growth rate of approximately 14.5% [7] - The precision PCI market in China is expected to grow from 2.04 billion yuan in 2022 to 9.42 billion yuan by 2030, with a compound annual growth rate exceeding 20% [7] Competitive Position - Beixin Life's FFR product captured 30.6% of the domestic market share shortly after its launch, while its IVUS product became the leading domestic option, reducing reliance on imports [8] - The company has successfully expanded its products to international markets, receiving positive feedback and achieving routine clinical use in multiple countries [8] - Beixin Life aims to enhance the synergy of its product system and adapt to international markets, thereby improving the global competitiveness of China's high-performance medical device industry [9]