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手握最全产品矩阵 商业化进程全面领跑 人工心脏龙头企业核心医疗上会在即

张小夏 2026-06-30 06:27
张小夏 2026/06/30 06:27

邦小白快读

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本文核心信息是国产人工心脏龙头企业深圳核心医疗,将于7月2日在上交所科创板IPO上会,冲刺“人工心脏第一股”,核心干货如下

1. 产品技术方面:核心医疗拥有两款商业化产品,Corheart 6是全球体积最小、重量最轻的商业化全磁悬浮植入式人工心脏,累计植入超1300例,2年生存率达86%,性能优于国际同类产品,CorVad 4.0是国内首款获批的介入式人工心脏,技术达到国际领先水平;

2. 企业布局方面:核心医疗是全球唯一同时实现植入式、介入式人工心脏双线商业化的企业,拥有业内最全面的产品管线,覆盖全年龄段、全场景临床需求,2025年1-5月Corheart 6国内市占率超52%,位居行业第一;

3. 行业前景方面:全球人工心脏需求缺口大,市场将快速扩容,本次上市后核心医疗将进一步推进技术创新和全球化布局。

本文为创新医疗器械品牌的发展提供了多维度的参考干货,具体如下

1. 产品研发方向:可以走差异化原创技术路线,依托本土市场优势实现率先突破,不必局限于跟随海外竞品的路线,核心医疗打破了全球人工心脏市场的海外寡头垄断,实现国产引领而非简单国产替代,还依托本土优势打造出海竞争力;

2. 品牌竞争策略:要打造多产品矩阵形成生态壁垒,核心医疗凭借植介入双线布局,覆盖全场景临床需求,形成“主力领航+管线接力”的梯队格局,依托标杆产品的口碑带动全矩阵推广,有效提升品牌影响力;

3. 政策与全球化布局:充分利用国内创新医疗器械审评审批绿色通道,缩短上市周期优先抢占市场,依托本土庞大病例资源积累真实世界数据,完成本土化验证后再推进全球化扩张,降低出海风险。

本文披露了人工心脏赛道的增长机会、政策红利以及发展方向,干货如下

1. 增长市场机会:全球心衰患者近6300万人,心脏移植供体短缺,人工心脏临床需求缺口极大,预计2033年全球植入式人工心脏市场规模将达40.8亿美元,2024-2033年复合增长率14.3%,介入式中短期人工心脏市场规模将达93.3亿美元,复合增长率18.2%,介入式覆盖更广,增速更快,增量空间更大;

2. 相关政策红利:国内对国内首创、国际领先的创新医疗器械开通审评审批绿色通道,能够有效缩短产品上市周期,帮助企业优先抢占市场,核心医疗纳入绿色通道的产品数量位居国内人工心脏领域第一;

3. 发展路径参考:先扎根本土市场完成产品商业化验证,积累真实世界数据,建立市场口碑,再依托本土验证的优势推进全球化拓展,核心医疗国内市占率第一,已经完成全球化铺垫,具备出海基础。

本文对医疗器械生产工厂把握需求、抓住产业机会有较多启示,干货如下

1. 产品生产设计需求:人工心脏赛道存在大量未被满足的临床需求,产品设计方向明确,需要围绕小型化、低功耗、高血液相容性、低不良事件率做技术突破,无论是长期植入式产品,还是针对高危PCI、心原性休克的短期介入式产品,都有明确的市场需求;

2. 商业机会:人工心脏赛道技术和工艺壁垒高,全球范围内具备研发商业化能力的企业极少,目前我国已经实现国产引领,本土企业不仅占据国内市场,还开始拓展全球市场,赛道整体增长空间大,给上游配套生产工厂带来充足的业务增量;

3. 发展启示:企业可以依托本土庞大的病例资源快速完成产品验证和技术积累,逐步打磨产品性能,再推进全球化布局,同时要注重技术沉淀和产品梯队布局,持续迭代创新,保持长期竞争力。

本文梳理了人工心脏赛道的行业趋势、客户痛点,为医疗器械相关服务商提供了方向,干货如下

1. 行业发展趋势:全球人工心脏市场即将进入快速扩容期,植入式和介入式产品都保持两位数的年复合增长,其中介入式产品覆盖更广泛的患者群体和临床场景,市场规模更大、增速更快,是未来重要的增长引擎,目前赛道供给缺口大,发展空间充足;

2. 核心客户痛点:临床端在高危PCI、心原性休克等场景,传统治疗方案存在明显局限性,救治缺口大,对提升手术安全性、患者生存率的产品需求强烈未被满足,人工心脏企业需要突破磁悬浮控制、微型电机等核心技术的瓶颈,解决小型化、溶血等问题;

3. 服务方向:可以围绕原创核心技术环节布局,针对磁悬浮控制技术、微型化电机技术等领域提供技术服务,帮助企业实现技术突破,同时可依托本土资源,帮助企业积累真实世界临床证据,加快产品审评上市进度。

本文为医疗相关平台把握赛道机会、做好运营布局提供了参考,干货如下

1. 赛道需求方向:创新医疗器械尤其是人工心脏赛道,已经实现国产引领,市场需求缺口大,增长速度快,头部企业已经完成商业化验证,具备明确的融资扩张需求,核心医疗即将通过科创板上市融资,进一步推进技术创新和全球化布局;

2. 平台招商布局机会:可以重点引入拥有原创核心技术、多产品矩阵布局、完成本土商业化验证的创新医疗器械企业,这类企业成长性强,像核心医疗作为全球唯一实现植介入双线商业化的人工心脏龙头,产品管线完善,国内市占率第一,竞争力突出;

3. 风险规避方向:人工心脏赛道技术壁垒高、研发周期长,平台需要优先选择已经进入创新医疗器械绿色通道、完成临床验证的项目,这类项目上市周期更短,商业化进度更快,能够有效降低平台的项目风险,同时也能更快兑现价值。

本文披露了人工心脏产业的最新发展动向,为产业研究提供了丰富的干货素材,具体如下

1. 产业发展新动向:我国人工心脏产业走出了差异化发展路径,已经实现国产引领而非简单的进口替代,本土企业依靠原创性技术突破实现产品性能反超海外竞品,核心医疗作为行业龙头,已经成为全球唯一实现植入式、介入式人工心脏双线商业化的企业,开始从本土领先向全球拓展推进;

2. 市场结构新变化:全球人工心脏市场中,介入式中短期产品的市场规模和增长速度都已经超过植入式产品,成为赛道新的增长引擎,本土庞大的病例资源成为中国企业的独特优势,能够帮助企业快速积累真实世界证据,支撑全球化拓展;

3. 竞争与政策新总结:国内创新医疗器械审评绿色通道政策,有效加速了优质创新产品的上市进程,人工心脏赛道的竞争逻辑已经从单一产品突围转向多产品矩阵生态竞争,完善的产品矩阵本身就是重要的竞争壁垒,能够提升企业经营韧性。

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Quick Summary

This article covers CoreHeart Medical, China's leading artificial heart company, which will undergo its Shanghai STAR Market IPO hearing on July 2 to become the world's first publicly listed pure-play artificial heart manufacturer. Key takeaways are as follows:

1. Product and technology: CoreHeart has two commercialized products. Its Corheart 6 is the world's smallest and lightest commercial fully magnetic levitation implantable artificial heart, with over 1,300 cumulative implantations and a 2-year patient survival rate of 86% — outperforming comparable international products. Its CorVad 4.0 is China's first approved interventional artificial heart, with technology reaching global leading standards.

2. Corporate positioning: CoreHeart is the only company in the world to have achieved commercialization for both implantable and interventional artificial hearts. It boasts the industry's most comprehensive product pipeline covering all age groups and full clinical scenarios. From January to May 2025, Corheart 6 held over 52% domestic market share, ranking first in the industry.

3. Industry outlook: The global artificial heart market faces massive unmet demand and is poised for rapid expansion. Following this IPO, CoreHeart will further advance technological innovation and global expansion.

This article provides multi-dimensional insights for innovative medical device brands, as outlined below:

1. R&D direction: Brands can pursue differentiated original technology routes and achieve breakthroughs first by leveraging local market advantages, rather than limiting themselves to following overseas competitors. CoreHeart has broken the global artificial heart market's oligopoly held by foreign players, achieving Chinese leadership rather than simple import substitution, and has built global competitiveness on the back of local advantages.

2. Brand competition strategy: Brands should build a multi-product matrix to establish ecological barriers. CoreHeart's dual layout of implantable and interventional products, covering full clinical scenarios, forms a tiered structure of "flagship leadership + pipeline follow-up", leveraging the reputation of its benchmark product to drive promotion across the entire product matrix, effectively boosting brand influence.

3. Policy and global expansion: Brands should make full use of China's fast-track review and approval pathway for innovative domestic medical devices to shorten time-to-market and capture market share early. Leveraging China's large patient base to accumulate real-world data for domestic validation before expanding globally also helps reduce overseas expansion risks.

This article outlines the growth opportunities, policy dividends and development directions of the artificial heart track. Key insights are as follows:

1. Growth opportunities: There are nearly 63 million heart failure patients worldwide, and a severe shortage of heart transplant donors, creating an enormous gap in clinical demand for artificial hearts. The global implantable artificial heart market is projected to reach $4.08 billion by 2033, with a 14.3% CAGR from 2024 to 2033. In comparison, the global short-to-medium term interventional artificial heart market will reach $9.33 billion over the same period, with an 18.2% CAGR — meaning the interventional segment covers a broader patient base, grows faster and offers larger incremental growth space.

2. Policy dividends: China offers a fast-track review and approval pathway for first-in-China, globally leading innovative medical devices, which effectively shortens product launch timelines and helps companies capture market share early. CoreHeart has more products approved for the fast-track pathway than any other domestic artificial heart player.

3. Development roadmap reference: Companies should first root themselves in the domestic market to complete commercial validation of their products, accumulate real-world data and build market reputation, then leverage the advantage of domestic validation to advance global expansion. CoreHeart already holds the leading domestic market share, has completed prerequisites for globalization and is well positioned to expand overseas.

This article offers valuable insights for medical device manufacturing factories to capture market demand and industry opportunities, as follows:

1. Product design and manufacturing requirements: The artificial heart track has significant unmet clinical demand, with a clear product design direction. Technological breakthroughs are needed around miniaturization, low power consumption, high hemocompatibility, and low adverse event rates, with clear market demand for both long-term implantable products and short-term interventional products for high-risk PCI and cardiogenic shock.

2. Business opportunities: The artificial heart track has high technical and process barriers, with very few companies globally capable of R&D and commercialization. China has now achieved domestic technological leadership in the sector; local companies not only dominate the domestic market but are also starting to expand globally. The large overall growth space of the track brings sufficient incremental business to upstream supporting manufacturing factories.

3. Development insights: Companies can leverage China's large patient base to rapidly complete product validation and technological accumulation, refine product performance gradually before advancing global expansion. At the same time, companies should prioritize technological accumulation, tiered product pipeline布局, and continuous iterative innovation to maintain long-term competitiveness.

This article outlines industry trends and core pain points in the artificial heart track, and provides direction for relevant medical device service providers, as follows:

1. Industry trends: The global artificial heart market is about to enter a period of rapid expansion, with both implantable and interventional products posting double-digit annual compound growth. Interventional products cover a broader range of patients and clinical scenarios, feature a larger market size and faster growth, and will serve as a key growth engine going forward. The track currently has a large supply gap and ample development space.

2. Core customer pain points: For clinical scenarios such as high-risk PCI and cardiogenic shock, traditional treatment protocols have clear limitations, with a large unmet need for products that improve surgical safety and patient survival. Artificial heart companies need to break through bottlenecks in core technologies including magnetic levitation control and micro motors, to solve challenges such as miniaturization and hemolysis.

3. Service direction: Service providers can build布局 around core original technology links, offering technical services for magnetic levitation control and micro motor technology to help companies achieve technological breakthroughs. At the same time, providers can leverage local resources to help companies accumulate real-world clinical evidence and accelerate product review and approval.

This article provides reference for healthcare-related platforms to capture track opportunities and optimize operational布局, as follows:

1. Track demand: The innovative medical device sector, particularly artificial hearts, has already achieved Chinese technological leadership, with large unmet market demand and rapid growth. Leading players have already completed commercial validation and have clear demand for financing and expansion. CoreHealth is set to raise capital via a STAR Market IPO to further advance technological innovation and global expansion.

2. Investment and recruitment opportunities: Platforms should prioritize onboarding innovative medical device companies that own core original technology, have a multi-product matrix布局, and have completed domestic commercial validation. These companies have strong growth potential. CoreHealth, as the world's only artificial heart leader with dual commercialization of implantable and interventional products, has a complete product pipeline, holds the top domestic market share, and boasts outstanding competitiveness.

3. Risk mitigation: The artificial heart track has high technical barriers and long R&D cycles, so platforms should prioritize projects that have been accepted into China's innovative medical device fast-track pathway and completed clinical validation. These projects have shorter time-to-market and faster commercial progress, which effectively reduces platform project risk while delivering value faster.

This article discloses the latest development trends of the artificial heart industry, and provides rich data and insights for industry research, as follows:

1. New industry trends: China's artificial heart industry has carved out a differentiated development path, achieving domestic technological leadership rather than simple import substitution. Local Chinese players have outperformed overseas competitors in product performance through original technological breakthroughs. As the industry leader, CoreHeart is the only company in the world to achieve dual commercialization of implantable and interventional artificial hearts, and is advancing from domestic leadership to global expansion.

2. New changes in market structure: In the global artificial heart market, short-to-medium term interventional products have already outpaced implantable products in both market size and growth rate, becoming the track's new growth engine. China's large domestic patient pool is a unique advantage for Chinese companies, enabling them to accumulate real-world evidence rapidly to support global expansion.

3. Updated summary of competition and policy: China's fast-track review policy for innovative medical devices has effectively accelerated the launch of high-quality innovative products. The competitive logic of the artificial heart track has shifted from single-product breakthrough to multi-product matrix ecological competition; a complete product matrix itself is an important competitive barrier that enhances business resilience.

Disclaimer: The "Quick Summary" content is entirely generated by AI. Please exercise discretion when interpreting the information. For issues or corrections, please email run@ebrun.com .

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这家人工心脏创新龙头企业,正凭借突破性的原创技术、业内最为全面的产品矩阵以及领先的商业化进程,引领行业价值升级,向着“人工心脏第一股”发起冲刺。

上交所上市委会议公告显示,深圳核心医疗科技股份有限公司(以下简称“核心医疗”)科创板IPO定于7月2日上会。这家人工心脏创新龙头企业,正凭借突破性的原创技术、业内最为全面的产品矩阵以及领先的商业化进程,引领行业价值升级,向着“人工心脏第一股”发起冲刺。

产品力突围:原创技术构筑全球领先实力

长期以来,全球人工心脏市场呈现高度集中的寡头垄断格局。但与多数高端医疗器械赛道不同,我国人工心脏市场走出了一条差异化发展路径:国产产品率先实现国内获批上市并投入临应用,海外竞品进入中国市场时间相对滞后。行业发展已实现国产引领的格局,并非简单的国产替代。凭借技术上的突破性创新与敢于挑战“无人区”的勇气,国产人工心脏正在打造出差异化产品,借助本土市场优势,进一步扬帆出海,在全球市场与海外巨头同台竞技。

在植入式人工心脏领域,核心医疗核心技术产品Corheart 6填补了国际上超小型全磁悬浮人工心脏医疗器械空白。截至目前,Corheart 6的累计植入量已突破1300例,成为全球第二款、中国首款突破千例大关的全磁悬浮人工心脏,推动行业从“技术探索期”迈向“规模化应用期”。

这一数据背后是Corheart 6在技术路线和产品性能上的全面突破。该产品采用国际原创的“分时分区动态轴向全磁悬浮控制技术”等核心技术,突破了传统径向磁悬浮方案在体积、功耗等方面的迭代瓶颈,成为目前全球体积最小、重量最轻的商业化全磁悬浮植入式人工心脏,并提升了血液相容性等。国产首个人工心脏基于注册临床队列的长期随访临床研究的结果显示,Corheart 6植入后2年生存率达86%,相较于国际同类主流产品HeartMate 3的2年生存率76.9%,展现出优秀的生存获益表现。同时,Corheart 6在提升患者生存率、改善生活质量方面效果显著,且低不良事件发生率处于国际领先水平,2年随访期间未发生泵血栓形成、设备故障或溶血等不良事件,标志着国产人工心脏在长期可靠性上已跻身国际领先水平。

在介入式人工心脏领域,核心医疗自主研发了国内首款获批上市的介入式人工心脏产品CorVad 4.0,这款产品也在技术对标国际领先水平的基础上,进一步实现了差异化创新,致力于更好地满足临床需求。

面对高危PCI和心原性休克两大临床应用场景下庞大的患者群体,国内市场上的传统治疗方式各有局限性,造成巨大的救治缺口,临床层面对于提升手术安全性和患者生存率存在较为强烈且未被满足的需求。介入式人工心脏具备创伤小、操作简单、可及性强的特点,且能够实现更主动、稳定的流量血流辅助。

CorVad 4.0的差异化优势,体现在其采用了国际原创的血管内微型化“轴向磁通多驱电机技术”,将电机直径缩小至4—5毫米,有效提升整体电机效率,降低功耗和泵体温升,并提升了血液相容性与使用寿命。在体外溶血试验中,CorVad 4.0的修正溶血指数(MIH)较国际竞品下降近95%。事实上,核心医疗作为全球唯一实现“植介入”双线商业化的人工心脏龙头,将其在植入式领域所沉淀的轴向电机系统技术优势延展到了介入式产品上,为全球市场带来了全新的技术解决方案。

多产品矩阵协同:从市占第一到生态布局

创新医疗器械的竞争逻辑,不仅在于单一产品突围,更在于多产品矩阵的生态制胜,以实现强化临床协同,增强企业的经营韧性。

在人工心脏领域,生态制胜的逻辑更是硬核,这一赛道本身技术和工艺壁垒较高,全球范围内具备研发及商业化能力的企业寥寥无几,拥有完善的产品矩阵本身即一种竞争壁垒。目前,全球范围内仅核心医疗一家企业同时实现植入式与介入式人工心脏的双线商业化。这也将成为国产企业在这一领域赶超国际巨头的突破点之一。

同时,核心医疗产品创新迭代效率居于行业前列,拥有行业内最为丰富的产品管线布局,全面覆盖“长期→短期、左心→双心、幼儿→成人”的临床需求。其中,已有2款实现商业化,4款产品系列(包含左心植入、双心植入、左心介入及右心介入产品)进入我国创新医疗器械特别审查程序,4款产品处于临床及后续阶段,形成“主力产品领航+管线产品接力”的梯队格局。

多产品策略既满足了临床需求多样化,提升治疗可及性,也能借助部分标杆产品的市场认可度带动全矩阵推广,以全面的解决方案提升品牌影响力与价值。

核心医疗产品矩阵的快速商业化落地,也离不开国内创新医疗器械审评审批“绿色通道”的政策赋能。该通道旨在加速国内首创、国际领先技术产品的上市。目前,核心医疗纳入绿色通道的产品数量位居我国人工心脏领域首位,有望缩短国内上市周期,优先抢占市场。

国内市场验证商业化能力助推全球化发展

庞大的本土市场是中国医疗器械企业的独特优势,为创新产品商业化落地与优化升级提供了天然的试验场。业内专家也指出,中国庞大病例数据将快速积累真实世界证据,中国数据有望引导全球人工心脏产品的使用策略。

核心医疗的全球化布局,亦将依托这一优势加速落地、兑现价值。在国内市场上,其首款商业化产品Corheart 6的市占率持续位居行业首位且呈现上升趋势,2025年1—5月的当期植入量占比已超过52%。这不仅验证了其产品优势,更为其在海外市场的推广奠定坚实的根基。正如麦肯锡《中国医疗器械展望2025》所指出,本土化验证是全球化的基础。核心医疗已顺利完成从“本土领先”到“全球拓展”的关键铺垫,有望加速全球化发展。

放眼海外,全球人工心脏市场是一片更辽阔的市场。根据弗若斯特沙利文数据,2024年全球心衰患者总数近6300万人,然而,心脏移植始终受限于供体短缺,2023年全球仅完成约1万例,临床需求缺口较大。在此背景下,市场有望快速扩容,根据弗若斯特沙利文预计,2033年全球植入式人工心脏市场规模将达到40.8亿美元,2024年至2033年的复合年增长率高达14.3%。

同时,介入式产品的市场潜力更为突出,其覆盖更为广泛的患者群体和临床场景,相比植入式产品的市场规模更大、增速更快,将为赛道上的玩家提供更多成长动能。根据弗若斯特沙利文的统计,预计2033年全球中短期人工心脏市场规模将达到93.3亿美元,2024年至2033年的复合年增长率为18.2%。

通过本次科创板上市,核心医疗亦将进一步推动人工心脏产品技术创新发展及全球化进程。这将为其自身及中国创新医疗器械行业的发展注入新的活力,也有望惠及全球更多心衰患者。

注:文/张小夏,文章来源:钛媒体(公众号ID:taimeiti),本文为作者独立观点,不代表亿邦动力立场。

文章来源:钛媒体

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