ArteryFlow Technologies Files IPO Prospectus: Pioneering an End-to-End Precision Clinical Ecosystem for Cardio-Cerebrovascular Disease Management Across In-Hospital and Out-of-Hospital Settings

Cardiovascular and cerebrovascular diseases are known as the “leading killer” threatening human health, and clinical practice has long been striving to overcome diagnostic and therapeutic challenges.

According to the "Report on Cardiovascular Health and Diseases in China 2020," there are approximately 330 million patients with cardiovascular diseases in China, including 13 million stroke patients and 11.39 million patients with coronary heart disease. Cardiovascular and cerebrovascular diseases have high rates of disability and mortality, which not only place a significant burden on patients' families but also increase the national medical insurance burden, with total costs reaching trillions of yuan.

In recent years, interventional therapy for cardiovascular and cerebrovascular diseases has developed rapidly, with the number of percutaneous coronary intervention (PCI) procedures in China exceeding 1 million in 2021. However, the treatment rate for these conditions remains low in China, indicating that a clinical strategy focused solely on treatment is unsustainable.

The progression of cardiovascular and cerebrovascular diseases is a long-term, gradual process. In addition to precise in-hospital treatment, links such as screening, diagnosis, post-discharge management, and out-of-hospital monitoring all influence the overall treatment rate of these conditions. Therefore, establishing an ecological closed loop that covers the entire continuum of care for cardiovascular and cerebrovascular diseases, both inside and outside the hospital, represents the new pathway to breaking through current challenges.

As the aging of China's population intensifies, the number of individuals suffering from cardiovascular and cerebrovascular diseases continues to rise.

In China, the early screening rate for cardiovascular and cerebrovascular diseases is not high, and early intervention is inadequate. Due to the insidious onset and lack of obvious related symptoms, these diseases are prone to misdiagnosis and missed diagnosis in clinical practice. Moreover, the treatment of cardiovascular and cerebrovascular diseases is challenging, resulting in a low clinical treatment rate that is largely concentrated in tertiary hospitals, with even lower treatment rates in primary care settings. Meanwhile, post-discharge management remains insufficient; many patients fail to regularly monitor their condition or adhere to therapeutic measures after discharge, which easily leads to disease recurrence.

Clinical Practice Strongly Advocates for Early Diagnosis and Treatment of Cardiovascular and Cerebrovascular Diseases. The onset and progression of cardiovascular and cerebrovascular diseases is a gradual process; early screening of at-risk patients and timely management can slow disease development and prevent complications such as heart failure.

Meanwhile,Cardiovascular and Cerebrovascular Diseases: Emphasis on Concurrent Diagnosis and Integrated Treatment, to jointly intervene in cardiovascular and cerebrovascular diseases, control vascular risk factors, and improve blood supply to the heart and brain by enhancing circulatory system function. The body’s entire vascular network is interconnected; Academician Ge Junbo has proposed the concept of “pan-vascular disease.” Atherosclerosis constitutes the common pathological basis for both cardiovascular and cerebrovascular diseases and serves as the medical theoretical foundation advocating the concurrent treatment of heart and brain conditions in clinical practice.

With the advancement of medical imaging and minimally invasive technologies, the treatment rate for cardiovascular and cerebrovascular diseases is rising.However, existing solutions on the market are largely concentrated on in-hospital imaging interpretation and treatment for cardiovascular and cerebrovascular diseases, while links such as early screening, risk assessment, precise diagnosis, and post-discharge management remain relatively weak. The prevention and control of cardiovascular and cerebrovascular diseases should be patient-centered, implementing comprehensive, full-cycle management.

Addressing existing challenges, ArteryFlow Technology leverages its artificial intelligence and hemodynamic technologies to propose a one-stop solution covering the entire process of screening, diagnosis, and treatment for cardiovascular and cerebrovascular diseases. It aims to create a precise clinical ecosystem loop applicable in both in-hospital and out-of-hospital settings, dedicated to improving early detection rates, enhancing treatment efficacy, and reducing mortality and healthcare costs.

China’s intelligent diagnosis and treatment sector for cardiovascular and cerebrovascular diseases remains a blue ocean. The management of these conditions is challenging, and the development of related intelligent screening and diagnostic products is by no means an easy task.The integration of multidisciplinary fields, including clinical medicine, hemodynamics, and solid mechanics, is the core of product development., only by starting from clinical practice can we clearly identify clinical pain points and improve products in close alignment with clinical needs, while hemodynamics plays a decisive role in the diagnosis and treatment of cardiovascular and cerebrovascular diseases.

Since its inception, ArteryFlow Technology has collaborated with world-leading interventional centers and renowned medical institutions, including the Gates Vascular Institute (GVI) in Buffalo, USA, as well as The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhongshan Hospital, Changhai Hospital, Huashan Hospital, and Beijing Tiantan Hospital. Leveraging a robust model of close collaboration between medicine and engineering, ArteryFlow Technology has identified critical clinical pain points in the diagnosis and treatment of cerebrovascular and cardiovascular diseases—namely, the lack of an integrated, one-stop solution for precise screening, diagnosis, and therapy.

The company also boasts four major technology platforms: computational fluid dynamics, artificial intelligence, medical image processing, and finite element analysis, with profound technical expertise in fields such as hemodynamics and artificial intelligence.

Leveraging the commonalities between cerebrovascular and cardiovascular diseases, ArteryFlow Technology has established two major product pipelines. In the cerebrovascular domain, it focuses on three specific segments: intracranial aneurysms, acute cerebral infarction, and intracranial stenosis. In the cardiovascular domain, it concentrates on areas such as coronary heart disease and structural heart disease.

Taking intracranial aneurysms as an example, ArteryFlow Technology’s one-stop solution demonstrates significant value. The prevalence of intracranial aneurysms is approximately 7%, meaning that 7 out of every 100 adults are affected. Patients with intracranial aneurysms typically exhibit no obvious symptoms in the early stages; however, once an aneurysm ruptures and causes hemorrhage, the mortality rate rises sharply, necessitating prompt treatment.

Xiang Jianping, founder of ArteryFlow Technology, stated: “First, we aim to identify aneurysms at an early stage for timely treatment. Second, we need to accurately assess the risk of aneurysm rupture using medical imaging and hemodynamics. Next comes the formulation of specific surgical plans, including surgical clipping, endovascular embolization, and flow diversion therapy. For intraoperative procedures involving flow-diverting stents, we provide precise recommendations for device selection and placement, allowing physicians to make final, concise judgments.”

For the diagnosis and treatment of intracranial aneurysms, ArteryFlow Technology has launched a series of solutions. The AneuFlow® Intracranial Aneurysm Computer-Aided Diagnosis System is compatible with various imaging modalities, utilizes machine learning to assess aneurysm rupture risk, and completes critical clinical workflows. The AneuGuide® Real-Time Surgical Planning System for Intracranial Aneurysms provides gold-standard, rapid, and precise solutions for selecting flow diverter stent models and optimizing implantation positions, significantly improving interventional surgical outcomes while substantially reducing unnecessary consumable waste and costs. The AccuCTP® Automated Analysis System for Intracranial CT Perfusion Imaging fully automatically and accurately evaluates infarct volume and hypoperfusion volume, revolutionizing the assessment of ischemic stroke beyond the time window and saving patients' lives.

The aforementioned three products have all been approved by the National Medical Products Administration (NMPA). Meanwhile, the company has multiple other products in clinical trials.The interventional surgery planning software for intracranial aneurysms has passed the special review application for Class III innovative medical devices at the national level.ArteryFlow Technology is dedicated to providing comprehensive solutions for cerebrovascular diseases, covering the entire process of disease screening, diagnosis, and treatment. The company possesses the world's largest database for assessing aneurysm rupture risk, establishing a robust model foundation and competitive moat.

Following the same logic, in the field of cardiovascular disease, ArteryFlow Technology has launched non-invasive FFR-based products for assessing coronary artery stenosis using multi-modal imaging—including coronary CT, coronary angiography, IVUS, and OCT—as well as products for cardiac functional assessment.

Among them,The Coronary Angiography Functional Assessment System is the only product worldwide to have received certification from China’s NMPA, Europe’s CE, and the U.S. FDA., with a sensitivity 32% higher than similar products, its clinical efficacy has gained expert consensus and global recognition, and this technology is gradually being incorporated into treatment guidelines worldwide; the clinical validation accuracy of the AccuFFR®ct coronary CTA functional analysis system reached 92.1%, making ArteryFlow Technology the first company in China to offer coronary functional assessment products based on both coronary CT and angiography.

The aforementioned portfolio of flagship products validates ArteryFlow Technology’s corporate strategy of focusing on precision clinical care. By addressing the most critical needs in interventional cardiology and neurointervention, the company provides products and services tailored to the requirements of physicians and patients, earning a strong clinical reputation both domestically and internationally.

Furthermore, ArteryFlow Technology pioneered the “ArteryFlow online” academic forum under its ArteryFlow Academy in China, convening leading clinical experts nationwide to effectively disseminate the most advanced technologies, insights, and clinical progress in the cardiovascular and cerebrovascular fields, thereby accelerating industry-wide advancement. As a result, the company has solidified its robust clinical resources and gained significant momentum for clinical implementation.

As of now,ArteryFlow Technology has obtained NMPA, FDA, and EU CE certifications for 12 products, with dozens more currently undergoing regulatory approval in various countries.. The company’s one-stop, diversified industrial layout promotes the realization of precise and intelligent diagnosis and treatment for cardiovascular and cerebrovascular diseases in clinical practice.

ArteryFlow Technology’s product matrix effectively addresses the fundamental needs of all stakeholders. For physicians, ArteryFlow Technology does not merely focus on empowering a single segment; instead, the company provides imaging and hemodynamic evidence to assist doctors in determining whether disease intervention is necessary and how to deliver treatment efficiently. This approach enhances clinical capabilities, reduces reliance on individual physicians’ expertise and experience in diagnosis and treatment, earns patient trust, and boosts physicians’ professional reputation and academic publication output, thereby gradually fulfilling the need for broader accessibility of medical resources tailored to China’s healthcare system.

For patients, high-quality solutions covering both in-hospital and out-of-hospital scenarios facilitate early and standardized management of cardiovascular and cerebrovascular diseases, thereby achieving effective cure, accelerating recovery, alleviating treatment-related suffering, and significantly reducing disease-related costs and mortality rates. For hospitals, such solutions enhance overall medical standards and patient satisfaction, while promoting tiered diagnosis and treatment as well as local consultation services. For health insurance funds, they substantially reduce expenditures on overtreatment.

Xiang Jianping stated, “We encountered a patient with an aneurysm for whom the hospital initially proposed a surgical plan involving the placement of two flow-diverter stents. However, through hemodynamic analysis and surgical planning using our product, we found that placing only one stent would yield comparable outcomes. As a result, the patient saved the cost of one flow-diverter stent, and the procedural complexity and risks were reduced.”

ArteryFlow Technology’s ultimate goal is to build a global, end-to-end precision clinical ecosystem platform for cardiovascular and cerebrovascular diseases. Currently, ArteryFlow Technology is the only company capable of providing comprehensive solutions that encompass intelligent screening, testing, diagnosis, precision surgery, and treatment for cardiovascular and cerebrovascular diseases.

Artificial intelligence is accelerating its integration with healthcare, covering multiple scenarios such as disease screening, diagnosis, treatment, and patient management. However, the most mature application remains AI-based medical imaging, which typically addresses only the single step of disease diagnosis or focuses exclusively on cardiovascular or cerebrovascular diseases. In contrast, ArteryFlow Technology has achieved a differentiated strategic layout by providing comprehensive solutions for the diagnosis and treatment of cardiovascular and cerebrovascular diseases.

Unlike the horizontal expansion into interventional consumables for cardiovascular and cerebrovascular diseases, ArteryFlow Technology is pursuing in-depth development in the field of precision clinical care for cardiovascular and cerebrovascular conditions.

1. Extension of application scenarios based on the disease progression chain, enabling the use of clinically validated cardiovascular and cerebrovascular detection products in out-of-hospital settings to improve early screening and diagnosis rates. Leveraging its robust product capabilities and comprehensive end-to-end coverage, ArteryFlow Technology has partnered with the Health Examination Center of Zhejiang Hospital to conduct in-depth cardiovascular and cerebrovascular assessments outside hospital premises for disease management purposes.

By extending in-hospital services to out-of-hospital settings, ArteryFlow Technology has also expanded its target revenue market to include out-of-hospital medical imaging centers and high-end health checkup institutions. The company is on the verge of establishing deep collaborations, becoming the first enterprise in the industry to conduct business development outside hospitals. ArteryFlow Technology has taken the lead in engaging in exchanges and cooperation with multiple large enterprises, gradually capturing a share of the hundred-billion-yuan out-of-hospital testing market, expanding patient access channels, and enabling the general public to conveniently obtain comprehensive, in-depth cardiovascular and cerebrovascular screening services.

Second, high-end manufacturing based on existing algorithms,Achieving True Precision Medicine.ArteryFlow Technology is developing surgical robots, robotic arms, and other products applicable to intracranial and intracardiac interventions, with R&D and type testing phases now accelerating. The core of its surgical robots lies in software and algorithms, where optimizing image reconstruction, spatial registration, and positioning control within the system is critical—areas that constitute ArteryFlow Technology’s core competitive advantages.

By integrating ArteryFlow Technology’s comprehensive suite of screening, diagnostic, and therapeutic products for cardiovascular and cerebrovascular diseases, precise and refined treatment is achieved at the therapeutic end. This perfectly demonstrates the accuracy of upstream products, provides a complete, integrated solution, and realizes true precision clinical practice.

Xiang Jianping stated, “The extension of industrial layout is based on a company’s own expertise, evolving from an understanding of clinical practice into algorithms, and ultimately into software. Surgical robots are akin to autonomous vehicles; while many automakers now possess the capability to manufacture cars, the ultimate competition will undoubtedly center on algorithms and the overall coordination of the system.”

ArteryFlow Technology’s ability to achieve a diversified industrial layout is inseparable from its persistent adherence to the path of integrating medicine and engineering, supported by an in-house team dedicated to fostering scientific research collaborations. Meanwhile, ArteryFlow Technology has accumulated profound expertise in computational simulation, artificial intelligence, and medical imaging, with its team having published hundreds of academic papers.

Xiang Jianping, founder of ArteryFlow Technology, has many years of experience in hemodynamic research on cerebrovascular and cardiovascular diseases. He has published 115 academic papers and filed 64 patents, and established the RRS scoring system for predicting the risk of aneurysm rupture. Moreover, the company’s core team comprises experts in multiple fields, including medical imaging, hemodynamic simulation, and artificial intelligence, with R&D personnel accounting for more than half of the total workforce.

In December 2019, at the Innovation in Cardiovascular Interventions (ICI) conference held in Israel, ArteryFlow Technology’s non-invasive functional assessment product received the 2019 Best Cardiovascular Innovation Award. Subsequently, in December 2020, ArteryFlow Technology won first place for the Life Science and Technology Innovation Award at the 4th World Life Sciences Conference.It is evident that ArteryFlow Technology’s technologies and products are globally leading, laying a solid foundation for the company’s global expansion.

Currently, Chinese companies have insufficient global patent portfolios, with most exported medical devices being low- to mid-end products, lacking initiative in the high-end sector. In contrast, ArteryFlow Technology holds globally deployed patented technologies, and four of its products have already received overseas approvals, leading the industry’s international development.

With globally leading products in place, commercial implementation has become the top priority. Amidst industry-wide challenges in deployment and monetization, ArteryFlow Technology has pioneered a novel, multi-dimensional commercialization strategy, bolstered by the breadth and depth of its product portfolio and process coverage.

In less than a year, ArteryFlow Technology’s products have been adopted by more than 200 hospitals across over 30 provinces and municipalities in China, achieving comprehensive coverage of the country’s leading hospitals. With accelerated implementation and revenue surpassing RMB 10 million, the company has become a true pioneer in the commercialization of intelligent diagnostic and therapeutic solutions for cardiovascular and cerebrovascular diseases.The company simultaneously adopts a business model combining hardware sales with per-case and annual service fees. Leveraging its robust product matrix, it innovatively introduces the “Multi-Module Product Service Package,” offering diverse cooperation models tailored to the personalized needs of medical institutions, thereby significantly enhancing collaboration efficiency.

The company collaborates with renowned hardware enterprises such as Siemens and GE, integrating software and hardware to facilitate product implementation. It adopts a pay-per-clinical-case pricing model to reduce hospital procurement costs and drive sustainable sales. By leveraging internet hospitals, it provides more convenient and accessible diagnostic and treatment services to the public, unlocking the potential for large-scale sales. Furthermore, it has taken the lead in entering the out-of-hospital market, closely aligning with public needs and national policies.

In less than a year, ArteryFlow Technology has established an industry-exclusive large-scale ecosystem, integrating hospitals, patients, leading medical device manufacturers, third-party imaging centers, large enterprise clients, and industry associations to drive rapid industrial advancement and share in a trillion-yuan market.

The prevention and treatment of cardiovascular and cerebrovascular diseases are shifting from a previous focus on in-hospital care processes toward comprehensive, end-to-end management encompassing prevention, screening, diagnosis, and treatment both inside and outside hospitals. The establishment of an ecological closed-loop system for the full-spectrum management of cardiovascular and cerebrovascular diseases, driven by national-level early screening initiatives, represents an inevitable trend.

Comprehensive management of patients with cardiovascular and cerebrovascular diseases should be physician-led, extending from treatment to early screening, diagnosis, and long-term follow-up, while spanning both in-hospital and out-of-hospital settings to ultimately promote early screening, early diagnosis, and collaborative diagnosis and treatment. To build a one-stop ecosystem platform for cardiovascular and cerebrovascular diseases, enterprises need not only technology and products, but more importantly, solutions that address genuine clinical needs, access to clinical resources, close engagement with clinical practice, and high levels of clinical recognition. Only in this way can companies facilitate high-quality interactions between physicians and patients, thereby achieving truly patient-centered care.

ArteryFlow Technology has developed along this path, pioneering the world’s first precision clinical ecosystem platform for cardiovascular and cerebrovascular diseases. Building on its two core product pipelines in precision clinical care for cardiovascular and cerebrovascular conditions, ArteryFlow Technology continues to develop new products, advance the clinical application and regulatory registration of its existing intelligent diagnostic and therapeutic solutions, and expand its R&D and marketing teams. Meanwhile, the company is actively engaging in clinical collaborations and academic conferences, with plans to partner with more top-tier hospitals both domestically and internationally.

Reference Article:

[Expert Dialogue] Pan-Vascular Full-Course Management Opens a New Chapter, with Innovative Drugs Empowering High-Quality Industry Development — China.org.cn Medical Channel

"Report on Cardiovascular Health and Diseases in China 2020"