Shengshi Medical Technologies Files for IPO, Pioneering Non-Invasive Cardiovascular Screening with AI-Powered FFRct Platform

In 2018, five medical device companies worldwide secured over $100 million in financing: PROCEPT BioRobotics ($118 million), HeartFlow ($150 million), Outset Medical ($132 million), Butterfly Network ($250 million), and Auris Health ($220 million), which was subsequently acquired by Johnson & Johnson for $3.4 billion.

Among them, PROCEPT and AURIS are surgical robot manufacturers, Butterfly focuses on handheld ultrasound devices, and Outset manufactures compact home dialysis machines. Unlike the aforementioned hardware manufacturers, HeartFlow is the only software-based diagnostic company in this group. HeartFlow is dedicated to using artificial intelligence technology to measure fractional flow reserve (FFR) of coronary arteries, enabling non-invasive diagnosis of coronary artery disease.

Currently, HeartFlow has raised a total of $467 million from investors such as GE Ventures, Wellington Management, and BlueCross BlueShield Ventures, with its latest valuation standing at $1.5 billion.

Founded in 2009, HeartFlow has rapidly emerged as a unicorn in the healthcare sector. Yet little known is the fact that Charles Taylor, the founder of this company that revolutionized the diagnosis of coronary artery disease, did not initially work in medicine. In the 1990s, Taylor was engaged in aerospace research, studying the effects of wind on aircraft wings.

Coincidentally, a Chinese company benchmarking itself against HeartFlow also has a founding team with backgrounds in the aerospace industry. Established in 2017, SHENGSHI TECHNOLOGY CO. LTD has, in less than two years, initiated collaborations with multiple Grade 3A hospitals across China.

Huang Sitai, Chief Operating Officer of SHENGSHI Technology, told VCBeat that their decision to launch a venture in the field of non-invasive imaging screening for coronary heart disease was driven by the unmet needs in this area and the promising opportunities and potential of interdisciplinary integration between medicine and engineering.

Cardiovascular and cerebrovascular diseases are the leading cause of death worldwide. Data released by the National Health Commission shows that cardiovascular diseases account for more than 40% of all deaths. In addition to high mortality, cardiovascular diseases are also characterized by high rates of disability and prevalence. Even with the most advanced and comprehensive treatment methods available today, more than 50% of survivors of cardiovascular and cerebrovascular events remain unable to fully care for themselves.

According to World Health Organization statistics, up to 15 million people worldwide die from cardiovascular and cerebrovascular diseases each year. In China, the number of patients with cardiovascular disease has reached 290 million, including 11 million patients with coronary heart disease.

Coronary heart disease is a silent killer lurking among us. To achieve faster and more precise diagnosis, scientists have traversed a long and arduous path. In 1959, Dr. Sones, a pediatrician at the Cleveland Clinic in the United States, discovered coronary angiography (DSA). Since then, coronary angiography has become the “gold standard” for diagnosing coronary heart disease.

Coronary angiography involves puncturing the radial artery at the wrist, advancing a guidewire into the coronary arteries of the heart, and then injecting contrast media to visually assess the filling of the various coronary vessels. The presence of filling defects indicates stenosis caused by plaque buildup. Based on the severity of the stenosis, the physician then determines whether stent implantation is necessary to dilate the vessel.

Currently, the diagnosis of coronary heart disease is based on the criterion of ≥50% luminal stenosis as shown by coronary angiography.

Coronary angiography is the “gold standard” for diagnosing coronary heart disease, but it is not the sole diagnostic method. Other techniques, such as coronary computed tomography angiography (CTA), intravascular ultrasound (IVUS), and fractional flow reserve (FFR) measurement, can also be used to diagnose coronary heart disease.

Coronary CTA visualizes the course and degree of stenosis of blood vessels through CT angiography and computer-based three-dimensional reconstruction. Coronary CTA can partially replace coronary angiography, but its accuracy is not high.

The issue with intravascular ultrasound (IVUS) imaging technology is that it remains prohibitively expensive.

Fractional Flow Reserve (FFR) was introduced in the 1990s, and its emergence began to challenge the diagnostic criteria for coronary artery disease based on coronary angiography.

FFR refers to the ratio of the maximum blood flow that can be obtained in the myocardial region supplied by a coronary artery with stenotic lesions to the theoretical maximum blood flow that would be obtained in the same region under normal conditions.

Unlike coronary angiography, which only visualizes the degree of luminal stenosis, fractional flow reserve (FFR) can assess the actual impact of the stenosis on distal blood flow. Furthermore, FFR accurately evaluates the relationship between coronary lesions and myocardial ischemia, thereby guiding rational treatment decisions and improving patient prognosis.

The reason why FFRct technology has gained significant popularity lies in its use of algorithms to replace pressure wire-based intravascular intervention. By ensuring accuracy, it transforms invasive diagnosis into non-invasive diagnosis.

Huang Sitai told VCBeat, “SHENGSHI’s products are capable of performing 3D organ reconstruction and coronary artery extraction after acquiring CTA images, ultimately calculating FFRct.”

Research data published in the Journal of the American College of Cardiology in 2014 indicated that FFRct had a higher diagnostic accuracy (86%) than coronary angiography (65%), and its specificity was significantly improved compared with coronary CTA (60%).

Compared with traditional methods using catheters and pressure guidewires, FFRct can also reduce the overall diagnostic cost of coronary artery disease.

Huang Sitai stated, “A patient undergoing a CTA scan at a hospital will be charged between 2,000 and 3,000 yuan, depending on the institution. If the diagnosis remains inconclusive, a DSA procedure is then performed, costing between 6,000 and 7,000 yuan. To achieve a more precise diagnosis, pressure wire measurements are required during the DSA. However, the cost of this single pressure wire alone is approximately 10,000 yuan.”

It is calculated that patients need to bear a cost of approximately 20,000 yuan before even entering the surgical stage.

Huang Sitai further explained, “FFRct can streamline the diagnostic and treatment workflow following CTA imaging. After acquiring CTA data, hemodynamic parameters that would otherwise require wire-based measurement can be calculated directly on our workstation.”

Similar to the founders of HeartFlow, the core team at SHENGSHI TECHNOLOGY CO. LTD also has a background in aerospace. Founder Gao Qi is an expert in fluid dynamics, an associate professor at the School of Aeronautics and Astronautics, Zhejiang University, and holds a Ph.D. in Aerospace Engineering and Mechanics from the University of Minnesota, USA. He has long been engaged in research on hemodynamics.

The core team also includes other members with in-depth expertise in hemodynamics. Wei Runjie, CTO of SHENGSHI Technology, holds a Ph.D. from Beihang University and has been engaged in fluid mechanics research for 20 years. Wu Peng, another core team member, earned his master’s degree from Tsinghua University and his Ph.D. from KU Leuven in Belgium, and currently serves at the Institute of Artificial Organs, Soochow University. Huang Sitai, COO, graduated from Hamamatsu University of Tokoha Gakuen in Japan, majoring in International Economics.

Supported by a robust technical team, SHENGSHI science and technology has achieved breakthrough results with its FFRct product. While HeartFlow’s product received FDA approval in 2014, its algorithm requires 4–5 hours to generate results. In contrast, SHENGSHI science and technology has developed a rapid algorithm based on AI-powered image recognition and hemodynamic analysis, capable of delivering results within 5–10 minutes.

In addition to improving speed, SHENGSHI science and technology validated the accuracy of its measurements by comparing its product with existing clinical CTA data and pressure wire data. The data demonstrated that the sensitivity and specificity of SHENGSHI’s FFRct product both exceed 90%.

In terms of business model, HeartFlow has adopted a cloud computing approach. Huang Sitai believes that implementing this model in China presents significant challenges.

He stated, “Adopting a cloud-based model in hospitals involves issues such as data security and patient privacy. Furthermore, HeartFlow requires professional fluid dynamics engineers to perform computations, whereas the rapid algorithm developed by SHENGSHI does not. Therefore, our algorithm can be deployed and run within the hospital.”

During the research and development and clinical trial phases, SHENGSHI science and technology has established in-depth collaborations with leading domestic hospitals, including Sir Run Run Shaw Hospital of Zhejiang University, West China Hospital, Fuwai Hospital, and Zhongshan Hospital Fudan University.

In addition to its FFRct product, SHENGSHI is developing hemodynamic assessment products for heart valves and the aorta, focusing on common valvular heart diseases and critical aortic dissection. The mainstream imaging modalities for diagnosing valvular heart disease and aortic dissection are ultrasound and CT. While ultrasound provides real-time imaging, it offers limited spatial distribution and precision. In contrast, CT lacks hemodynamic information and only provides static images.

Currently, there are no conventional clinical techniques capable of comprehensively assessing valvular and aortic hemodynamics. SHENGSHI Technology leverages MRI data to extract blood flow information for hemodynamic analysis. By reconstructing intravascular velocity, pressure, and wall shear stress within the cardiovascular system, it provides solutions for diagnosing valvular diseases, evaluating surgical plans, and screening high-risk populations for aortic dissection.

In addition to hospitals, SHENGSHI has also partnered with multiple major imaging equipment manufacturers to pave the way for future commercialization.

Huang Sitai revealed to VCBeat that SHENGSHI TECHNOLOGY CO. LTD is currently undergoing external financing.