Home Xin Fangyue Medical: China's Only Non-Invasive FFRct Solution for Coronary Artery Disease Achieves 77% Diagnostic Accuracy

Xin Fangyue Medical: China's Only Non-Invasive FFRct Solution for Coronary Artery Disease Achieves 77% Diagnostic Accuracy

Oct 31, 2016 08:00 CST Updated 08:00

According to statistics, the number of prevalent cases of cardiovascular disease in China is 290 million, with 2 out of every 10 adults suffering from cardiovascular disease. Approximately 350Ten thousandHumanDue to cardiovascularDisease Incidence and Mortality. The accuracy of disease screening for patients in cardiovascular outpatient clinics at the current stage is50%-60%PatientRequiredDoMultipleOutpatient Examination,Prolonged Examination Duration and High Costs, cardiovascular medical services are far from meeting the growing number and needs of patients with cardiovascular diseases.


Alongside the vast number of patients, there is a shortage of physicians, particularly in underdeveloped regions where experienced doctors are limited. Consequently, most percutaneous coronary intervention (PCI) treatment plans are suboptimal, prompting many patients to seek care in eastern China, which significantly increases both time and financial costs.


Xinfangyue FFRct leverages this vast population of cardiovascular disease patients to provide them with the world’s most advanced non-invasive auxiliary diagnostic technology for myocardial ischemia in coronary heart disease (FFRct). It confirms whether patients with coronary heart disease have myocardial ischemia, assists physicians in planning percutaneous coronary intervention (stent) and coronary artery bypass grafting (CABG) surgeries, and delivers accurate and effective interventional treatment strategies.The diagnostic accuracy rate in current clinical trials has reached 77%.


Original Technology for Non-invasive Auxiliary Diagnosis of Myocardial Ischemia in Coronary Heart Disease (FFRct)


Xinfangyue Medical was established in 2014. Its founder, Cheng Yue, holds a Master’s degree in Computer Engineering from Beijing University of Posts and Telecommunications and an MBA in International Business Administration from Guanghua School of Management, Peking University. He has previously worked at China Unicom Headquarters, Lucent Technologies Bell Labs, and Linkage Software Technology Co., Ltd., among other Chinese and foreign enterprises, establishing himself as an expert in both technology and business management.


Tang Tiebing, the company’s co-founder and CTO, is a renowned technical expert. He has previously held positions at the Institute of Software, Chinese Academy of Sciences; Integrix (USA); IBM China Development Lab (CDL); iQstor’s China Technology Department; NetentSec; Landi Beijing (Taiwan); and Websense China. In addition to its strong technical leadership, the company has assembled a team of experts in medicine, radiology, and mechanics to jointly develop its products.


Cheng Yue told a reporter from VCBeat (WeChat ID: vcbeat) that their team members all have technical backgrounds. After witnessing the advantages of FFRct technology in the United States in 2013 and recognizing that the screening and diagnosis of small vessel diseases in China lagged behind, they decided to devote themselves to technological innovation in FFRct. Their goal is to enable people in China to benefit from new technologies that provide more convenient and accurate medical services.


Xinfangyue FFRct: Non-invasive Diagnostic Software for Coronary Artery Disease and Pre-operative Assessment for Stenting and Bypass Surgery, which breaks away from traditional invasive inpatient examinations. By integrating hemodynamics, medical imaging, and other multidisciplinary fields, and leveraging patient-specific physiological parameters, it innovatively enables precision and personalized medicine for coronary artery disease.


FFRct Workflow


The physician uploads medical imaging data to the data center. The Xin Fang Yue FFRct software processes CT images to construct three-dimensional models of the heart and coronary arteries. Based on hemodynamic principles, it automatically calculates and analyzes changes in fractional flow reserve (FFR) caused by lesions (note: FFRct > 0.8 indicates no ischemia; FFRct < 0.8 indicates ischemia), and evaluates the improvement in myocardial ischemia following stent implantation or bypass surgery. By providing accurate imaging and clear visualization of stenosis severity and lesion extent, the system intelligently addresses the assessment of optimal treatment strategies for stent implantation or bypass surgery, and finally transmits the FFRct results to the physician.


Four Technologies Build a Moat


Cheng Yue told reporters that the company’s current strengths lie primarily in four technological advantages, namely:3D Coronary Artery Image Reconstruction, Medical Big Data, AI-Assisted Diagnosis of Myocardial Ischemia (FFRct), Mobile Imaging, and Remote Diagnosis


Three-Dimensional Reconstruction of Coronary Artery Images: Cardiovascular vessels have small diameters and complex tree-like branching patterns. Traditional image segmentation methods yield suboptimal results and require extensive manual interaction, failing to meet the demands of clinical diagnosis. The coronary artery 3D image reconstruction technology, developed by the Xinfangyue technical team in collaboration with Beijing University of Posts and Telecommunications, is based on medical imaging DICOM data files. It employs image processing techniques to segment the myocardium and coronary arteries, generating a complete coronary artery tree and automatically labeling vascular morphological parameters (such as degree of stenosis, lumen diameter, area, and ventricular volume) for reference by clinicians. This technology has currently been granted multiple patents.


Medical Big Data: The Xinfangyue team conducts statistical analysis of medical data from healthy individuals and patients with coronary heart disease (CHD) provided by partner hospitals, including gender, age, blood pressure, heart rate, medical history, electrocardiogram (ECG), ultrasound, CT, angiography, fractional flow reserve (FFR), stenting, and bypass surgery. Based on this data, the team establishes patient-specific physiological parameter models (such as blood flow velocity, pressure, and resistance) to build a CHD diagnostic knowledge base. This enables cardiovascular lesion prediction for healthy populations (e.g., degree of vascular stenosis and risk of myocardial ischemia) and rapid screening and diagnosis for suspected patients (e.g., severity of myocardial ischemia).


Myocardial Ischemia Auxiliary Diagnosis (FFRct): This technology is primarily used for early screening and diagnosis, preoperative planning, and postoperative assessment. By employing computational fluid dynamics to accurately simulate blood flow velocity and pressure distribution in the coronary arteries, it replaces current high-cost invasive diagnostic methods, thereby revolutionizing the diagnostic workflow for coronary artery disease.


Traditional, complex screening methods—such as non-invasive echocardiography, radionuclide myocardial perfusion imaging, magnetic resonance imaging (MRI), and invasive coronary angiography and fractional flow reserve (FFR)—can be replaced by computer simulation calculations based on CT images. This approach not only improves diagnostic accuracy, preventing missed diagnoses and overtreatment, but also reduces patient discomfort and societal healthcare expenditures.


Xinfangyue Medical has independently developed the innovative “Xinfangyue FFRct Diagnostic Software,” which is protected by national software copyright. It provides patients and physicians with a new non-invasive diagnostic approach for ischemic lesions in coronary artery disease.


Mobile Imaging and Remote Diagnosis: Users (physicians or hospitals) upload imaging files to the Xinfangyue Data Center via an internet-based web interface. The data center processes and analyzes the images to generate a report on cardiovascular lesions. Experts from Xinfangyue’s departments of cardiology, cardiac surgery, and radiology also provide consulting services, offering remote support for image analysis results or addressing users’ specific needs (such as film interpretation).


Xinfangyue Medical’s mobile medical imaging consultation platform has obtained a Software Copyright Certificate issued by the National Copyright Administration of China. Xinfangyue’s data center is deployed and operated outside hospitals, directly serving hospitals and physicians through a remote service model.


The product serves both doctors and patients.


Doctors in China all have research needs; Xinfangyue relies on its four core technologies,Provide technical support for scientific research collaboration to physicians in the field of cardiovascular diseases. Typically, physicians establish research projects, with Xin Fangyue providing technical support to help them complete their studies. Meanwhile, Xin Fangyue’s products assist physicians in diagnosis and in planning vascular stent and bypass surgeries, thereby delivering accurate and effective interventional treatment plans for patients.


Primarily Provides for PatientsRemote Consultation and Sudden Cardiac Death/Cardiovascular Disease Screening Services. Remote consultation allows patients to undergo local examinations and upload the results to the company’s platform, where Xin Fangyue’s software and expert team provide diagnoses. If surgery is required, an optimal treatment plan will be offered, with therapeutic outcomes pre-simulated via computer modeling.


Sudden Cardiac Death/Cardiovascular Disease Screening ServiceTargeting high-risk individuals aged 40 and above for cardiovascular diseases, this service is jointly provided by the company and Beijing Shanfang International Hospital. Xin Fangyue’s FFRct technology offers non-invasive screening, delivering results within one day with an accuracy rate of 77%, stated Cheng Yue.Next year, Xinfangyue Medical plans to increase the accuracy rate to 80% and reduce the report turnaround time to 2–5 hours.


The Seven Key Values of Xinfangyue FFRct


Technical advantages inevitably lead to greater value. Cheng Yue introduced to reporters the value of Xinfangyue in seven aspects, including cost reduction, improved accuracy, shortened medical consultation time, and telemedicine.


1. Xinfangyue FFRct-Assisted Interventional Therapy Reduces Stent Implants by an Average of 0.8 per Patient; and significantly reduce the one-year mortality rate among patients with coronary heart disease after treatment by approximately 17%. Based on an annual volume of 500,000 percutaneous coronary interventions in China, this would save more than RMB 7 billion per year in costs for stent materials, hospitalization, and treatment. This approach reduces unnecessary expenditures from social insurance and simultaneously lowers postoperative complications and mortality associated with overtreatment.


2.Xinfangyue FFRct: Non-invasive Detection and Diagnostic Method, Scalable for Widespread Adoption at the Outpatient Stage. For every 1,000 per yearof outpatient visits, which can improve the admission screening rate for patients with genuine coronary heart disease. This enables effective diagnosis at the outpatient stage for patients who would otherwise require hospitalization and surgery for confirmation, thereby reducing unnecessary occupation of hospital resources by patients who do not actually need inpatient treatment and improving the efficient utilization of medical resources.


3. Xin Fangyue FFRct can significantly improve diagnostic accuracy compared to existing diagnostic methods such as coronary angiography and coronary CT.In terms of sensitivity, FFRct is 20% higher than coronary angiography; in terms of specificity, FFRct is 45% higher than coronary CT!


4.Xinfangyue FFRct Diagnosis Can Reduce Patients' Diagnostic and Treatment Costs: Non-invasive diagnosis eliminates the need for hospitalization required by conventional FFR, thereby reducing diagnostic costs. Virtual stenting and preoperative planning and assessment for bypass surgery enabled by FFRct can significantly reduce the number of stents implanted, lower unnecessary patient expenditures, and improve the efficacy of stent implantation and bypass surgery. This approach substantially reduces postoperative mortality and complication rates, thereby lowering subsequent treatment costs for patients.


5. FFRct reduces ineffective waste of medical resources and lowers patient diagnosis and treatment costs by increasing the screening rate, trulyIt can improve the efficiency of social security fund utilization, ensuring that patients who truly need treatment gain access to medical resources.


6. Xinfangyue FFRct diagnosis can provide physicians with an objective, quantitative diagnostic result, thereby enhancing their diagnostic capabilities. Meanwhile, during large-scale implementation of Xinfangyue FFRct diagnosis, the growing wealth of case data can be leveraged toDiagnostic accuracy has increased from the current 50%-60% to approximately 77%.thereby providing physicians with a tool for shared learning.


7. XinFangYue FFRct adopts a SaaS cloud service model to provide consistent, uniformly priced services across all regions of China, enabling economicUnderdeveloped regions enjoy access to the same advanced technical services as developed regions.


Profit Model and Investment & Financing


Currently, Xinfangyue Medical’s revenue is primarily derived from research service fees charged to physicians and surgical planning service fees charged to patients. The company’s business operations mainly cover Beijing, Hebei Province, Inner Mongolia, and other regions. It currently provides surgical treatment plans for approximately 20–30 patients per month.


According to Cheng Yue, the company will establish two physical operational centers in Beijing and Shanghai next year, with a plan to provide 1,000 surgical treatment plans per month. The company is currently undergoing its angel round of financing.