China’s cardiovascular disease (CVD) patients have reached 330 million, and two out of every five deaths are due to CVD. This is the data in China’s Cardiovascular Health and Disease Report 2022 (hereinafter referred to as Report 2022), which was released by the National Center for Cardiovascular Disease at the end of June. The data in the report also shows that the morbidity and mortality rates of cardiovascular diseases in China are still rising, and the inflection point of the decline in the burden of cardiovascular diseases has not yet appeared.
However, cardiovascular diseases often have a long “latency period” from initiation to onset. For example, an important feature of coronary heart disease is sudden, direct myocardial infarction or even sudden death. How can these 330 million patients take precautions in advance to reduce the morbidity and mortality of CVD? In addition to improving dietary structure and adopting good living habits, routine diagnosis & screening is also one of the “tools”.
However, electrocardiogram (ECG), cardiac ultrasound and other means are unable to detect early coronary heart disease and other sudden-onset diseases, while coronary flow reserve fraction (FFR), CT angiography (CTA), coronary angiography (CAG), and nuclear medicine (SPECT) and other technologies, although more widely used in clinical applications, have high examination costs, radiation risks, invasive operations and other problems, and are not entirely suitable for routine outpatient diagnosis and screening. It is not completely suitable for routine diagnosis and screening of outpatients.
So, how can we achieve “prevention-oriented and grassroots-oriented”, and monitor CVD during the “latent period” by a safer, more effective and precise means? With the continuous development of medical technology, new diagnostic techniques are emerging, and magnetocardiography (MCG) is one of the solutions.
As a cardiac function test that detects the magnetic field of the human heart for imaging and analysis, MCG does not require electrodes to be attached to the surface of the body or drugs to be injected, and can be performed non-invasively under clothing. The patient only needs to remove the metal objects on the body, and then connect the electrode clips to the wrists and ankles, and then the sensors on the upper part of the chest will automatically record the magnetic field of the cardiac cycle and quickly image it. The biggest difficulty of this technology is how to accurately detect the weak cardiac magnetic signals at the limit of millions of times the earth’s magnetic field, and process them accurately and quickly.
Aiming at the above industry pain points, Cardiomox has enhanced the sensitivity of the instrument’s detection and the precision of software processing through the R&D and innovation of software and hardware technologies, breaking through the interference of the earth’s high magnetic field, so that the cardiomagnetic mapper can detect the cardiac magnetic signals in an ordinary environment.
Specifically, Cardiomox’s innovative advantages can be divided into the following four points:
- First, it adopts superconducting quantum interferometer with high detection accuracy.
Although magnetic field exists in any space and any substance, the magnetic field generated by human heart is very weak, especially in the ischemia-sensitive ST segment of the heart, which is one millionth of the earth’s magnetic field. Therefore, the magnetic sensor for cardiac magnetic detection is the core component of the magnetometer, which is also the key to the detection performance of the device. - Second, the exclusive noise shielding patented technology, without magnetic shielding room can measure the cardiac magnetic signal.
Magnetometers using superconducting quantum interferometers often need to be detected in a magnetically shielded room (MSR) to exclude interference from the earth’s magnetic field, but magnetically shielded rooms are expensive and cover a large area, ranging from dozens of square meters, which creates a major obstacle to the introduction of hospitals that are originally tight on space, as well as hospitals that are unable to renovate their old hospital areas. To address this pain point, Cardiomox integrates a second-order gradiometer, advanced computer algorithms, and exclusive patented noise shielding technology with the magnetometer, so that the device does not need to be shielded, and can extract cardiac signals from the powerful geomagnetic environment in a separate room of only 10-20 square meters. This improves detection accuracy while also helping to popularize the landing of the magnetocardiogram technology. - Third, the composite analysis method based on the time domain and frequency domain improves the information content and usability of the cardiac magnetic signal.
The advantages of the hardware allow the cardiac magnetic field to be captured by the device, but this process will inevitably record other magnetic field signals from different sources and orders of magnitude in the environment, and the quality of the signal directly affects the effectiveness of the later clinical analysis. Therefore, how to extract them completely and efficiently from the background noise is the biggest challenge on the algorithm side. Compared with the cycle superposition technology and industrial frequency filter used by traditional devices, Cardiomox adopts a composite analysis method based on the time domain and frequency domain, and combines the relevant theories of modern digital signal processing, so that the device significantly improves the signal-to-noise ratio at the same time, and carries out theoretical analysis and simulation demonstration of the signal characteristics that can easily be ignored, so as to further improve the information quantity and usability of the cardiomagnetic signals - Fourth, the AI diagnostic software covers six major application scenarios to assist doctors in rapid diagnosis. Based on the entropy value optimization algorithm of AI, the diagnostic software can process and analyze the collected cardiac magnetic signals, and automatically differentiate between mild and severe diseases without manual interpretation. The software not only provides doctors with preliminary results that can be used for clinical diagnosis, but also improves the diagnostic speed, accuracy and reliability that must be faced when commercializing the product. In addition, Cardiomox’s AI diagnostic software can record a database of information about the person to be tested, and query the real-time acquisition of cardiac magnetic signals, data processing, imaging analysis, parameter analysis and diagnostic reports, as well as historical records and results.
Up to now, Cardiomox has obtained registration certificates for two models of magnetocardiographs, namely Cardiomox MCG 9 and Cardiomox MCG 12. In addition, the company is also developing the next generation of magnetometers with smaller size and smarter diagnostic software.
Cardiomox, as a national high-tech enterprise planned and facilitated by Oxford University Innovation (OUI) in 2016, is one of the first high-tech projects incubated by Oxford University in China. The company’s magnetocardiography technology comes from the Institute of Automation of the National Academy of Sciences of Ukraine, which is known for its magnetic detectors against ultra-quiet nuclear submarines.
Xu Lin, general manager of Cardiomox, said that while Cardiomox has an advanced technology base, it is also equipped with a high-end medical device R&D, management and industrialization team with international advanced level. The core members of the team have been engaged in the development and research of magnetometers for more than 30 years, and they are also the first group in the world to develop magnetometers. The chairman and founder of Cardiomox, Mr. Feng Xie, holds a master’s degree in engineering science from Oxford University and has been engaged in management and market development for nearly ten years. He is a serial entrepreneur in the medical device industry with many successful experiences, and has rich experience in team formation, introduction and digestion of high-end technology, and production line setup.
After years of deep cultivation in the field of magnetocardiography, the company now owns more than 20 domestic and international intellectual property rights, and in November 2020, the company obtained the registration certificate of the first nine-channel magnetocardiograph in China, and within one month after obtaining the certificate, the company completed the first sale of the magnetocardiograph in the Eighth People’s Hospital of Guangzhou City. As one of the latest and most advanced technologies in the field of non-invasive cardiac examinations, the magnetocardiograph can provide testing support for a number of application scenarios in the Department of Cardiology of public hospitals, medical checkups, chest pain centers, and other institutions.
First of all, the magnetometer can be used for the identification of early coronary artery disease and the diagnosis and differential diagnosis of cardiomyopathy in the cardiology department of hospitals, the monitoring of people at high risk of heart disease and the assessment of heart health status in medical check-up organizations, as well as the rapid triage of acute cardiovascular diseases and the exclusion of non-heart disease patients in chest pain centers.
As a highly sensitive, non-invasive and convenient means of detection, the magnetometer can also be used in some special scenarios, such as the daily assessment of the heart condition of astronauts, athletes, long-distance drivers and other special people, as well as the monitoring of the therapeutic effects of pharmaceutical and medical device companies, such as monitoring before and after cardiac interventional surgeries and drug therapy, and the assessment of the effects of drug therapy for coronary artery disease.
Although the application scenarios are diverse, as an innovative device whose popularity is not as high as that of ECG, how can the magnetocardiograph land in the clinic, efficiently assist doctors in diagnosis, and improve the accuracy of AI diagnosis? This is a difficult problem that enterprises have to face in the process of device promotion and commercialization.
As an enterprise incubated by the University of Oxford, Cardiomox has built cooperation platforms with many universities at home and abroad since its establishment, such as the University of Oxford, the University of Manchester, and North University of China, in order to promote the continuous innovation of the technology and basic scientific research in the field of cardiac electrophysiology.
In order to better meet the clinical needs and accelerate the promotion of the device, the company has accumulated more than 20,000 domestic and international cases based on the collection and collation of clinical data from domestic and international patients, and has simultaneously established a standard case atlas as well as 13 typical heart disease cardiac magnetic atlas.
Currently, the country has set up a 14th Five-Year Plan special program for magnetocardiography to establish a set of diagnostic guidelines common to all magnetocardiography products. The guidelines are expected to be officially released in 2024. In addition to the strategic leadership at the national level, some provinces and municipalities have also introduced fees for a single test of magnetocardiography.
With the strong support of the state and governments at all levels, magnetometer will be promoted and applied at a faster pace, reducing the pain of later treatment and lowering the economic burden through early intervention, benefiting the majority of heart disease patients.
Early detection and treatment is the key to reduce the incidence of cardiovascular and cerebrovascular diseases, Cardiomox’s magnetometer has a good application prospect in early screening, diagnostic evaluation and long-term monitoring of cardiovascular diseases, etc. The company will continue to lay out the innovative industry, and is committed to exploring the cardiac magnetism, cerebral magnetism detection technology, and fetal heart monitoring technology in the field of medical research and industrial promotion.