Magnetic Insight Medical: Pioneering Domestic Innovation in Biomagnetism for Over a Decade, Aiming to Lead the Global Biomagnetic Field

Cardiovascular and cerebrovascular diseases are known as the “number one killer” of human health. In recent years, rapid and precise diagnosis of these conditions has become a key focus for research and breakthroughs in global medical technology. According to the Report on Cardiovascular Health and Diseases in China 2021, both the prevalence and mortality rates of cardiovascular diseases in China are on the rise. It is estimated that there are currently 330 million patients with cardiovascular disease, with two out of every five deaths attributable to such conditions. The large patient population and substantial healthcare burden underscore the critical importance of advanced diagnostic and therapeutic technologies for cardiovascular diseases.

Recently, a non-invasive novel functional testing device for myocardial ischemia—MagnetocardiographGarnering significant attention from both the clinical community and the industry. However, due to barriers such as technology and capital constraints, only a handful of domestic companies are committed to the research and development of magnetocardiography (MCG) systems. Recently, VCBeat interviewed the company that became the first in China to obtain regulatory approval for MCG equipment.Mandy Medical Instruments (Shanghai) Co., Ltd.(hereinafter referred to as"Mand Medical"), and with the companyGeneral Manager, Zhang Shulin, Shanghai Institute of Microsystem and Information Technology, Chinese Academy of SciencesResearcherWe discussed Mandi Medical’s development history and strategic plans, as well as its assessment of industry trends.

Mandee Medical, established in 2009, is composed ofExperts from the Shanghai Institute of Microsystem and Information Technology, Chinese Academy of SciencesandReturning ScientistsJointly established, focusing on the research and development, production, and sales of biomagnetic devices, with a commitment to becoming a leading enterprise in the international field of biomagnetic research.

Since its establishment, Mandi Medical has remained committed to independent technological innovation. After more than a decade of arduous technical breakthroughs, it has finally broken through foreign technological barriers and mastered domestically produced magnetocardiography (MCG) detection technology with full independent intellectual property rights. The performance of its equipment has reached an internationally advanced level, and inIn 2019, it became one of the first manufacturers in China to obtain NMPA registration certificates for magnetocardiography devices.

Mand Medical Magnetocardiography System Product Image

Researcher Zhang Shulin told VCBeat that the magnetic field generated by the electric currents formed by ion flow within cardiomyocytes is called the magnetocardiogram (MCG). The MCG instrument is a functional imaging method that uses ultra-high-sensitivity magnetic detectors to detect and analyze the magnetic field signals of the human heart. The magnetic field signals of the heart are extremely weak, with an intensity generally on the order of tens of picoteslas (10^-12T), equivalent to one millionth of the Earth's magnetic field. Although the magnetocardiographic signal is weak, it is not subject to interference from other tissues such as the chest wall and pericardium. By recording parameters including the direction, distribution, and dynamic changes of the magnetocardiographic vector, it is possible to conduct a multidimensional assessment of the cardiac electrical activity process, yielding more objective and comprehensive information.It possesses inherent advantages in terms of technical principles.

However, accurately and reliably measuring weak cardiac magnetic fields amidst the complex electromagnetic interference of the real world is akin to finding a needle in a haystack. At that time, the industry’s solution was to invest millions in constructing magnetically shielded rooms. Yet the prohibitive costs of construction and maintenance deterred countless hospitals.

To address this pain point, Mandi's magnetocardiography system employs ultra-high-sensitivityLow-Temperature Superconducting Quantum Interference Device (SQUID)As a magnetic field detector, it can detect signals at the fT level (10^-15T) magnetic signals, and throughMagnetic Environment Compensation, Environmental Noise Suppressionincluding multiple breakthroughs in independently developed patented technologies, completing magnetocardiography scanning examinations under fully electric control, which canGeneral outpatient settings without magnetic shielding, enabling precise acquisition of weak magnetocardiographic signals.

When using Mandi Medical’s magnetocardiography system, patients need only remove any metallic items on their person and lie relaxed and supine on the scanning bed. Healthcare professionals adjust the position of the magnetic field detection array without contacting the patient’s body, and the magnetocardiograph automatically acquires cardiac magnetic field data.to the human bodyNon-invasive, radiation-free, and completely harmless., throughout the entire processQuiet, noise-free, and vibration-free,OnlyThe test can be completed in 5-10 minutes.

Schematic Diagram of Mandi Medical’s Magnetocardiography System Operation

During acquisition, through Mindray Medical's self-developedFull-Spectrum Dynamic and Fully Automated Quantitative Analysis Software, enabling real-time tracking and display of magnetic field and current images throughout the complete cardiac cycle, as well as spatial and temporal domain information on cardiac magnetic function, thereby formingVisualized magnetic field maps, current maps, cardiac electrical activity trajectories, and vector parameter diagrams. AI algorithms developed through the accumulation of long-term data can enable magnetocardiographyIntelligent Analysis and Examination Result Alerts、Assisting Clinical Experts in Interpretation、Issue an examination report.

AI-Assisted High-Precision Intelligent Diagnosis of Magnetocardiography

Currently, Mandi Medical has partnered withDirector Shen Chengxing, Shanghai Sixth People's HospitalTeam Collaboration, Shared AccumulationOver 3,000 clinical cases.Compared with coronary angiography, the sensitivity of magnetocardiography in diagnosing myocardial ischemia is as high as94%The above specificity reaches92%. Meanwhile, the team also conducted research on the application of magnetocardiography in the diagnosis of coronary microvascular dysfunction (CMVD), and establishedDiagnostic Prediction Model for CMVD, with a sensitivity of89.57%, with a specificity of84.81%, opening new horizons for functional assessment of myocardial ischemia in clinical practice.

Based on Mandi Medical’s long-standing clinical collaborations and research foundation, the Chinese Expert Collaborative Group on Cardiac Magnetism Technology was officially established at the 16th Oriental Congress of Cardiology (OCC 2022). The expert group comprises Zhongshan Hospital, Fudan UniversityAcademician Ge Junbo, Shanghai Institute of Microsystem and Information Technology, Chinese Academy of SciencesDirector Xie XiaomingServe as Team Leader, Professor Chen Yundai of the Chinese PLA General Hospital, Professor Lin Yixian of the Hong Kong Asia Heart Center, Professor Luo Jianfang of Guangdong Provincial People's Hospital, Professor Qian Juying of Zhongshan Hospital Affiliated to Fudan University, Professor Shen Chengxing of Shanghai Sixth People's Hospital, Professor Xu Yawei of Shanghai Tenth People's Hospital, and Professor Yu Bo of the Second Affiliated Hospital of Harbin Medical University served as deputy group leaders(The above list is sorted by pinyin.)，More than 70 leading experts in clinical practice and medical engineering from across China have joined the initiative. They will foster closer collaboration in areas such as clinical research, application standards, widespread adoption, and technological iteration, thereby advancing the development of magnetocardiography (MCG) technology and its applications.

Mandi Medical’s ability to become the first manufacturer of magnetocardiography systems to obtain an NMPA registration certificate in 2019 was inseparable from its core team behind the scenes.

General Manager Zhang Shulin,Ph.D. and Research Professor at the Shanghai Institute of Microsystem and Information Technology, Chinese Academy of Sciences, he has been deeply engaged in research and exploration in the field of biomagnetism since his doctoral studies. To date, he has accumulated 16 years of experience in the development and application of biomagnetic systems and has filed for or been granted more than 40 invention patents. He possesses unique insights and systematic experience in technological R&D innovation as well as corporate management and development.

Executive Deputy General Manager Zhao Zhenhua,Graduated from Shanghai Jiao Tong University with an MBA from the Antai College of Economics and Management. Has overseen the commercialization of numerous high-tech achievements and possesses extensive management and marketing experience in the medical device sector.

Deputy General Manager Bao Hao,Graduated from China Pharmaceutical University and holds an EMBA from Antai College of Economics and Management. Serves as the full-time Secretary of the Chinese Expert Collaboration Group on Cardiac Magnetic Technology and is a member of the China Cardiovascular Physicians Innovation Club (CCI). With over ten years of experience at GE Healthcare, possesses extensive expertise in brand development and marketing strategy.

Leveraging the robust technological and talent resources of the Shanghai Institute of Microsystem and Information Technology, Chinese Academy of Sciences (CAS), Mandi Medical boasts a team of distinguished experts in the field of biomagnetism and industry-leading technologies. By engaging with international experts in biomagnetism, the company has achieved numerous innovative breakthroughs.

Thirteen years of in-depth exploration have not only enabled Mandi Medical to master the core underlying technologies of biomagnetism, but also revealed a broader future for the company.

According to Researcher Zhang Shulin, Mandi Medical has established a clear“Point-to-Area Expansion, Innovation-Driven Vitality”of play.

First, adopt a point-to-area strategy to lay out the entire biomagnetism field.Starting with magnetocardiography (MCG) systems, Mandi Medical’s grand vision is to establish a comprehensive presence across the entire biomagnetism sector. Through continuous technological iteration and ongoing clinical advancement, the company aims to achieve large-scale market penetration and widespread application of biomagnetic technologies. Currently, Mandi Medical has embarked on a comprehensive strategic layout encompassing magnetic imaging, magnetic detection, and magnetic therapy, striving to become an international leader in magnetic biomedicine.

Secondly, maintain innovation vitality and continuously develop products that meet more clinical needs.Innovation is not only vital for corporate survival but also the primary driving force behind business growth. Innovation in medical devices stems from genuine and unmet clinical needs. In addition to iteratively optimizing its approved magnetocardiography (MCG) systems, Mandi Medical will extend biomagnetic technology to a broader range of clinical scenarios. Meanwhile, Mandi Medical is also conductingR&D and Strategic Reserve of New Technologies.

In terms of financing, Mandi Medical's previous round of funding occurred in September 2021, led byGuoke Development, CAS Capital, Shanghai Institute of Microsystem and Information Technology (Chinese Academy of Sciences), Shanghai Xinwei Technology GroupandShanghai Guoxinet al. jointly completedSeries A Financing Exceeding 100 Million YuanFinancing.

Existing Shareholder: Lianxin Capital“The evaluation stated: ‘Biomagnetic diagnostic technology is a cutting-edge field we hold in high regard, with broad application prospects for the diagnosis of cardiac and neurological diseases in the future. Mandi Medical boasts an outstanding R&D team and has accumulated over ten years of technical expertise in this domain. All key core components have been independently developed, and the company has taken the lead in obtaining registration certification for domestically produced magnetocardiography (MCG) equipment. It plans to expand into fetal magnetocardiography, magnetoencephalography (MEG), and neuromagnetic imaging, aiming to become a globally competitive leader in biomagnetic technology.’”

Currently, the company isStrategizing for a New Round of Financing and Development, promote the clinical application and widespread adoption of magnetocardiography technology, accelerate the research and development of equipment for fetal magnetocardiography, magnetoencephalography, and other biomagnetic technologies, vigorously develop the biomagnetism industry, and emerge as a leader in this field.

References:

1. [Frontier Technology | Professor Shen Chengxing’s Team: Mandi Magnetocardiography System—Opening New Horizons in “Coronary Microcirculation”]

2. The Chinese Expert Collaborative Group on Cardiac Magnetometry Was Officially Established at OCC 2022