Meio Medical: Pioneering Cardiac Navigation and Robotic Systems in the Billion-Dollar Electrophysiology Market

Radiofrequency Catheter AblationRadiofrequency catheter ablation is one of the therapeutic approaches for arrhythmia. Under the guidance of digital subtraction angiography (DSA), electrode catheters are introduced into the heart via vascular puncture. The procedure first involves mapping to identify the location of the abnormal substrate responsible for tachycardia. Subsequently, high-frequency electrical current is delivered locally at the target site, generating high temperatures within a confined area. This thermal energy causes evaporation of intracellular water, leading to tissue desiccation and coagulative necrosis, thereby achieving the therapeutic objective.

According to data from the 301 Hospital, China currently sees approximately 300,000 new cases of arrhythmia annually, with the total number of patients exceeding 70 million. Among these, 30% (approximately 20 million patients) require surgical intervention. However, as of 2016, only 120,000 cardiac interventional procedures were performed annually in China. The incidence of arrhythmia is rising steadily amid an aging population. The prevalence of non-valvular atrial fibrillation reaches as high as 9% among individuals aged 75 and older. Clinical disability rates due to stroke caused by various types of atrial fibrillation exceed 30%.

For complex arrhythmias, surgical intervention, device implantation, and minimally invasive catheter-based procedures are currently the primary treatment modalities, surpassing pharmacological therapy. Catheter radiofrequency ablation is technically demanding and carries a risk of complications, thereby imposing stringent requirements on operators’ expertise and technical equipment. This has, to some extent, hindered its widespread adoption. In response, Stereotaxis, based in St. Louis, United States, developed automated cardiac navigation technology, becoming the world’s sole manufacturer of magnetic navigation systems for arrhythmia localization, which has significantly improved procedural success rates.

Professor Lu Caiyi, Chief Physician and Director of the Department of Cardiology at the 301 Hospital, stated that only 10 StereoTaxis magnetic navigation systems have been introduced in China to date. In top-tier cardiac treatment centers across Europe, the United States, and China, catheter radiofrequency ablation has become a standard procedure for treating arrhythmias, with success rates reaching 80%–90%. In the future, low-cost, high-success-rate magnetic navigation-guided precise ablation will be the preferred therapeutic approach for the complete management of arrhythmias.

Given the market gap and demand, Meio Medical aims to become the leader in the field of robotic magnetic navigation catheter ablation systems. Benchmarking against Stereotaxis, Meio Medical is committed to creating novel cardiac automated navigation technologies and developing a cardiology magnetic navigation platform and magnetic catheter consumables system with independent intellectual property rights.

Chen Yuemeng, founder and CEO of Mayo Magnetic Navigation, told VCBeat that the artificial stereotactic navigation techniques widely used in clinical practice currently have two major drawbacks: first, they require fluoroscopic X-ray guidance for catheter manipulation, resulting in significant radiation exposure; second, surgical staff must wear lead-lined X-ray protective apparel during procedures, leading to high physical strain and posing risks of load-induced injuries to the spine and joints.

Mayo Heart Magnetism’s magnetic navigation stereotactic therapy technology reduces radiation exposure for patients and surgical teams, lowers the physical workload of surgical staff, extends their career longevity, and significantly shortens the learning curve for mastering procedural techniques.

Chen Yuemeng and the core R&D team of Mayo’s cardiac magnetism project chose to launch a venture in the field of interventional cardiology, driven by their optimism about the opportunities and potential of interdisciplinary medical-engineering collaboration, as well as the unmet needs in this sector.

Mayo Heart Magnetism was established in June 2018, co-founded by Dr. Chen Yuemeng and Professor Lu Caiyi, Director of the Department of Cardiology at the Chinese PLA General Hospital (301 Hospital). Its clinical research is conducted at the Chinese PLA General Hospital (301 Hospital), while its production and R&D base is located in the Shangyu Economic Development Zone, Shaoxing City, Zhejiang Province.

In 2014, Chen Yuemeng, who had spent over a decade developing chips and high-tech products in Silicon Valley, USA, chose to return to China to launch his own venture. He founded Hanlin Technology, a company dedicated to vital signs monitoring. With “health tracking” as its entry point, the project provides deep health-oriented wearable smart devices to capture human vital signs and activity data, delivering health data solutions for vertical industry sectors. Chen’s vision was to ultimately advance into the medical field of precise data-driven diagnosis through big data-based health prediction. A discussion with Professor Lu Caiyi, Chief Physician of the Department of Cardiology at the 301 Hospital (Chinese PLA General Hospital), prompted Chen to take further steps toward diagnostic applications. Their joint research on reducing the cost of cardiac surgeries and improving procedural safety paved the way for the emergence of Mayo Magnetocardiography.

“Bridging the gap from the health data sector to the fields of medical diagnostics and surgical robotics requires two key elements: team support and theoretical underpinnings,” Chen Yuemeng told VCBeat. Health and healthcare are distinct domains, with healthcare services presenting a significantly higher barrier to entry. In the health sector, possessing a large-scale database enables companies to analyze disease trends or the direction of industry data development. Healthcare services, however, demand precise diagnosis and treatment. This represents a transition from a domain focused on scale to one requiring extremely high precision, such as surgical interventions.

To successfully develop an automated cardiac navigation platform and a robotic interventional surgery system, Chen Yuemeng assembled Mayo Heart Magnetism by combining his own team with years of experience in industrial product R&D, a clinical team composed of authoritative cardiologists from the Department of Cardiology at PLA General Hospital (301 Hospital), and a core electromagnetic navigation R&D team with backgrounds from the Massachusetts Institute of Technology (MIT).

Leveraging over 30 years of clinical experience in interventional procedures from the Department of Cardiology at PLA General Hospital (301 Hospital), theoretical support from the Electromagnetic Research Laboratory of the Department of Information and Electronic Engineering at Zhejiang University, and years of accumulated expertise in digital signal processing for vital signs monitoring by Hanlin Technology, Mayo MagnetoCardio is dedicated to developing cutting-edge, integrated technologies for precise, minimally invasive diagnosis and treatment. The company aims to minimize the costs of cardiac interventional procedures while enhancing their safety and success rates, thereby making catheter ablation the safest cardiac interventional procedure.

According to the latest data from the National Center for Cardiovascular Diseases, cardiovascular disease has become the leading cause of death among residents in China. In terms of diagnosis and treatment plans for arrhythmia, 70% of patients can manage their condition with medication, while 30% require surgical intervention. Compared with pharmacological treatment, the adoption rate of surgical treatment remains relatively low.

It takes an average of 300 interventional procedures to train an experienced interventional cardiologist, resulting in a steep learning curve. High technical and equipment requirements, along with elevated medical costs, have increasingly become critical barriers limiting the widespread adoption of arrhythmia surgeries. This is the primary reason why Mayo Heart Magnetism is dedicated to developing robotic systems for cardiac interventional procedures.

Where there is pain, there is opportunity. Chen Yuemeng stated that as of 2017, approximately 20 million people required surgical treatment. Assuming an average cost of RMB 80,000 per procedure, the total market size would exceed RMB 1.6 trillion. Furthermore, with around 300,000 new cases of cardiac arrhythmia emerging annually in China, the incremental annual market value from surgical procedures amounts to approximately RMB 24 billion. “In the future, the market size for cardiac electrophysiology will reach the hundred-billion-yuan level.”

Rapid qualitative detection of lesions is a clinical challenge in catheter radiofrequency ablation, and Mayo Heart Magnetism is a company that specializes in tackling such difficult problems.

The “MEIO Magnetic Navigation” Stereotactic Positioning and Precision Ablation System is the flagship product of Mayo Heart Magnetism. It comprises four components: a magnetic navigation console, a 3D mapping and ablation system, flexible magnetic catheters, and a magnetic navigation workstation. Under fluoroscopic angiography guidance, the system generates variable magnetic fields centered on the heart to precisely position the flexible magnetic catheter within the cardiac chambers, thereby enabling accurate mapping and ablation of arrhythmogenic foci.

This system employs an advanced intelligent pressure-sensing saline-irrigated magnetic catheter that can intelligently detect cardiac wall pressure. It not only achieves superior ablation outcomes but also significantly reduces the consumable cost per procedure, bringing the risk of complications associated with manual ablation down to zero.

Computer-controlled integrated surgical system, featuring a main platform guided by an electromagnetic navigation field, offers high flexibility and miniaturization. It is compatible with existing catheterization laboratories and integrates seamlessly with current radiofrequency ablation devices. Chen Yuemeng disclosed to VCBeat that the system would gradually commence in vivo animal experiments by the end of 2019, with plans to obtain medical certification and achieve mass production and market launch by 2022.

Taking the 301 Hospital as an example, the procurement cost of imported equipment exceeds RMB 30 million. In comparison to imported products, the cost of Mayo’s cardiac magnetic navigation system has been significantly reduced. The competitive pricing of Mayo’s complete cardiac magnetic navigation system holds revolutionary potential for promoting radiofrequency ablation of arrhythmias, demonstrating substantial commercial viability.

In addition to this system, Mayo Heart Magnetism has filed multiple independent invention patents and developed a comprehensive smart catheterization laboratory solution based on a magnetic navigation platform, aiming to create a core cardiology business loop encompassing data analysis, intelligent diagnosis, and magnetically guided surgery. Chen Yuemeng stated that over the next five years, Mayo Heart Magnetism plans to integrate magnetic navigation into an all-in-one device and gradually promote its adoption in the catheterization laboratories of county-level public people’s hospitals.

VCBeat has learned that Mayo Heart Magnetism is currently undertaking a financing plan to accelerate the clinical trials of its “MEIO Magnetic Navigation” three-dimensional positioning and precise ablation system.