Tingsheng Tech Files for IPO with Dual R&D Centers in China and the U.S., Targeting Import Substitution of 'Cardiac GPS'

The number of patients with atrial fibrillation in China has exceeded10 million people, with up to 525,000 stroke patients annually.Catheter Ablation is Included in the National Health Commission’s “Clinical Pathway for Atrial Tachycardia”(2010 Edition) as one of the clinical treatment protocols, but the national volume of such ablation procedures in China was only around 230,000 in 2018.

“When I was practicing as a physician, my daily work involved not only diagnosing and treating arrhythmias, but also persuading patients to undergo surgery. Nearly ten patients per day were indicated for ablation procedures, yet only two or three ultimately accepted the treatment. Most of them declined due to unaffordable costs,” stated Zhao Dongsheng, Chief Product Officer at TINGSN Technology and Attending Physician in the Department of Cardiology at Nantong First People’s Hospital.

For a long time, Zhao Dongsheng had hoped for a product that could reduce surgical costs, making surgeries more affordable for a broader population. In late 2018, he encountered his high school classmate, Zhang Dongyu, at the hospital. Zhang was hospitalized due to his father’s mild coronary heart disease. Through their conversation, Zhang gained insight into the current state of cardiac treatment procedures in China, where the high cost of imported consumables for interventional cardiology devices rendered such treatments unaffordable for most patients.

Zhang Dongyu told VCBeat, “Take my hometown of Nantong, a third-tier city, for example. The cost of an imported atrial fibrillation procedure is around RMB 70,000–80,000. Even after medical insurance reimbursement, many rural patients struggle to afford the treatment and may voluntarily forgo it.”

In light of this situation, they decided to develop domestically produced cardiac interventional therapy products to reduce costs and make them more affordable for patients.

In addition to the cost, very few doctors in primary-level hospitals across China are proficient in 3D radiofrequency ablation technology. However, the treatment of complex arrhythmias, most commonly atrial fibrillation, necessitates the use of 3D ablation therapy.

Producing import-substitute products to reduce costs, and ideally simplifying operations to enable the wider adoption of ablation procedures at primary healthcare levels. With this vision, Zhang Dongyu founded TINGSN. Currently, TINGSN’s main product portfolio consists of three offerings: first, a 3D cardiac mapping system; second, a mobile app for electrophysiologists’ training; and third, a PC-based surgical simulator.

TINGSN’s core product, the 3D cardiac mapping system, combines gyroscope chip-based positioning with ultrasound localization principles. It achieves real-time spatial positioning of interventional catheters by acquiring intracardiac coordinate information through catheter detection and localization. Using proprietary tagging and imaging algorithm software, the system identifies and reconstructs coordinate points where the catheter maintains optimal contact with the endocardial wall, thereby generating a three-dimensional image of the heart’s interior.

To understand the applications of 3D cardiac mapping systems, one cannot bypass radiofrequency ablation for the treatment of arrhythmias.

Arrhythmias constitute a significant group of cardiovascular diseases. They can occur in isolation or in conjunction with other cardiovascular conditions. Atrial fibrillation is the most common persistent arrhythmia, with an incidence rate reaching 10% among individuals aged 75 years and older. While patients with mild arrhythmias can maintain a normal lifestyle, severe arrhythmias involve complex clinical presentations that not only impair patients' daily living and work capabilities but also pose substantial health risks.

Treatment of arrhythmias includes pharmacological therapy and catheter ablation. For ablation procedures, there are currently two modalities: radiofrequency ablation and cryoballoon ablation.

Radiofrequency Ablation is an interventional technique in which an electrode catheter is introduced into specific sites within the cardiac chambers to deliver radiofrequency current, inducing coagulative necrosis of the local endocardium and subendocardial myocardium, thereby blocking abnormal conduction pathways and foci responsible for tachyarrhythmias.

Cryoablation utilizes heat absorption during the evaporation of a liquid refrigerant within a balloon to rapidly lower the temperature around the ablation target, thereby causing damage or death to tissue cells in that region through hypothermia.

These two procedures are indicated for different clinical conditions, with radiofrequency ablation having a longer history of clinical use. Overall, radiofrequency ablation does not require balloon assistance, can be advanced beyond the cardiac anatomical structures, and is supported by a precise three-dimensional mapping system, resulting in shorter fluoroscopy exposure time; however, it demands a higher level of catheter manipulation skill from the operator.

Cardiac 3D mapping serves as the “GPS” prior to cardiac radiofrequency ablation surgery. By performing cardiac 3D mapping, a three-dimensional model of the cardiac chambers can be constructed—simply put, a 3D map of the heart is generated to assist physicians in better executing the radiofrequency ablation procedure.

Three-dimensional cardiac mapping systems are also important adjunctive tools for reducing procedural complexity. Furthermore, compared to traditional fluoroscopy using X-rays and contrast agents, 3D mapping systems spare both physicians and patients from radiation exposure, thereby enhancing procedural safety and reducing the incidence of complications.

How large is this market? According to data from Professor Zhang Shuguo’s report at the annual conference of Fuwai Hospital, the national volume of ablation procedures in China exceeded 230,000 cases in 2018, with 140,000 of these being three-dimensional (3D) ablation procedures. The expenditure on surgical consumables surpassed RMB 10 billion. The annual growth rate for ablation procedures is projected to reach approximately 30%.

Three-dimensional cardiac mapping, an essential component of cardiac radiofrequency ablation procedures, is being developed and manufactured by numerous companies both domestically and internationally. Prominent examples include Johnson & Johnson, Abbott St. Jude Medical, and Shanghai MicroPort Medical. The technological principles employed by these manufacturers are predominantly based on magnetic field and electric field imaging technologies. In this market, key competitive factors include the accuracy of collected data points, imaging speed, and operability.

Unlike existing technical principles, TINGSN’s cardiac 3D mapping system employs ultrasound/radiofrequency technology. Zhang Dongyu stated, “Radiofrequency-ultrasound technology integrates modeling and localization capabilities, with product costs significantly lower than those of magnetic- or electric-field-based systems. The localization accuracy can reach within 0.5 mm. TINGSN’s cardiac 3D mapping system also enables real-time catheter localization for non-contact modeling, eliminating the need for point-by-point scanning by physicians and allowing for immediate imaging. It is also applicable to conditions involving complex anatomical structures where contact-based modeling catheters are ineffective.”

In addition to its 3D cardiac mapping system, TINGSN offers two other products. The first is China’s first free learning app for cardiac electrophysiologists, featuring catheter manipulation simulations based on 3D heart models, instructional content on cardiac electrophysiology and anatomy, and a professional community for physician interaction. The second is a PC-based surgical simulator that accelerates physicians’ proficiency through realistic haptic feedback.

Zhang Dongyu pointed out: “In China, hospitals equipped with 3D cardiac mapping systems are mostly tertiary hospitals in first- and second-tier cities. Nationwide, there are approximately 20,000 to 30,000 specialized cardiac electrophysiologists, yet only around 600 physicians across the country are proficient in performing these 3D-guided procedures. Furthermore, existing surgical simulators from foreign companies are costly and sold exclusively as bundles with their respective products, rather than being available for separate purchase, resulting in limited training opportunities for physicians.”

The ability to design products from a physician’s perspective is ingrained in the DNA of the TINGSN team. In an interview, Zhang Dongyu stated that assembling the TINGSN team was no easy feat. The five co-founders of TINGSN were all high school classmates. Although Zhang Dongyu and Dr. Zhao Dongsheng hit it off immediately, it took him a full month to persuade Han Yiyong, the Chief Technology Officer, to join TINGSN.

Yiyong Han has nearly eight years of experience specializing in biomedical imaging. He earned his Ph.D. in Electronics and Computer Engineering from the Technical University of Munich in Germany, completed his postdoctoral research in Electrical Engineering at Purdue University in the United States, and studied under the renowned international expert in biomedical engineering, Professor Vasilis Ntziachristos.

Although Han Yiyong was initially optimistic about Zhang Dongyu as a business partner, he was more inclined to pursue another entrepreneurial venture of his own. To persuade Han, Zhang Dongyu appealed to both his emotions and reason. Zhang stated, “Ultimately, I convinced him on two main grounds: first, our shared values—the 3D cardiac mapping system addresses a significant clinical gap, which is beneficial to patients; second, TINGSN already had relatively mature concepts and a solid foundation in product R&D.”

In addition, TINGSN has collaborated with Nanjing University, inviting Professor Zhang Dong, Deputy Dean of the School of Physics at Nanjing University, to serve as its Chief Technical Expert. Dr. Liu, an ultrasound modeling engineer at TINGSN, and Dr. Shen, an imaging algorithm engineer, both graduated from the Department of Acoustic Science and Engineering at Nanjing University. TINGSN has also partnered with the China Cardiovascular Innovation Alliance (CCI). The mentor team led by Academician Ge Junbo of the Chinese Academy of Sciences serves as the advisory team for TINGSN’s Innovation Pioneer Project, facilitating the commercialization and implementation of its 3D cardiac mapping system.

It was not long from the time Zhang Dongyu learned about the shortage of medical resources and equipment in cardiac interventional therapy to the establishment of TINGSN. However, Zhang Dongyu stated that TINGSN needs to accelerate its pace further. On the premise of ensuring technological leadership and competitive advantages, the company must strive to speed up product development to succeed in the track of import substitution and bring its products to clinical application more quickly.