TingSheng Medical Completes First Domestic ICE Exploratory Clinical Trial and Secures Nearly RMB 1 Billion Series A Financing

VCBeat learned第一时间 that TINGSN has recently successfully completed the first exploratory human clinical trial of China-produced ICE, and closed a nearly RMB100-million Series A round in December 2021, led by Yuanlai Capital, followed by TigerYeah Capital, KinghandCapital Management (Beijing) CO., Ltd., and Guangzhou Huangpu Biomedical Industry Investment Fund Management Co., Ltd. Existing shareholders Nuoyu capital and Taihe Capital Management Co., Ltd. continued to invest in this round. The proceeds will be used for the production of clinical trial samples of intracardiac echocardiography (ICE), new product development, team expansion, and company site expansion.

Previously, TINGSN completed its angel round of financing led by Taihe Capital Management Co., Ltd. in December 2020; and completed its Pre-A round of financing led by Nuoyu Capital with Taihe Capital Management Co., Ltd. as a follow-up investor in June 2021.

Director of the Cardiology Department at the First Affiliated Hospital of Nanjing Medical University, and Party Secretary and President Kong Xiangqing of Suzhou Hospital Affiliated to Nanjing Medical University, served as the Principal Investigator (PI) for this clinical trial. The team led by Director Sun Wei from the Cardiology Department of the First Affiliated Hospital of Nanjing Medical University used TINGSN’s product to complete the first clinical case of domestically produced ICE in China. The imaging of TINGSN’s ICE product was clear, its operation was safe, and the clinical data was positive.

Zhang Dongyu, CEO of TINGSN, stated: "The successful completion of the first exploratory clinical trial of domestically produced ICE and the rapid achievement of three rounds of financing within a year not only reflects the team's commitment to its entrepreneurial初心, the establishment of a forward-looking product strategy, and the strong execution and seamless collaboration that have expedited R&D progress while ensuring product quality, but also relies on the full trust of our shareholders and clinical directors, as well as their recognition of the speed and quality of our product development."

Since 2019, TINGSN has been assembling a team to develop intracardiac echocardiography (ICE) products. The core R&D personnel come from well-known medical companies such as Philips Healthcare, Mindray Medical, Lepu Medical, and TE Connectivity. They possess core technology R&D capabilities including hardware electronics, catheter technology, sensor manufacturing, and host algorithms. Within just two years, they completed the product design of ICE and began to gradually apply it in clinical settings.

Intracardiac Echocardiography (ICE) is a novel imaging technology that involves inserting an ultrasound probe through blood vessels into the heart chambers to emit and receive ultrasound signals. This avoids interference from tissues such as skin, thorax, and lungs, achieving real-time imaging. It is reported that intracardiac echocardiography ICE catheter imaging was applied as early as the beginning of this century to guide "transseptal puncture" and has gradually expanded its application range due to its excellent imaging performance.

Currently, intracardiac echocardiography (ICE) catheter imaging has been applied in various scenarios such as interventional treatment of complex arrhythmias, imaging of special anatomical structures that cannot be mapped by magnetic and electrical systems, imaging during structural heart disease interventions, radiofrequency ablation catheter-based treatments, and pacemaker lead implantations. Intracardiac echocardiography not only provides high-definition images of cardiac structures but also significantly reduces the treatment risks for patients.。

Taking atrial septal defect closure as an example, clinicians can obtain clear images of the atrial septum through ICE products, accurately measure the size of the atrial septal defect, and determine its positional relationship with structures such as the aorta, mitral valve, tricuspid valve, and superior and inferior vena cava. During the process of closing the atrial septal defect, ICE can guide the positioning and deployment of catheters and occluders with a clear field of view, improving the precision and safety of the procedure.

In other minimally invasive interventional procedures, ICE can also play a significant role. Johnson & Johnson China promotes ICE as a standard consumable for its Carto3 three-dimensional mapping system in clinical applications. Particularly in electrophysiology, ICE reduces the risk of surgical complications to zero through real-time intraoperative monitoring. It also guides physicians to perform surgeries more conveniently, shortening operation time, reducing radiation exposure, and improving the overall surgical experience for both doctors and patients.

With these advantages, ICE technology has become the ideal imaging modality for many procedures, such as atrial septal defect closure, catheter ablation of arrhythmias, and left atrial appendage closure.

The simultaneous boom in structural heart disease has made interventional valve surgery the future mainstream. However, this treatment requires extremely precise "eyes." The technological upgrade from TEE and traditional ICE to 4D electronic matrix ICE has made it highly possible for the clinical popularization of more complex interventional valve surgeries. At the 2021 Shanghai CIIE exhibition, Siemens and Johnson & Johnson respectively showcased their latest 4D electronic matrix intracardiac ultrasound catheters. In the future, 4D electronic matrix ICE will be widely used in interventional valve surgeries and radiofrequency treatments for complex arrhythmias.

In 2021, the clinical usage of ICE in China increased significantly. With the widespread clinical application of ICE in electrophysiology and structural heart disease surgeries, traditional ICE and the latest 4D electronic matrix ICE are expected to jointly form a precise niche blue ocean market exceeding tens of billions in scale over the next 5 to 10 years.

Currently, there are no mature domestically produced intracardiac echocardiography (ICE) products on the market, whether based on 2D or 4D electronic matrix technology. This market is still dominated by foreign brands. The relatively high cost of imported products imposes a significant burden on domestic patients' families and the national medical insurance system.

In 2019, TINGSN began close strategic cooperation with top domestic scientific research institutions, simultaneously establishing R&D teams in both China and the U.S., jointly completing the R&D and overcoming of core technologies for the ICE product. It is reported that this is the first domestically produced intracardiac echocardiography (ICE) product in China to independently master core technologies and possess independent intellectual property rights. Once this product is launched, it will break the overseas monopoly and provide Chinese patients with a more cost-effective, domestically produced ICE product.

Dr. Dongsheng Zhao, Chief Medical Officer of TINGSNStated: "Based on its own innovative R&D strength and the original intention of domestic substitution, with the support of well-known domestic and international clinical teams in cardiology, TINGSN's product development is closely integrated with clinical applications. Other cutting-edge clinical application technology products, including the 4D electronic matrix ICE under synchronous research, are committed to creating a closed loop for intracardiac electrophysiological surgery, establishing a strong technical barrier, and providing clinical doctors with a full life cycle solution for intracardiac electrophysiology."

Ms. Lei, Founding Partner of Yuanlai CapitalRepresentation: As an emerging technology in the international field of interventional cardiology, ICE boasts advantages such as safety, eco-friendliness, and real-time monitoring. In interventional cardiac treatments and electrophysiological examinations, it shows promising application prospects. The intracardiac echocardiography (ICE) developed by TINGSN is highly targeted and ranks among the leading level in China. It will break the pattern of overseas monopolies, filling the gap for domestically produced devices in this category, allowing more Chinese patients to benefit from advanced treatment options. TINGSN collaborates with top domestic institutions, and its platform’s rich functional strategies contribute to the company's sustained and stable development. Meanwhile, VCBeat Capital has great confidence in TINGSN’s strong resource integration capabilities, the team’s unity and progress, and their impressive execution ability. We firmly believe that TINGSN will have significant growth potential in the ICE and electrophysiology industries, continuously surpassing itself and introducing more breakthrough technologies.

Dr. Tianrong Ji, Founder of TigerYeah CapitalVisualization is a major trend in the medical field. Intracardiac echocardiography helps interventional physicians more intuitively see the structures inside the heart, providing real-time guidance throughout the ablation process and monitoring changes in the cardiac chambers, which improves the effectiveness and safety of ablation procedures. In China, intracardiac echocardiography is completely reliant on expensive imported products, limiting its application. TINGSN's products are expected to be the first to break foreign monopolies and achieve import substitution. TINGSN has established close cooperative relationships with top universities and hospitals in China, making its products technologically robust, clinically user-friendly, and highly expandable, with the potential to be applied in more clinical scenarios in the future. TigerYeah Capital is willing to work hand-in-hand with TINGSN to accelerate the product’s market entry for the benefit of a wide range of patients.

Chairman of Kinghand Capital, Zhang DafengIt shows that: The market for cardiac electrophysiology and structural heart disease in China is developing rapidly. Intracardiac echocardiography (ICE) technology is gradually maturing, and with its advantages of high imaging quality and strong real-time performance, it can more accurately locate anatomical structures, save operation time, reduce radiation exposure, and monitor complications in real time, making interventional treatment more precise, efficient, simple, and safe, but the technical requirements are extremely high. TINGSN, relying on the team's years of accumulation, has achieved a breakthrough in barriers and is expected to launch the first China-produced ICE product. We highly recognize the capabilities and execution of the TINGSN team and look forward to their achieving more technological breakthroughs and launching more cutting-edge products, bringing positive changes to cardiac electrophysiology and structural heart disease surgeries and saving more patients.

Senior Investment Vice President of Guangzhou Huangpu Biomedical Industry Investment Fund Management Co., Ltd., Yao LiangRepresentation: The aging population and the continuous advancement of medical technology have accelerated the development and penetration of cardiovascular interventional diagnosis and treatment technologies, which are inseparable from the development of ultrasound imaging technology. Intracardiac echocardiography (ICE) makes complex interventional treatments simpler for operators, with more precise anatomical positioning, shorter operation times, and less radiation exposure. While achieving excellent therapeutic effects, it significantly reduces treatment risks for patients. We are very optimistic about the application prospects of ICE in the field of structural heart disease intervention, such as left atrial appendage closure, heart valve replacement, and repair, bringing hope to more operators and patients. ICE products combine disciplines such as acoustics, materials science, electrical engineering, and image processing, presenting extremely high R&D barriers. As an innovative company, TINGSN is the first in China to independently develop intracardiac echocardiography (ICE) products, and we highly value its potential. We look forward to TINGSN breaking the import monopoly with its sophisticated technology and excellent products, and becoming a leading enterprise in China’s electrophysiology field at an early date.

Yang Zhiwen, Co-Founding Partner of Nuoyu CapitalExpressed: Confidence in the perseverance and execution of the TINGSN team. They have repeatedly dispelled investors' doubts with results: ICE imaging quality rivaling top international companies, independent R&D of ultrasound modules, 4D reconstruction algorithms… Every step has been challenging, but they are fulfilling their initial promises one by one. As long-term investors, we believe in the future of TINGSN and demonstrate our unwavering support for the team by continuing to increase our investment.

Dr. Chuxing Chu, Investor of Taihe Capital Management Co., Ltd.It shows that: the market demand for cardiovascular diseases is huge, and during interventional treatment, due to the continuous beating of the heart, the requirement for real-time cardiac imaging cannot be met by technical means such as CT and MRI. Although ultrasound imaging can meet this need, it has a relatively high technical threshold, which is also the main reason why this market has been dominated by foreign products. The high standards and efficiency of the TINGSN team have enabled their products to reach a leading level in China, with the potential to break the monopoly of imported products. This is the fundamental reason for our continuous three rounds of investment.

TINGSN, founded by senior scientists in the ultrasound field, cardiologists, and serial entrepreneurs, is headquartered in Nanjing, China. The company has built an international R&D team and established R&D centers in both China and the U.S. Focusing on technological innovation in the application of ultrasound for cardiac electrophysiology, TINGSN combines imaging, mapping, and ablation energy to provide more effective treatment for patients with heart diseases. The company aims to become a globally influential medical device brand manufactured in China.

Shanghai Yuanlai Investment Management Co., Ltd., headquartered in Shanghai, is a startup investment company dedicated to healthcare and core technology. The core members of the company’s team possess extensive experience in equity investment or deep industry backgrounds. Yuanlai Capital adheres to a diligent and prudent approach in conducting business, fulfilling its investment mission of bringing wealth appreciation to clients and creating value for enterprises. It emphasizes alignment with the company’s development philosophy and values, striving to assist companies in rapid growth and deliver substantial returns for investors.

TigerYeah Capital was established in 2014 as an independent venture capital institution under Tigermed. TigerYeah Capital focuses on equity investments in early and growth-stage healthcare sectors, with a management team that possesses deep industry background, extensive industry resources, and rich investment experience. To date, it has completed investments totaling 1.5 billion yuan across nearly a hundred projects, with an investment portfolio covering medical devices, biopharmaceuticals, CROs, and health foods. By empowering its invested companies, TigerYeah Capital creates value for the development of the healthcare industry in China and globally, contributing to public health.

Kinghand Capital Management (Beijing) Co., Ltd. is a leading equity investment institution focused on the healthcare sector, dedicated to leveraging capital and industry resources to help outstanding healthcare companies grow rapidly, providing better medical products and services to society, and enhancing human health. Kinghand Capital has invested over 2 billion yuan in funds across nearly 70 outstanding projects, of which more than 10 enterprises have completed IPOs, and nearly 10 companies are expected to complete IPOs within 1-2 years.

Guangzhou Huangpu Biomedical Industry Investment Fund Management Co., Ltd. is a professional private equity investment management institution. Its main sponsors are Guangzhou Development Zone Holding Group, Kinghand Capital, BeiGene, and Guoju Venture Capital. It focuses on investments in the life sciences and healthcare industry, with extensive investment layouts in biopharmaceuticals, IVD, and innovative medical devices. The fund under its management leverages BeiGene's biopharmaceutical R&D advantages, based in the Guangdong-Hong Kong-Macao Greater Bay Area, and taps into academic resources from across China and even globally. It is committed to incubating and empowering life science and innovative healthcare projects, working closely with outstanding entrepreneurs to create top-tier products that help humanity overcome diseases and promote health.

Nuoyu Capital is a professional investment institution focused on medical devices and digital healthcare. Based on the long-term accumulation in medicine and the healthcare industry, we adhere to understanding the healthcare industry from the perspective of medicine itself, cultivating the fertile ground of medical innovation, and seeking out and supporting entrepreneurs who truly understand the essence of medicine. Upholding the cooperative philosophy of trust, inclusiveness, support, and watchful waiting, we work together with entrepreneurs to forge the future.

Taihe Capital's healthcare investment team has adhered to the philosophy of "discovering value, creating value, and sharing value" over the past decade. Focusing on early-stage equity investments in companies with high technological barriers, efficient execution capabilities, and a strong entrepreneurial spirit, they have invested in multiple enterprises across fields such as IVD, cardiovascular, and orthopedic high-value consumables. They also support their portfolio companies in delivering high-quality products and services to society.