Recently, the National Medical Products Administration (NMPA) of China approved the registration application for the innovative product "Disposable Intracardiac Ultrasound Diagnostic Catheter" produced by Jiangsu TINGSN Technology Co., Ltd. The registration certificate number is "GuoXieZhuZhun 20233061761".

Source: Official website of the National Medical Products Administration of China

It is reported that TINGSN, established in 2019, focuses on the development of globally leading interventional surgical instruments for cardiac electrophysiology. After five years of nearly 300 million yuan in R&D investment, the company has achieved multiple "firsts" in its field.The TINGSN Sonic Eyes 10 product, which has been approved this time, is the first domestically developed and approved high-end intracardiac echocardiography diagnostic catheter in China.At the same time, the company is also the third team in the world to have the capability to develop 4D ICE self-research chips, and is currently accelerating the research and development of 4D ICE intracardiac ultrasound products, with a full system layout in the field of cardiac electrophysiology.

Intracardiac Echocardiography (ICE) involves mounting a miniature transducer on the tip of a catheter, which is then inserted into the heart chamber via the femoral vein. The transducer emits sound waves, and the returning echoes are processed by a computer to generate ultrasound images. These images provide high-resolution, real-time visualization of the internal anatomy of the heart chambers, as well as other catheters and devices within the heart, while also enabling real-time monitoring of hemodynamic status. Unlike traditional ultrasound techniques,Intracardiac ultrasound is characterized by high imaging quality, strong real-time performance, and nearly 360-degree observability, allowing for better assessment of cardiac function and pathological conditions.At the same time, doctors can more accurately identify diseased areas, determine the optimal surgical plan, and improve the success rate and outcomes of the surgery.

It should be noted that ICE products integrate multi-dimensional cutting-edge technologies such as material development, transducer design, catheter packaging, precision mechanical transmission, and imaging algorithms, presenting a high technical barrier and market concentration. Since its FDA approval in 1999, the intracardiac echocardiography (ICE) product has been widely used in clinical settings, but its core technology is monopolized by only a few foreign giants.In the Chinese market, the intracardiac ultrasound market has been completely monopolized by multinational medical device companies for a long time.

Facing a vast market, in order to break the long-term technical monopoly of foreign brands,Since 2019, TINGSN has invested nearly 300 million yuan in research and development funds, introducing dozens of returned overseas PhDs and top R&D talents in China.Build a complete R&D and production team for transducer development, chip design and processing, bonding process development, ultrasound imaging algorithm development, and ultrasound modeling and navigation algorithm development.From the probe, adjustable catheter to the mainframe system, a complete high-tech barrier closed-loop ecosystem has been established; through large-scale investment in high-end hardware equipment, high-precision semi-automated production control, and all core components are self-developed and self-produced,Achieve the advantage of low-cost and high-performance products to cope with the fierce market competition in China and the strategic arrangement for going overseas in the future.

Through years of dedicated research and development, along with continuous and substantial investment in R&D,TINGSN Technology has set multiple firsts in China for intracardiac ultrasound products and related technologies, continuously leading the industry's development.

• The First to Launch Exploratory Human Clinical Trials:In March 2022, the team led by Sun Wei, Director of the Cardiology Department at the First Affiliated Hospital of Nanjing Medical University, utilized TINGSN ICE from Jiangsu TINGSN Technology Co., Ltd. to complete the first clinical surgery in China using domestically produced intracardiac echocardiography (ICE) with independent intellectual property rights, marking a new breakthrough in the localization of ICE in China.

• The First to Enter the NMPA Innovative Medical Device Special Approval Channel:In January 2023, TINGSN's "Single-Use Intracardiac Ultrasound Catheter" officially entered the special review process for innovative medical devices by the National Medical Products Administration (NMPA).

• The First to Complete Registered Clinical Trials:In December 2022, TINGSN officially launched the multi-center clinical trial of its intracardiac echocardiography (ICE) catheter. Professor Kong Xiangqing, Director of the Cardiology Department at the First Affiliated Hospital of Nanjing Medical University and Chief Scientist of Suzhou Hospital Affiliated to Nanjing Medical University, served as the Principal Investigator (PI) for this registration clinical trial. In early March this year, the first patient was successfully enrolled in the trial. By early June, after completing hundreds of cases in the registration clinical trial, TINGSN’s intracardiac echocardiography (ICE) product entered the registration review stage.

• The First Domestic ICE Enterprise Approved for Intracardiac Echocardiography Products:Recently, TINGSN Sonic Eyes 10, an innovative product developed by TINGSN Technology, has officially received NMPA approval for marketing. It has become the first domestically developed and approved high-end intracardiac echocardiography diagnostic catheter product in China.

As the first high-end intracardiac echocardiography diagnostic catheter approved for marketing in China, TINGSN Sonic Eyes 10, developed by TINGSN, consists of a catheter body, an operating handle, and a connector. Used in conjunction with the company's portable color ultrasound diagnostic system, it is suitable for medical institutions to perform ultrasound imaging of the heart, major cardiac vessels, and intracardiac anatomical structures.

By performing 2D imaging and 3D modeling of the heart area using high-frequency ultrasound, TINGSN Sonic Eyes 10 can achieve ultrasound surgery accurately, quickly, and efficiently.Can provide real-time accurate anatomical images while monitoring hemodynamic changes, with good display of cardiac tissue characteristics and fine structures. It enables real-time monitoring, timely detection of surgery-related complications, and maximum assurance of surgical safety. The product's market launch is beneficial in reducing clinical treatment costs, allowing more patients to benefit.

China's First Self-Developed Intracardiac Ultrasound Products TINGSN Sonic Eyes 10 and TINGSN FINDERS 1

Principal Investigator (PI) of TINGSN’s ICE Registration Clinical Trial – Professor Xiangqing Kong (Director of Cardiology Department, First Affiliated Hospital of Nanjing Medical University, Jiangsu Provincial People's Hospital; Director of the Ministry of Education's Engineering Center for Intelligent Diagnosis and Treatment Technology and Devices; Director of the National Standardized Cardiovascular and Metabolic Diseases Center) once stated, "TINGSN Technology's domestically produced ICE product has been well clinically validated in the treatment of arrhythmias and occlusion procedures."Its control method and imaging effect are consistent with imported products, and in some scenarios, it performs even better than imported products."It can effectively guide the operator to complete the surgery more quickly, reducing the exposure of both the operator and the patient to X-rays during the procedure. We look forward to the early market launch of TINGSN's ICE product."

While successfully completing the approval of 2D intracardiac ultrasound, as one of the world's third team with the capability to develop a self-researched 4D ICE chip, TINGSN TechnologyAccelerating the R&D of 4D ICE Intracardiac Echocardiography Products. Compared with 2D ICE catheters, 4D ICE catheters can simultaneously provide high-quality two-dimensional and real-time three-dimensional images (4D images), including 3D volume and 4D color Doppler imaging, offering more intuitive and clearer guidance for interventional cardiac surgeries.Such as complex mitral valve repair and replacement surgeries and the treatment of tricuspid regurgitation (TriClip), etc., have broad application prospects in the development of complex structural heart disease and arrhythmia surgeries.

In recent years, in order to improve the localization level of medical devices in China, a series of policies and measures have been introduced intensively, shifting from "encouraging domestically produced products" to "prioritizing domestically produced products." With the introduction of support policies and the advancement of innovative technologies, the process of independent innovation in China's domestic medical device industry has accelerated, significantly increasing the localization rate of products.

Against this backdrop, TINGSN has established a production-research center in China that integrates industry, academia, research, and medicine. It has engaged in in-depth collaborations with leading domestic scientific research institutions, national medical centers, and well-known regional medical institutions to build a localized innovation ecosystem. TINGSN has successfully assembled an elite team of industry experts specializing in core technology development, including transducer R&D, chip design, material development, software system construction, imaging algorithms, and ultrasound modeling.

While accelerating the development of intracardiac ultrasound products, TINGSN's 3D ultrasound mapping system is also under simultaneous development.By means of ultrasound imaging and ultrasound positioning principles, the ultrasound positioning catheter is used to detect, locate, and confirm the coordinate information inside the heart, constructing a real-time 3D image of the heart chamber while acquiring corresponding electrical signal information, providing "GPS" navigation services within the heart chamber for subsequent ablation treatment.

TINGSN Technology Ultrasound Ablation System Concept Diagram

In the field of intracardiac electrophysiology surgical treatment, TINGSN has also developed an ultrasound ablation system.This system uses interventional focused ultrasound energy as an alternative to traditional radiofrequency ablation therapy. An electrode catheter equipped with an ultrasound transducer is inserted through the femoral vein into a targeted area within the heart chamber, where it releases ultrasound energy to cause necrosis of the internal endocardial tissue at the lesion site, thereby blocking abnormal conduction pathways and focal points.

In the future, TINGSN will continue to focus on enabling more patients with heart disease to receive more effective treatment, becoming a warm, ambitious, and internationally influential Chinese medical device brand.

END

 

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