Saihe Medical's Intracardiac Echocardiography (ICE) System Gains NMPA Approval via Innovation Fast Track, Marking Rise of Domestic ICE Industry

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On July 18, 2024, the National Medical Products Administration (NMPA) approved the registration applications for two innovative products from Sonosemi Medical Co., Ltd.: the "Portable Ultrasound Diagnostic System" and the "Single-Use Intracardiac Echocardiography Imaging Catheter." This marksThe first domestically produced ICE system in China (catheter + main unit) to be approved after entering the innovative green channel.

SONOSEMI's self-innovated ICE system made in China has received high praise from clinical experts in the DISTINCT clinical trial. Experts indicated that the overall performance, including catheter maneuverability and image quality, has reached and partially surpassed the level of similar imported products from overseas. It is not only suitable for all routine cardiac interventional surgeries but also optimizes the operation of left atrial appendage closure under intracardiac echocardiography guidance, improving surgical efficiency and reducing complications.

Sonosemi Medical Co., Ltd. was founded in 2020.The product development team comes from well-known medical device and ICT enterprises. The companyAfter four years of development, SONOSEMI has broken through the technical barriers of high-end overseas medical devices and independently developed innovative active interventional products for pan-vascular applications, including a coronary intravascular shock wave therapy system, peripheral arterial intravascular shock wave therapy system, intracardiac ultrasound imaging system, and intravascular ultrasound.SONOSEMI will form a product matrix consisting of multiple products within 2024, providing customers with comprehensive, all-around solutions.

From the perspective of SONOSEMI's main clinical-end products and products under development, all of them are active vascular interventional devices. The entry barrier for such products is relatively high, and the likelihood of being included in centralized procurement in the short term is relatively low, which aligns with the current major trend in the development of China’s vascular intervention field.

Mr. Liu Bin, Chairman of SONOSEMI, stated: "We are very pleased to see the official approval of SONOSEMI's intracardiac echocardiography (ICE) imaging system. As the first domestically produced ICE system in China to enter the innovation fast-track pathway, we believe that the system's excellent performance will better meet clinical needs in the future and provide support for a wide range of clinicians and patients across various procedures. SONOSEMI will remain true to its original mission and continue to focus on technological innovation in cardiovascular interventional devices, empowering clinical diagnosis and treatment scenarios."

▲SONOSEMI 4D ICE Catheter

Ice Crystal Intelligence is one of the few manufacturers in China that has fully laid out 2D, HD, 3D, and 4D ICE product lines for cardiac interventions. To meet the usage requirements of different clinical scenarios, the company has developed the next-generation high-definition and high-speed intracardiac echocardiography (HD-ICE). The product adopts an industry-first new generation of acoustic energy conversion system, which can effectively improve signal acquisition, transmission efficiency, and image clarity. Meanwhile, the HD-ICE system uses China's first dedicated high-definition cardiac image processing system, employing the latest algorithm technology in the industry to achieve faster imaging speed, thereby meeting more clinical needs.

Ice Crystal Intelligence positions itself as an "interventional ultrasound imaging platform company," planning to use a cardiac interventional ultrasound platform as the entry point to comprehensively layout the interventional ultrasound imaging industry.From a horizontal perspective (track layout), Ice Crystal Intelligence's layout includes gastrointestinal interventional ultrasound, tracheal interventional ultrasound, urological/hysteroscopic interventional ultrasound, etc.

In the field of 4D ICE, Ice Crystal Intelligence has adopted the internationally mainstream electronic matrix transducer technology solution and correspondingly utilized a high-speed volumetric reconstruction algorithm. This solution offers a significant advantage in imaging speed compared to mechanical volumetric imaging solutions, allowing for more real-time observation of heart valve movements. It naturally excels in procedures with extremely high real-time requirements, such as mitral valve clipping. Relevant test samples have already been developed and are currently being prepared for further animal experiments.

It is reported that Ice Crystal Intelligence will soon initiate a new round of financing to accelerate the market promotion of its ICE-related products and the research and development of 4D-ICE products as well as other specialized interventional ultrasound products.

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