Saihe Medical Files IPO Prospectus: Pioneering China's First Domestic Intravascular Lithotripsy System for Coronary and Peripheral Arterial Calcification

Vascular calcification has always been a difficult clinical problem, especially for deep calcified lesions, which lack effective treatment methods.

Shockwave Lithotripsy, as an emerging technology, combines traditional electrohydraulic lithotripsy and balloon angioplasty to efficiently and safely pre-treat moderate to severe calcified lesions in coronary or peripheral arteries. In recent years, some companies in the field of vascular intervention have begun to focus on the development of shockwave lithotripsy systems.

The foreign enterprise Shockwave Medical has seen its market value increase more than 10 times thanks to its core product, the shockwave lithotripsy system. Looking at the shockwave lithotripsy field in China, one company that cannot be ignored is SONOSEMI.

Against the backdrop where imported products almost monopolize the active therapeutic devices used in catheterization laboratories of cardiology departments in hospitals across China, founder Liu Bin established SONOSEMI in 2020. The aim was to introduce domestically produced devices into the market and break the monopoly held by imported products.

Established for less than two years,SONOSEMI independently developed China's first coronary artery shockwave lithotripsy system and has taken the lead in beginning clinical enrollment. Meanwhile, the peripheral artery shockwave lithotripsy system also completed its first clinical enrollment earlier this year.Moreover,The company has completed the development of a cavity imaging system based on ultrasound technology, and the system is expected to enter the clinical stage in the second half of this year.

SONOSEMI is a medical device company with the mission of "empowering healthcare with intelligent technology to serve human health" and the strategic goal of "becoming a global leader in the design and manufacture of active cardiovascular implantable and interventional medical devices."

Since its establishment in 2020, the company has grown from a "team" consisting solely of founder Liu Bin to a professional team that includes marketing experts and engineering technology specialists in the field of泛血管介入器械. Today, SONOSEMI has assembled a research and development team with extensive experience in biomaterials, electronic engineering, and other fields, recruited from well-known medical device and ICT (information and communication technology) enterprises.

Over 75% of the employees at SONOSEMI are R&D personnel.Product development is efficient and precise. At the same time, the company starts from clinical needs and collaborates with clinical expert teams from multiple well-known medical institutions in China to conduct clinical trials of the lithotripsy system. Moreover, the company has abundant supply chain resources and has established an extensive sales network in the peripheral vascular intervention market.

At this stage, SONOSEMI focuses on product development for two critical clinical scenarios: vascular calcification lesions and structural heart disease. The company’s primary focus is on the shock wave lithotripsy system to treat vascular calcification lesions.

Vascular calcification has always been a difficult problem in clinical treatment, and its incidence rate is increasing year by year.

The incidence of coronary artery calcification increases with age, with an incidence rate of approximately 80% in the population aged 60-69.Moderate to severe coronary artery calcification accounts for approximately 20-30% of the total PCI (percutaneous coronary intervention) procedures. Based on an estimated 1 million PCI procedures performed annually in China, there are approximately 200,000 to 300,000 patients with moderate to severe coronary artery calcification in China.

The incidence of peripheral arterial calcification is also related to age. According to statistics, the global incidence of PAD (peripheral arterial disease) is approximately 12%, and the incidence in people aged 60-69 and over 70 years old increases to 6.8% and 9.2%, respectively.Among more than 50 million PAD patients in China, over 50% are expected to exhibit peripheral vascular calcification.In 2020, the number of peripheral arterial interventional surgeries in China reached nearly 150,000.

For vascular calcification lesions, the commonly used treatment methods in clinical practice currently include non-compliant balloons, cutting balloons, plaque旋磨术, and excimer lasers. However, these treatment methods are only suitable for mild to moderate calcification lesions and are difficult to address deep calcification lesions.

In contrast, the intravascular lithotripsy system can efficiently and safely fracture calcified plaques without damaging the vascular endothelium. It achieves good therapeutic effects on calcified nodules, eccentric calcification, and both superficial and deep calcified lesions, making it suitable for the pretreatment of moderate to severe calcified lesions in coronary or peripheral arteries. Additionally, intravascular lithotripsy aligns with clinicians' operational habits, has a shorter learning curve, and is conducive to promotion in grassroots hospitals.

SONOSEMI's Self-Developed Coronary Shockwave Lithotripsy System Includes Two Parts: Shockwave Coronary Balloon Catheter and Intra-body Shockwave Therapy Device (Including Main Unit and Operation Handle). The system uses lithium battery DC power supply, with concentrated and efficient electrical pulse energy output. It features a simple human-machine interface and is easy to operate. The single shockwave balloon catheter has a long service life, and the balloon specifications are complete, offering a wide range of applications.

On October 19, 2021, the system completed its first clinical enrollment, and it is expected to complete the enrollment of all cases in the second half of this year.

Beyond coronary arteries, SONOSEMI's shockwave lithotripsy system has also expanded into peripheral arteries and aortic valve areas, with the independent development of a peripheral artery shockwave lithotripsy system. Calcified lesions in peripheral arteries are more complex, with a degree of calcification and length of calcified lesions far exceeding those in coronary vessels. Therefore, this system not only enhances the shockwave energy but also makes appropriate adjustments to the length and diameter of the balloon.

On April 17, 2022, SONOSEMI's peripheral arterial shockwave lithotripsy system completed the first clinical trial enrollment in China. Postoperative angiography of the first enrolled patient showed good lumen gain, no flow-limiting dissection occurred, no stent implantation was required, and the distal outflow tract was unobstructed.

Professor Dai Xiangchen from the Vascular Surgery Department of Tianjin Medical University General Hospital, who participated in this clinical trial, stated: "The success of the first case enrollment demonstrates the excellent performance of SONOSEMI's shockwave peripheral balloon in addressing severe calcified lesions. The high number of discharges allows clinicians to treat long-segment and multi-segment severe calcified lesions with greater ease. It can not only serve as a vascular preparation device to 'fracture' calcified plaques but also function as the final treatment tool, offering a new therapeutic strategy for the clinical treatment of peripheral vascular calcified stenosis."

Focusing on the clinical needs of structural heart disease, SONOSEMI initiated the development of intracardiac echocardiography (ICE) catheters from the outset of its establishment, applying them in atrial fibrillation radiofrequency ablation and interventional procedures for structural heart disease.

In traditional atrial fibrillation radiofrequency ablation surgery, X-rays are a necessary condition for achieving surgical visualization. In recent years, clinical practice has started to perform radiofrequency ablation under the guidance of intracardiac echocardiography (ICE), aiming for greater precision and safety.

Intracardiac Ultrasound: A Procedure Guiding Heart Surgery with Precision

During the surgery, doctors can observe the patient's heart condition in real time, promptly identify potential surgical complications such as thrombosis, pericardial effusion, and injury or edema at the ablation site, effectively reducing the occurrence of adverse events and improving surgical safety.

Radiofrequency ablation under cardiac ultrasound can significantly reduce X-ray exposure time, mitigating radiation harm to both patients and doctors. This is especially beneficial for patients with chronic renal insufficiency or contrast agent allergies. Beyond atrial fibrillation radiofrequency ablation, SONOSEMI is paying more attention to the application opportunities of intracardiac ultrasound in interventional procedures for structural heart disease.

Compared with traditional transesophageal echocardiography (TEE), the intracardiac ultrasound imaging catheter not only has the above advantages but also features flexible intraoperative operation, allowing doctors to adjust its spatial position and imaging angle. It can comprehensively measure target tissues and reduce operation time. Meanwhile, the intracardiac ultrasound imaging catheter is equipped with color Doppler ultrasound functionality, enabling blood flow and heart rate detection, which facilitates doctors in evaluating postoperative treatment effects.

But the research and development barriers for intracardiac ultrasound imaging catheters are high, and there are currently no mature domestically produced intracardiac ultrasound (ICE) products available in China. Core technologies related to intracardiac ultrasound imaging have long been monopolized by foreign manufacturers, becoming a key industrial短板 that restricts the localization process of China's high-end medical ultrasound imaging equipment.

SONOSEMI continues to invest resources in this technology field, breaking through technical barriers.

The first-generation intracardiac echocardiography catheter product launched by the company is a single-use 2D intracardiac echocardiography catheter, suitable for interventional treatment surgeries of structural heart diseases such as atrial fibrillation ablation, PFO closure, and left atrial appendage closure.Currently, the product is in the finalization and animal testing phase, with plans to initiate pre-market clinical trials in the second half of this year. Meanwhile, SONOSEMI is also developing its second-generation 3D intracardiac echocardiography imaging catheter.

In addition to breakthrough technologies and original products, the strategic goal of becoming "a global leading designer and manufacturer of active cardiovascular implantable and interventional medical devices" cannot be achieved without the long-term accumulation of SONOSEMI.

Liu Bin, the founder of the company, is a serial entrepreneur. Before founding SONOSEMI, he had nearly two decades of experience in the communications and semiconductor chip industries. His transition into the medical field was primarily driven by his personal values. He hopes that his professional development over the next twenty years will balance social responsibility with commercial value. The outbreak of the COVID-19 pandemic in early 2020 further accelerated his entry into the healthcare sector.

Liu Bin chose the cardiovascular industry as the entry point mainly because he saw that the localization rate of active diagnostic and therapeutic devices in the cardiac catheterization lab was basically zero, with a strong demand for domestic alternatives. Based on his past professional experience, he introduced some cutting-edge technologies from the communications and semiconductor chip industries into the medical device industry.

As a serial entrepreneur, Liu Bin has ventured into the medical device field and shared some of his insights: "On one hand, the business model design in the medical device industry presents more challenges compared to other industries, including elements such as corporate positioning, profit models, and the establishment of business systems. On the other hand, there are certain differences in product definition and development. Taking cardiovascular implant and interventional medical devices as an example, these products place greater emphasis on safety and clinical benefits, and their research, validation, and manufacturing processes are subject to stricter regulatory oversight."

Starting a business in the medical field, especially in the highly challenging cardiovascular implantation and intervention market, is not easy. However, SONOSEMI continues to do what is difficult but right to this day.

Next,In the field of泛 cardiovascular diseases, SONOSEMI will continue to focus on the design, development, manufacturing, and industry promotion of active vascular implantable medical devices, maintaining technological innovation in medical sensor chips. It aims to promote the widespread application of active implantable medical device products based on new medical sensors in the healthcare sector, continuously creating value for doctors and patients.