The 19th Frost & Sullivan Global Growth, Innovation and Leadership Summit, as well as the 4th New Investment Conference —— Life Sciences New Investment Summit Forum, hosted by Frost & Sullivan (Frost & Sullivan, abbreviated as Frost & Sullivan), a globally leading growth consulting company, was successfully held in Shanghai on August 28, 2025. The forum brought together more than 50 industry leaders, biopharmaceutical companies, medical device companies, investment institutions, and professional service providers. With the theme of 'Strengthening Foundations Internally and Steadily Riding the Waves', it focused on cutting-edge trends, innovative technologies, and globalization development strategies in the field of life sciences, aiming to promote industrial development and global cooperation.
At this forum, Wang Li, Chairman & CEO of Xinmai Medical, shared a keynote speech titled "Development Trends of the New Generation Cardiovascular Diagnostic and Therapeutic Devices".
Wang Li, Chairman & CEO of iHeartBeacon Medical
The following are the key points from Wang Li's speech:
I. Current status of diagnosis and treatment of cardiovascular diseases
Wang Li pointed out that cardiovascular diseases have become a major global public health challenge. Among them, the three major sub-sectors—heart failure, coronary artery disease, and heart valve disease—have a large patient base, with urgent clinical needs but significant shortcomings in diagnosis and treatment.
In the field of heart failure, there are over 64 million patients globally, with over 13 million in China. Approximately 3 million new cases occur each year, and the incidence rate increases significantly with age, reaching 3.2% in people over 75 years old. However, the prognosis for heart failure patients is poor, with an overall 5-year survival rate of only 35%, a terminal heart failure 5-year survival rate of 20%, and a 1-year survival rate of only 11% for patients with combined cardiogenic shock after drug treatment. At the same time, the readmission rate remains high, with a 30-day all-cause readmission rate of 25% and a one-year readmission rate of 69%. The core pain points in current diagnosis and treatment lie in the lack of early screening and monitoring management of 'pulmonary edema'. Existing clinical assessments, X-ray chest films, and pulmonary ultrasound methods have issues such as insufficient precision, long duration, or invasiveness, making it impossible to timely evaluate the state of pulmonary congestion and delaying the intervention opportunity for worsening heart failure.
In terms of coronary disease, China has 5.3 million inpatients and 1.8 million deaths each year. The average cost per inpatient is about 17,000 yuan, resulting in a health life year loss of 3.72 person-years per thousand people, indicating a broad treatment demand. In 2024, the number of PCI procedures in China was about 2 million. Drug-coated balloons (DCB), as an 'interventional non-invasive' innovative therapy, have been widely recommended by guidelines for use in scenarios such as ISR and small vessel disease. Moreover, after the centralized procurement, patient accessibility has improved. However, there is a gap between the Chinese and American markets. The first DCB in the United States was approved in 2024, with a medical insurance price of about $11,000 per device. Although China has achieved domestic substitution (with a domestic market share of over 75% in 2024), it still needs to break through high-end technology to meet global demand.
In the field of heart valve disease, the number of transcatheter aortic valve replacement (TAVR) surgeries has been growing rapidly. In 2024, the global number reached 246,500 cases, with China increasing from 8,200 cases in 2021 to 17,232 cases in 2024, with an annual compound growth rate of 28.1%. The annual number of surgical valve surgeries globally exceeds 325,000 cases, with about 92,000 cases in China. However, existing valves have obvious defects; biological valves have a lifespan of only 8-10 years and rely on manual manufacturing, mechanical valves require lifelong anticoagulation, and the treatment rate for mitral valve disease is extremely low (only 0.5%), resulting in a supply-demand gap of more than a hundred times. There is an urgent clinical need for innovative products to break through this situation.
II. Technological Breakthroughs in the New Generation of Cardiovascular Devices
Wang Li proposed that in response to the pain points in cardiovascular disease diagnosis and treatment, the new generation of devices has achieved key breakthroughs through technological innovation, covering three major areas: heart failure monitoring, coronary treatment, and heart valve replacement, thereby promoting the upgrade of diagnosis and treatment models.
In the field of heart failure monitoring, the Cardiomed ReDS pulmonary edema monitor fills the gap in 'pulmonary edema' monitoring. This product uses unique radiofrequency monitoring and imaging technology to achieve non-invasive, quantitative, and rapid monitoring through impedance technology. Patients do not need to undress and the reading time is less than 45 seconds, addressing the shortcomings of traditional methods. Clinical data show that ReDS-guided volume management in heart failure patients can significantly reduce the composite endpoint risk of 30-day mortality and readmission to the hospital by 91%. It is the only non-invasive and precise monitoring product for heart failure globally, differentiating it from invasive implantable devices such as Abbott CardioMEMS. At the same time, ReDS has built a rich product pipeline, with the ReDS Pro suitable for emergency departments, nephrology, and other scenarios, and the ReDS Home supports home use and connects to mobile apps. The continuous monitoring version is adapted for ICU intensive care and can also be extended to areas such as pneumonia, chronic kidney disease, and acute respiratory distress syndrome, achieving full-course management.
In the field of coronary disease treatment, the cardiac medical drug-eluting balloon SmartBird, developed by Xiamen Tiantan Medical Technology Co., Ltd., leads domestic products overseas with its technological advantages. It adopts the world's fourth-generation Paclitaxel + antioxidant coating, enhancing anticoagulant function. It has a better vascular drug transfer rate and a better long-term anti-restenosis effect. Moreover, it holds global patent authorization and is one of the few DCB products in China capable of entering European and American markets. The product has a reasonable structural design, excellent compliance, and can easily reach the site of stenosis lesions. In the future, its clinical indications are expected to expand to peripheral, dialysis, and neurovascular fields, further broadening its application scenarios.
In the field of heart valves, Medtronic has introduced revolutionary new materials for valves and mitral intervention products. The new material intervention aortic valve Sikelia®Achieve four major breakthroughs: The theoretical lifespan after implantation reaches 25 years, far exceeding the traditional biological valve's 8-10 years; the cost is only 1/5 to 1/10 of that of biological valves, improving efficiency and consistency through intelligent automated production; it does not rely on radial support force, reducing perioperative conduction block complications; it is 100% retrievable, providing a safety guarantee for surgeries and facilitating promotion in the underserved market. MitraFix transcatheter mitral valve replacement system®It is the only product globally that has achieved total ultrasound-guided mitral valve replacement, supporting three approaches: transapical, transatrial, and femoral vein. The delivery sheath is the smallest in size globally, and the Skin-to-Skin surgical time is only 20 minutes, with a short learning curve. Sixty-four cases of regulatory registration clinical trials have been completed, showing that its safety and effectiveness are superior to similar foreign products.
III. Industry Trends and the Layout of XinYi Medical
Wang Li believes that the core elements for the development of new-generation cardiovascular medical devices lie in global intellectual property, global innovative technologies, and global commercialization capabilities. In the future, the industry will develop towards non-invasive, minimally invasive, long-acting, and low-cost approaches. Chinese enterprises are expected to achieve global leadership through technological innovation.
HeartMed's competitive advantage is built around three core elements: In terms of intellectual property, we have a complete patent layout both domestically and internationally. For example, SmartBird holds global patent licenses, laying the foundation for globalization and commercialization; in terms of technological innovation, from ReDS's non-invasive monitoring technology to SmartBird's fourth-generation coating technology, and then to breakthroughs in the lifespan and recyclability of new material valves, we continuously introduce globally leading products; in terms of commercialization capabilities, our products have covered the Chinese market and are actively expanding into Europe, America, and countries along the 'Belt and Road'. For instance, SmartBird is promoting its overseas expansion, with new material valves and MitraFix.®Aim at global market gaps.
In the future, with the intensification of population aging and the rise in the incidence of cardiovascular diseases, demand for fields such as heart failure monitoring, coronary intervention, and heart valve replacement will continue to be released. Xinzhiliao Medical will continue to deeply cultivate technology research and development, improve its product pipeline, promote the globalization of cardiovascular devices in China, provide better and more accessible diagnosis and treatment plans for patients worldwide, and contribute to the improvement of cardiovascular disease diagnosis and treatment levels.
