Xinrui Medical Secures Tens of Millions in Pre-A Funding to Accelerate Development of Polymer Heart Valves

VCBeat learned第一时间 that recently, Suzhou Xinrui Medical Technology Co., Ltd. (hereinafter referred to as "Xinrui Medical") announced the completion of a Pre-A round of financing worth tens of millions of yuan, led by HM CAPITAL with participation from Northern Light Venture Capital. The funds raised will mainly be used for the advancement of core products, talent recruitment, and the development of new products.

Xinrui Medical, established in December 2021, focuses on the research, development, and production of cardiovascular-related medical devices. Centering on polymer valves, Xinrui Medical is comprehensively expanding its product pipeline through independent research and development as well as industry-academia-clinical-research collaborations, supporting healthcare professionals in providing high-quality medical services to patients.

According to reports, Xinrui Medical adheres to innovation from the source. Its polymer valve, from material synthesis to configuration design, is independently developed. The core material of the valve has previously completed third-party testing, and the results show that the material's core performance is at a globally leading level. Meanwhile, Xinrui Medical's self-developed polymer valve surpasses traditional mainstream valve products in hemodynamic aspects (such as EOA, leakage performance, etc.) and fatigue resistance characteristics.

As of now, Xinrui Medical has multiple polymer valve products advancing in parallel.

Dr. Gong Bing, General Manager of Xinrui Medical, stated: "After the completion of this round of financing, the company will continue to adhere to innovation and product quality as the lifeline of the company, rapidly advance products into clinical use, continuously enrich the product pipeline based on market demand, strengthen the development of China's cardiovascular industry, and realize the social value of the enterprise."

It is worth mentioning that, Xinrui Medical, only about half a year after its establishment, secured an exclusive investment of over ten million yuan from Northern Light Venture Capital during a capital market downturn. With this round led by HM CAPITAL and Northern Light Venture Capital’s continued backing, Xinrui Medical has demonstrated exceptionally strong financing capabilities. Why is Xinrui Medical so highly recognized and favored by investment institutions? We will conduct a comprehensive analysis from aspects such as the market it operates in and the company's competitiveness.

Valvular heart disease is caused by factors such as inflammation, ischemic necrosis, degenerative changes, myxomatous degeneration, congenital malformations, rheumatic diseases, and trauma, leading to abnormalities in the heart valves and their associated structures. Based on the structure of the heart valves, the treatment market can be preliminarily divided into the aortic valve, mitral valve, and tricuspid valve.

"The Report on Cardiovascular Health and Diseases in China 2020" shows that the prevalence rate of valvular diseases in China is 3.8%, affecting approximately 25 million people, among which 1.5 million are patients with severe aortic stenosis. Meanwhile, with the increase in aging population trends, the incidence of valvular diseases rises year by year.

Based on the large population of patients and the harmfulness of the disease, the market space for valvular heart disease is expected to exceed 100 billion yuan.

In terms of treatment, replacing artificial heart valves is the most effective method for treating patients with severe valvular heart disease. Currently, artificial heart valves can be divided into mechanical valves (made of pyrolytic carbon) and biological valves (made from biological tissues sourced from pigs, cows, etc.) based on the materials used.

Mechanical ValveThe design service life exceeds 50 years, but the blood compatibility of pyrolytic carbon material is poor, which can easily lead to complications such as thromboembolism, and patients may experience postoperative...Must take anticoagulant drugs for life。

It should be noted that warfarin, the main anticoagulant drug currently available, has a narrow therapeutic window, significant inter-individual dose variability, and is easily influenced by diet and concomitant medications. Patients must constantly pay attention to their diet, medication, dosage, and timing of administration. Moreover, they are required to regularly undergo INR testing for personalized dosing to maintain optimal anticoagulation levels. This demands extreme self-discipline from patients, significantly reducing their quality of life.

Biological ValveThey are made from biological tissues sourced from pigs, cows, etc., and have good blood compatibility, requiring patients to take anticoagulants for only 3-6 months post-surgery. However, the service life of biological valves is only 10-20 years, which makes it difficult to meet the needs of increasingly younger patients with valvular diseases. Some patients even experience valve tissue calcification and valve failure shortly after valve replacement. Additionally, the price of biological valves is also higher compared to mechanical valves.

In developed countries in Europe and America, bioprosthetic valves have gradually replaced mechanical valves. However, in China, mechanical valves are still the most widely used. On one hand, China is still a developing country with an economic level lagging behind developed countries in Europe and America; on the other hand, valvular heart disease patients in China are mainly those with rheumatic heart valve disease and congenital heart valve disease, with an average age lower than that of valvular heart disease patients in Europe and America, making mechanical valves, which have a longer service life, more suitable.

Despite the fact that valve technology has been applied for over 50 years, the 10-year mortality rate of valve replacement remains as high as 30%-55%. Fortunately, with the breakthrough in polymer materials, artificial valves are ushering in a new transformation.

Xinrui Medical stated: "Polymer valves, based on breakthroughs in materials science, combine the dual advantages of mechanical and bioprosthetic valves and are considered the future of heart valves. Polymer valves not only have excellent fatigue resistance and a long service life but also possess exceptional blood compatibility, eliminating the need for patients to take anticoagulants long-term.”

The core barrier of the new generation of valves lies in the synthesis and design of leaflet materials. Ideal valve materials should possess excellent blood compatibility and superior durability, as well as features like anti-coagulation, anti-degradation, and anti-calcification.

As of now, only a few companies worldwide have mastered the core technology of polymer valve materials. Among them, the core members of Xinrui Medical have long been engaged in the research and development of polymer synthesis and polymer-related medical devices, possessing significant advantages in polymer medical materials.

At the same time, the Core Medical team maintains close ties with clinical practice. For instance, Core Medical's founder, Gong Bing, is a surgeon by training and later worked in cardiac surgery and materials research. Additionally, several members of the Core Medical team have previously held positions at well-known medical device companies, contributing to the development of multiple pioneering products in China. They possess comprehensive product development experience and mature industrialization thinking.

In addition to the team's strengths, Xinrui Medical has also built a research and production center of approximately 2,600 square meters within just one year, which can meet a series of needs for polymer materials from testing to synthesis.

Based on the software and hardware advantages of Xinrui Medical, it has laid out plans for polymer surgical aortic valves, mitral valves, and interventional aortic valves. It is expected to enter clinical trials by the end of this year or early next year.

It is worth mentioning that since the establishment of Xinrui Medical, it has rapidly completed over 50 iterations in just about one year. Throughout the process, Xinrui Medical continuously improved the design and synthesis of materials, verified and optimized product performance, and innovated from the most original and fundamental aspects by optimizing product designs based on input from doctors and patients, despite the lack of relevant resources in China.

Thanks to the original innovation of Cardiall Medical, the material of its polymer valve has been tested by a third party, and the results show that: the key performance is basically consistent with Foldax, a globally leading polymer valve company, and it fully meets the usage requirements for heart valves.

At the same time, HeartSharp Medical innovates in the leaflet structure, making it superior to traditional mainstream valve products in terms of effective orifice area, leakage performance, and other hemodynamic aspects.

From the core elements of polymeric valves, Xinrui Medical is at a globally leading level in aspects such as polymeric materials and leaflet structure design. Xinrui Medical stated: "In the future, the company will accelerate the advancement of several core products into clinical trials, evaluate the safety and efficacy of the products, and promote their rapid marketization to better serve patients and doctors."

General Manager of Xinrui MedicalDr. Gong Bing expressed: "We are very grateful for the investors' recognition of Xinrui Medical. Since its inception, Xinrui Medical has regarded product innovation, performance, and quality as the lifeline of the company's development. By addressing actual clinical pain points, the company continuously innovates based on existing technologies and products. Currently, the development of the company’s polymer valve is proceeding smoothly, and related products are rapidly advancing toward clinical application. The products’ excellent hemocompatibility and hemodynamic characteristics will better address the critical issues faced by patients with valvular disease."

HM CAPITALStated: "After experiencing market volatility, we will view this track more calmly, neither blindly following hotspots nor fearing disruptive new technologies. For the 5 million existing valvular disease patients in China, polymer valves are a more ideal solution compared to the significant shortcomings of current mechanical or biological valves. Over the past few decades, with advancements in material science and continuous attempts in polymer valve development, we have finally seen the emergence of valve products that are cheaper, longer-lasting, and carry lower clinical risks for patients. Meanwhile, under the leadership of Xinrui Medical's professional and pragmatic team, we believe that China's independently developed and innovative polymer valves will also join the global forefront of research and development, bringing new hope to patients."

Yu Fang, Partner of Northern Light Venture CapitalStated: "As the lead investor from the previous round, we continue to be optimistic about the development of Xinrui Medical's team and products. Polymeric heart valves are a new type of heart valve that offer better durability, lower risk of thrombosis, and smaller gaps compared to traditional mechanical and biological heart valves, providing improved patient outcomes. With the increasing aging population and the rising incidence of cardiovascular diseases, this new type of heart valve is well-positioned to meet the growing demand from patients."