Yongrenxin Medical Announces IPO Filing Following the Launch of Its Heart Failure Treatment Park and Success of EVAHEART Artificial Heart

2023 Advanced Heart Failure Summit and EVAHEART Medical Science Park Inauguration Successfully Held on March 17

Hu Shengshou, Academician, President of Fuwai Hospital, Chinese Academy of Medical Sciences, and Director of the State Key Laboratory of Cardiovascular Disease; Luo Li, Deputy Director of Chongqing Municipal Commission of Economy and Informatization; Pi Tao, Member of the Working Committee of Chongqing Liangjiang New Area and Deputy Director of the Management Committee; Chen Liang, Secretary of Fujian Medical University Union HospitalMillion, Ai Yang, Vice President of Chongqing Charity Federation, Chongqing CurrentYang Liqiong from the Industry Development Research Institute, Zhang Ke (Deputy General Manager of Chongqing Liangjiang Industry Group), Shan Fu (Managing Partner, Co-CEO, and Greater China CEO of Vivo Capital), Jinhua Jin (General Manager of Strategic Investment at Sinovac), Tang Liang (Deputy General Manager of Investment Management Department at Taiping Life Insurance Co., Ltd.), Li Yangchun (President of Chongqing Pharmaceutical Industry Association), Hua Yan (Director and CEO of EVAHEART), and Benyan Zhang (Founder, Director, and General Manager of EVAHEART) were among the clinical experts, government representatives, and prominent investors attending this meeting. Additionally, numerous doctors participated in this event both online and offline.

According to the introduction, the conference, themed "EVAHEART in Motion, Benevolence in Action," focuses on the development of the heart failure and critical care industry. It aims to build a multi-party exchange and cooperation platform to jointly promote and standardize health management in the field of heart failure and critical care, benefiting the life, health, and quality of life of the Chinese people. Additionally, under the witness of the guests present, the EVAHEART Medical Science Park was officially established.

Academician Hu Shengshou stated in his speech: "With the development of an aging population, the situation for diagnosing and treating heart failure patients is becoming increasingly severe. The advent of artificial hearts has brought new hope to patients with end-stage heart failure, providing help to many whose lives are nearing an end. The approval and market launch of EVAHEART marks China's entry into the era of artificial hearts for heart failure treatment. Its efficiency is unmatched by any drug therapy, and from this perspective, there is no doubt that the artificial heart is a life-saving medical device."

(Academician Hu Shengshou)

EVAHEART's Director and CEO, Hua Yan, stated: "From its establishment to the present, EVAHEART has been through a full nine years. During this period, EVAHEART has witnessed the development of China's artificial heart industry and has also made its own contributions to the industry. Now,EVAHEART, the artificial heart product of EVAHEART Medical, has been widely applied across more than twenty provinces in China, increasingly becoming an effective treatment for severe heart failure. As the first company in China to receive approval for an artificial heart, EVAHEART Medical's product EVAHEART is currently the only left ventricular assist device in China approved for long-term auxiliary indications.From the very beginning,EVAHEART"Only by firmly collaborating with clinicians, listening to their opinions, and continuously innovating technology, have we finally achieved the current results and accomplishments."

(EVAHEART Medical Director and CEO Yan Hua)

In 2022, EVAHEART delivered frequent good news, leading the industry in market expansion and gaining recognition from doctors for its clinical applications.Synchronously launched a revolutionary and world-leading tipless intravascular design.At the same time, EVAHEART has also completed a nearly 100-million-dollar financing round against the trend during the capital winter period. This financing event is one of the few ultra-large financing events in the global innovative medical device field in the past year.

Yan Hua stated: "We will continue to efficiently promote the research, registration, and market launch of various new products on the EVAHEART platform for severe heart failure treatment; deepen our collaboration with government agencies, clinical experts, insurance companies, and charitable organizations; and continue to benefit patients and contribute to health planning."

At the conference site, under the witness of prestigious representatives from the medical, political, and corporate sectors—including Academician Shengshou Hu, President of Fuwai Hospital, Chinese Academy of Medical Sciences; Li Luo, Deputy Director of the Chongqing Municipal Commission of Economy and Informatization; Tao Pi, Deputy Director of the Liangjiang New Area Party Working Committee and Management Committee; Liangwan Chen, Secretary of Fujian Medical University Union Hospital; Shan Fu, Chairman of EVAHEART; and Hua Yan, Director and CEO of EVAHEART—EVAHEART Science Park Officially Announced。

It is reported that the EVAHEART Science Park will be located in Shuitu New City, Liangjiang New Area, Chongqing, for expanding existing product lines as well as future new technology research, localized production in China, and will be gradually completed.An industrial chain cluster integrating "government, industry, academia, medicine, and research"。

Fu Shan, Managing Partner, Co-CEO and Greater China CEO of Vivo Capital, and Chairman of EVAHEART, stated: "This science park is planned to be the future global main production base for EVAHEART. The company will establish a total assembly production line for artificial hearts and precision processing production lines for key components in the science park, enhancing production capacity and core technical levels, and supplying artificial heart products to global markets including China, Japan, the European Union, and the United States."

(Fu Shan, Managing Partner, Co-CEO and Greater China CEO of Vivo Capital, Chairman of EVAHEART)

At the same time, EVAHEART will gradually introduce advanced high-end medical devices for the treatment of severe heart failure from overseas, and achieve independent research, development, and production of innovative products, creating a series of product clusters for the diagnosis and treatment of severe heart failure.

In addition, EVAHEART will focus on severe heart failure, establishing a full industrial chain platform covering disease screening, remote monitoring, precise diagnosis, short-term surgical assistance, and long-term treatment, providing medical institutions and patients with short-term to medium- and long-term treatment solutions.

It should be noted that,The reason for expanding production capacity and building new production lines is that EVAHEART, the artificial heart product independently developed by EVAHEART Medical, has been rapidly applied in clinical settings and has received unanimous praise from clinicians.。

For example, Professor Yang Yan from the First Affiliated Hospital of Xi'an Jiaotong University performed 10 artificial heart implant surgeries in the past year, all using EVAHEART. The numerous advantages of EVAHEART have left a deep impression on clinical experts.First, EVAHEART has a lower rotational speed, causing minimal damage to blood. The clinically applicable speed is 1600-1800rpm, significantly lower than other similar products. The entire flow path inside the pump adopts a large-diameter (16mm inner diameter) pipeline design. The blood pump features a gentle H-Q curve, with a flow rate reaching 20L/min in the low-pressure region.

Second, as a bionic continuous-flow artificial heart capable of generating physiological pulsatile blood flow, EVAHEART preserves the patient's heartbeat and pulse, reducing the risk of complications such as right heart failure, aortic valve insufficiency, arteriosclerosis, gastrointestinal bleeding, and vWF factor deficiency, while improving the patient's quality of life.

Third, EVAHEART adopts the hydrodynamic suspension technology introduced from Japan. The pump contains no unnecessary electronic components or sensors, which can minimize the risk of component failure. Its design utilizes non-contact rotating hydrodynamic bearings, achieving high durability with a designed lifespan of up to 30 years. The longest use by an overseas patient exceeds 10 years.

Fourth, compared with other products, EVAHEART has an extremely low rotation speed. Combined with a curved impeller designed using fluid mechanics, it causes less hemolysis, lower clotting activation, and the content of vWF factor is close to normal. The blood-contacting surfaces inside the blood pump are coated with a biomimetic MPC coating, which simulates the surface of vascular endothelial cells and possesses excellent antithrombotic functionality. It exhibits high affinity characteristics with water molecules.

As of now,EVAHEARTEVAHEART is the only artificial heart in China that has been approved for both short-term and long-term treatment indications. It has also been approved for marketing in Europe and Japan, and has obtained FDA IDE approval in the United States.。

Yan Hua stated: "The low speed and high flow characteristics of EVAHEART provide strong support for patients with severe heart failure; its excellent physiological pulsatility transforms a cold metal pump into a warm, pulsating artificial heart."

Perhaps based on EVAHEART's product advantages and leading position, it successfully completed a nearly 100-million-dollar Series A round of financing against the trend during the 2022 capital winter period, led by Sinovac, with Taiping Innovation Fund following the investment, and Vivo Capital continuing to increase its investment.It is reported that this financing is one of the few ultra-large financing events in the field of global innovative medical devices in nearly a year.。

(Strategic Financing Signing Ceremony)

Heart failure is the end stage of the development of various heart diseases, known as "the last battlefield of cardiovascular diseases."

From the perspective of patient numbers, there are currently about 22 million people worldwide suffering from heart failure, including approximately 13 million patients in China, with more than 700,000 critically ill patients. In terms of disease impact, the mortality rate of heart failure is comparable to that of malignant tumors, with a 5-year survival rate of only around 30%.

In terms of treatment, heart transplantation and artificial hearts are currently the best treatment options for severe heart failure patients. However, heart transplantation faces issues such as a lack of donors. For example, from 2015 to 2020, China reported a total of 2,819 heart transplant surgeries, with annual numbers being 279, 368, 446, 490, 679, and 557 cases respectively. Despite the increasing number of heart transplants, it remains insignificant compared to the 13 million heart failure patients and 700,000 critically ill patients.

Despite a steady increase in the number of heart transplants, there remains a significant gap between the number of heart transplant surgeries and the number of patients with refractory heart failure.

Fortunately, the approval and market launch of EVAHEART will bring new hope to heart failure patients worldwide. Today, artificial heart technology has become one of the standardized treatment methods for heart failure recommended by international medical guidelines. EVAHEART is also expected to seize this opportunity to accelerate its growth and help more heart failure patients.

Notably, although EVAHEART by Yongrenxin has demonstrated clear clinical advantages and gained expert recognition, some patients are still unable to opt for artificial hearts due to financial constraints. In response, EVAHEART Medical, in collaboration with the Chongqing Charity Federation and Taiping Life Insurance, launched the 2023 "Benevolent Heart Initiative" patient care program. This initiative aims to assist heart failure patients facing economic hardships and prevent them from falling back into poverty due to illness. In the future, with the support of medical insurance, commercial insurance, and charitable organizations, artificial hearts are expected to offer a new lease on life to more heart failure patients.

During the conference, the "2023 China Heart Failure Industry White Paper," jointly compiled and organized by 17 hospitals and research institutions in China, was重磅 released, providing us with more precise and efficient means to better understand the harm, prevention, and treatment of heart failure. Heart failure is considered the final battlefield in the treatment of cardiovascular diseases. Humanity has made significant progress in the treatment of heart diseases, but heart failure (HF) is an exception—it is the only cardiovascular disease that is still on the rise. There has been no previous "white paper" on the current state of severe heart failure treatment, mainly because the causes of heart failure are very complex, and many technologies are still in the exploratory stage.

The release of this white paper provides an overall standardization in areas such as epidemiology, treatment models, and contributing factors. It systematically reviews various therapies for severe heart failure treatment. The content of the white paper includes emerging technologies, differences in treatment between China and abroad, and future research directions. This document offers crucial references for future choices in heart failure treatment, new technology development, and the integration of medical engineering. It will also bring more attention to the field of heart failure, raise awareness about patients with severe heart failure, and encourage greater investment of resources into the heart failure domain.

At the conference, Professor Wang Xianqiang from Fuwai Hospital of the Chinese Academy of Medical Sciences, Professor Yan Yang from the First Affiliated Hospital of Xi'an Jiaotong University, Professor Dai Xiaofu from Union Hospital of Fujian Medical University, and Professor Sang Ling from the First Affiliated Hospital of Guangzhou Medical University delivered academic presentations, explaining the successful application of artificial heart technology, innovative heart failure technologies, and critical care support techniques in patients with heart failure and severe conditions.

Finally, EVAHEART awarded honorary certificates to clinical experts who have made significant contributions to the promotion and popularization of artificial heart implantation technology. With the support and promotion from clinical experts, the number of artificial heart implants is expected to grow rapidly. EVAHEART will also leverage its product advantages and reputation to win the market.