Vivo Capital Completes Controlling Acquisition of Relin Heart with Tens of Millions in Initial Investment to Advance Innovative Heart Failure Therapies

VCBeat has learned that the only R&D and manufacturing enterprise in China currently approved to market an implantable left ventricular assist system (hereinafter referred to as the "artificial heart") — Chongqing EVAHEART Medical Device Co., Ltd. (hereinafter referred to as EVAHEART) — has successfully completed a strategic restructuring, with Vivo Capital completing a controlling acquisition of EVAHEART through an investment of tens of millions of US dollars.

Following this acquisition, EVAHEART will fully leverage the capital injection and resource synergy from Vivo Capital to invest in the R&D and innovation of next-generation artificial hearts, the clinical and commercial application of its products, and the introduction and localized production of additional medical devices for heart failure treatment.

In August 2019, the implantable left ventricular assist system EVAHEART (hereinafter referred to as the EVAHEART artificial heart), developed and manufactured by EVAHEART, obtained the medical device registration certificate issued by the National Medical Products Administration (NMPA). It is indicated to provide mechanical circulatory support for patients with advanced refractory left heart failure, serving as a bridge to heart transplantation or recovery of cardiac function, as well as for long-term therapy. The EVAHEART artificial heart is the only artificial heart product approved for market launch in China. The approval of this product signifies that EVAHEART has filled a gap in China's artificial heart field. Currently, the EVAHEART artificial heart has been clinically applied in multiple top-tier hospitals across China.

Fu Shan, Managing Partner at Vivo Capital and Chairman of EVAHEART:

"Date with China"13 millionPatients with Heart Failure. Currently, despite intensive treatment with existing heart failure medications and devices, the five-year mortality rate for patients across all types of heart failure remains as high as 30–70%. Among treatment options for advanced heart failure, heart transplantation is currently recognized as the only effective therapy for patients with end-stage heart failure; however, the severe scarcity of donor hearts significantly limits the implementation of transplant procedures. To save patients with heart failure and overcome the shortage of donor organs, the medical and scientific communities have collaborated to develop artificial hearts as an alternative solution.

As a globally leading healthcare-focused investment firm, Vivo Capital has long prioritized therapeutic solutions for heart failure. Incorporating advanced technology introduced from Japan, the EVAHEART artificial heart stands as the safest among clinically utilized artificial hearts worldwide and remains the only such product approved for commercial launch in China. Vivo Capital’s acquisition of Chongqing EVAHEART aims to enhance the domestic production capabilities of this device, advance the R&D of next-generation technologies, and ultimately benefit a broader population of patients with severe heart failure.

Since the establishment of Chongqing EVAHEART, Chairman Zhang Benyan of Chongqing Lilong Group and the Japanese HI-LEX team have been dedicated to introducing this technology to China, laying the foundation for the regulatory approval of the EVAHEART artificial heart. Backed by a solid R&D foundation and stringent manufacturing processes, the EVAHEART artificial heart can not only provide bridge-to-transplantation or bridge-to-recovery therapy, but also offer lifelong destination therapy, positioning it to become a core force in the heart failure treatment landscape.

Vivo Capital is deeply impressed by EVAHEART’s robust production and quality control systems, and is committed to working alongside all new and existing shareholders to elevate the company to a new level of development. Furthermore, building on the foundation of the EVAHEART artificial heart, Vivo Capital will introduce additional strategic partners and internationally leading medical device products to EVAHEART. With the continued strong support from national and local governments, the company will leverage the clustering effect of the industrial chain to transform EVAHEART into a comprehensive medical device platform for heart failure care and cardiac disease treatment in China.

Zhang Benyan, Founder and Director of EVAHEART:

Following this strategic restructuring, it will be more conducive to Chongqing EVAHEART advancing a robust market strategy. Across the three dimensions of "technology, market, and capital," the company will comprehensively seize strategic initiative and command strategic high grounds, striving to achieve the strategic goal of "scaling up and becoming stronger." We hope that Chongqing EVAHEART will make its due contributions to advancing the reform and innovation of the healthcare system under the "Healthy China" initiative and to boosting the revitalization and development of China's strategic emerging medical device industry.

Director of Chongqing EVAHEART andCEOXu Xu:

Alongside advancing the sales of EVAHEART products, Chongqing EVAHEART is efficiently expediting the regulatory registration process for its second-generation miniaturized device. Featuring a smaller and lighter design, expanded patient eligibility, and reduced surgical complexity, the second-generation EVAHEART product will make a substantial market impact upon commercialization. It is firmly expected to save more lives among patients with severe heart failure. Looking ahead, Chongqing EVAHEART will progressively implement the domestic localization of components for the second-generation product to drive down costs. Concurrently, it plans to forge technical and capital partnerships with global medical device industry leaders, thereby introducing more high-quality medical device projects. These initiatives will cultivate an internationally leading industry cluster for cardiovascular therapeutic devices, delivering comprehensive, full-cycle systematic solutions for cardiovascular disease treatment.

(Left: first-generation product; Right: second-generation product)

As the final frontier in cardiovascular disease, heart failure has long been one of the conditions that medical science most urgently seeks to conquer. However, contrary to expectations, its prevalence continues to rise. Publicly available data indicate that there are approximately 13 million heart failure patients in China, among whom those with severe heart failure account for about 5%, totaling 600,000 to 700,000 individuals. Furthermore, the 5-year survival rate for heart failure patients stands at merely 35%, while for those with end-stage heart failure, it is only 20%.

Available data show that since 2006, over 25,000 patients in North America have undergone implantation of ventricular assist devices (VADs). Since 2013, the annual number of VAD implantations has consistently exceeded that of heart transplants. In recent years, the global left ventricular assist device (LVAD) market has expanded rapidly, at an average annual growth rate of 15.21%. In 2018, the global LVAD market size reached nearly USD 1.56 billion. It is foreseeable that artificial hearts, as an effective treatment for heart failure, will be rapidly adopted and widely deployed in the future.

Previously, only developed countries and regions such as the United States, Europe, and Japan possessed complete artificial heart technology. To swiftly fill the gap in China regarding the research, development, manufacturing, and clinical application of artificial hearts, EVAHEART has introduced a comprehensive suite of mature overseas technologies to establish itself as the premier brand for artificial hearts produced in China.

Founded in 1996, Vivo Capital is a leading global healthcare investment firm with a diversified multi-fund platform spanning venture capital, growth equity, acquisitions, and public equities. With $5.8 billion in assets under management, the firm has invested in over 290 public and private companies worldwide. Headquartered in Palo Alto, California, the Vivo team comprises more than 50 multidisciplinary professionals. Through various fund strategies, Vivo Capital invests broadly across the healthcare sector—including biotechnology, pharmaceuticals, medical devices, and healthcare services—with a primary focus on the world's largest healthcare markets.

Founded in 2014, Chongqing EVAHEART is an innovative enterprise specializing in the research, development, and manufacturing of artificial hearts. The EVAHEART artificial heart has been clinically applied in over 200 cases overseas, with the longest circulatory support duration reaching 10.5 years. In 2018, the clinical trial for the EVAHEART artificial heart, led by Academician Hu Shengshou’s team at Beijing Fuwai Hospital and jointly conducted by top-tier hospitals such as Wuhan Union Hospital and Fujian Union Hospital, achieved outstanding clinical outcomes: zero mortality during the trial, no serious device-related complications, and a 100% one-year postoperative survival rate. To date, the longest circulatory support duration for patients in China has exceeded three years.

Due to its innovation and urgent clinical necessity, the EVAHEART artificial heart was awarded the “2019 Major Medical Advances in China” certificate by the Chinese Academy of Medical Sciences in 2020, and received the honor of being selected for CCTV.com’s “2019 Top Ten Scientific and Technological Achievements in China”.

The EVAHEART artificial heart employs a centrifugal pump and a unique pure-water seal design. Featuring technical characteristics such as low rotational speed, high flow rate, high durability, and excellent biocompatibility, it causes minimal blood trauma. With a maximum flow rate exceeding 20 L/min, it is a continuous-flow assist artificial heart capable of generating physiological pulsatile blood flow. This feature helps reduce the risk of complications such as right heart failure, aortic regurgitation, gastrointestinal bleeding, and von Willebrand factor deficiency, thereby improving patients' quality of life.

In addition, EVAHEART has already initiated the development of its second-generation product. Compared to the first generation, while retaining all the superior features of the existing blood pump, it successfully achieves miniaturization and weight reduction of both the blood pump and the extracorporeal controller. This not only expands the eligible patient population but also simplifies the surgical procedure, reduces surgical trauma, and lowers the required intensity of anticoagulation. Meanwhile, the drive cable has been made thinner, alleviating pressure on the skin at the percutaneous exit site and thereby reducing the risk of infection.