Entering Clinical Trials in Three Years! The International Vision of magAssist and Chinese Speed

Source: 36kr.com, by Shuning CAI

“Second in the World, One and Only in China”

It’s learned that artificial heart R&D company magAssist recently announced its completion of Series B financing of over RMB 100 million. This financing was led by Northern Light Venture Capital, followed by SND Ventures and supported by existing shareholders like Guoqian Venture Capital, Anji Yunshuo and TigerYeah Capital.

International Cutting-edge Technology: Helping Severe and Critical Patients Gain a New Heart

The heart, like a dynamo of life, is the most important organ of the human body.

However, an extensive number of patients are facing a wide range of heart problems. China has 330 million patients with cardiovascular diseases, the leading cause of all deaths. One major category is heart failure, which has affected 26 million people worldwide. Heart failure is known as the “cancer among heart diseases”, and approximately 50% of patients with heart failure in advanced stage (NYHA Class III and IV) die within 2 years. For patients in advanced stage, the current mainstream treatment is heart transplantation. Due to the lack of donors, however, only about 500 heart transplants can be performed in China every year. Under such circumstance, artificial hearts have brought new possibilities to patients.

Life may also be threatened by acute diseases and accidents, such as COVID-19, H1N1, serious car accidents, drowning, gas poisoning, myocardial infarction, and cardiogenic shock of unknown origin after thoracotomy. For this group of patients, an extracorporeal artificial heart is a life-saving emergency treatment and treatment measure which can increase the survival rate by 50%.

Artificial heart is a life-saving technology that is urgently needed by the society, but it’s truly mastered by only a handful of companies due to the high threshold of research and development. MagAssist is centered on the research and development of short and medium-term extracorporeal ventricular assist devices (“short and medium-term extracorporeal artificial hearts”) which can be used in the supportive treatment of acute heart failure due to various causes and transitional treatment of patients with end-stage heart failure, and extensively applied to the treatment of perioperative critical patients in cardiac surgery.

The development of artificial hearts integrates multi-disciplinary technologies, spanning across mechanics, electronics, power control, fluid mechanics, materials science, clinical medicine, foundation medicine and biology. Such extensive involvement of technologies has also brought about many challenges to the design and manufacturing of artificial hearts. For example, the distance between the magnets at both ends of the motor should be as small as possible within a certain range, but the distance between the two ends of the blood pump should be as large as possible in a certain range to prevent blood cells from being squeezed.

The artificial heart industry is presented with many technical contradictions caused by interdisciplinary research, which is a common problem faced by researchers. In response to these industry problems, magAssist offers the following solutions and advantages: 

For one thing, magAssist has built a multi-disciplinary R&D team to give the best interdisciplinary solution. Dr. HSU, founder and CEO of magAssist, is an expert of the Youth Group of the National Key Talents Project, the first Chinese board member of the International Society for Mechanical Circulatory Support (ISMCS), a distinguished professor and doctoral supervisor of Soochow University. The magAssist team is an international team long engaged in artificial heart research and development, and magAssist has independently built mechatronics, maglev and computational fluid dynamics and other core platforms.

For another thing, magAssist has internationally leading iteration speed. It only took magAssist about three years to complete the research and development of the first Class III high-technology barrier active product, namely, the maglev extracorporeal artificial heart, from scratch. The product passed the preliminary review of the Clinical Ethics Committee of Wuhan Union Hospital of China in December 2020 and will be soon put into clinical trial.

R&D Progress: China’s First Maglev Extracorporeal Artificial Heart to be Put into Clinical Trials

For industries with high technology barriers, R&D and clinical progress are the core concerns of market review.

Currently the first product of magAssist is the maglev extracorporeal artificial heart, the R&D progress of which is industry-leading and can be summarized as “second in the world and one and only in China”. With finalization of design in 3 years, the product complies with regulatory inspection standards. Through cooperation with Professor Nianguo DONG’s team of Wuhan Union Hospital of China, it will be put into clinical trials in the Hospital recently. 

In this segment, there is currently only one product on the market in the world—Abbott’s full maglev blood pump product CentriMag. According to the founder of magAssist, the product of magAssist is similar to CentriMag in terms of core functional indicators, and offers better performance in human-factors engineering, system integration and multi-scenario applications, and can be applied to emergency treatment, patient transfer and disaster scenarios in addition to ICU (application scenario of CentriMag).

Another hit product of magAssist is the interventional artificial heart which is mainly used in high-risk percutaneous coronary intervention (PCI) surgery to protect patients and maintain hemodynamic stability. This product is developed with Academician Junbo GE of Shanghai Zhongshan Hospital, the animal experiment results of which will be released soon. It’s benchmarked against the product of U.S. stock market listed company Abiomed.

It is worth noting that the heart stent related to PCI surgery is one of the first batch of consumable materials of which the government made volume-based procurement this year. Through centralized procurement, 10 domestically made and imported stents were selected, and the average price sharply decreased from about RMB 13,000 to about RMB 700, with a drop of 93%. According to magAssist, there are more than 1 million PCI cases in China every year, of which at least 100,000 are high-risk PCI cases. The increased accessibility of heart stents and other related medical devices will, to some extent, increase the demand for artificial hearts. That’s because patients may experience atrial fibrillation, ventricular fibrillation, and cardiac arrest when stents or valves are placed. Therefore, treatment of heart failure in high-risk patients needs to be enhanced, and pumps can be turned on to maintain blood circulation.

As revealed by magAssist, the critically ill patients are faced with complex clinical situations and have personalized needs. For example, some need protective products or transitional products, and others require permanent substitute products. Hence, magAssist plans to build a short and medium-term life support platform to provide kits satisfying different user needs. All products will be designed with adaptive interfaces to ensure the safety of product switching. In response to rigid clinical demand for life support devices for acute cardiogenic shock and severe acute organ failure, magAssist has first launched such major product lines as maglev extracorporeal artificial heart, interventional artificial heart and new-generation ECMO.

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