World's Smallest Percutaneous Ventricular Assist Device NyokAssist® Enters China's Innovation Review Pathway

Jan 23, 2024 10:59 CST Updated 10:59

magAssist

Developer of Extracorporeal Artificial Heart Devices

Source of the article:Heart NotCome;Editor: Bai Xiaofei

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Heart's Future

Recently, the Center for Medical Device Evaluation released a notice, and Document No. 1 of 2024 announced seven medical devices entering the innovation channel, includingmagAssistTheInterventional Ventricular Assist System (NyokAssist®). In August 2023, the systemObtainFDA Breakthrough Device（Breakthrough Device）Recognition, becomingThe First in ChinaThe Interventional Artificial Heart Granted This Designation。

World's Smallest Interventional Artificial Heart Receives FDA "Breakthrough Device" Designation

In July 2023, magAssist's extracorporeal fully magnetically levitated artificial heart and new-generation extracorporeal membrane oxygenation system (ECMO) shared integrated device platform were approved as innovative medical devices in China, entering the "green channel" for market approval.As the interventional artificial heart NyokAssist® enters the innovation channel, magAssist's multi-organ life support platform enters a phase of comprehensive advancement., looking forward to serving patients in China and even around the world in the near future.

# Overview of the Interventional Artificial Heart Market

Implantable Artificial HeartBlood flow can be increased, blood perfusion enhanced, and myocardial oxygen consumption reduced in different ways to help patients with acute heart failure improve cardiac pumping function in a short period of time.Protective Measures for High-Risk Percutaneous Coronary Interventions (HRPCI), its interventional size is highly correlated with vascular complications, bleeding, transfusion, and severe adverse cardiovascular events.

The interventional artificial heart can treat patients through minimally invasive intervention.Smaller wounds, lower harm, and relatively shorter support time when operating inside the body., applicable for acute myocarditis with poor response to conventional treatment, cardiomyopathy with shock, refractory heart failure, cardiogenic shock caused by AMI, and high-risk PCI perioperative support, etc.

It is reported that heart failure associated with interventional artificial hearts represents the end stage of cardiac disease development, with a five-year mortality rate as high as 30-70%, and is widely recognized as "the last battlefield in the field of cardiovascular disease."According to public data, there are nearly 30 million heart failure patients globally.China has approximately 10.67 million heart failure patients.It is expected that with the extension of survival period of patients with heart disease and the deepening of aging,The Number of Heart Failure Patients Will Continue to Grow。

Data released by market research firm ReportLinker shows:The global heart failure treatment device market is expected to reach 14 billion US dollars by 2025.The Market Size of Heart Failure Management in China Will Exceed 10 Billion。

In the global market, restricted by the high technical threshold of invasive artificial hearts, onlyA few companies are laying out, andJohnson & Johnson's Impella isCurrently the only one approved by the U.S. FDAPercutaneous Heart Pump Technology，The intervention size is 14Fr, which can easily lead to vascular complications and is not conducive for patients with vascular stenosis.Only in 2023,Impella Recalled by FDA for Two Consecutive Months with Class I Recall. In order to address the related drawbacks, Johnson & Johnson's latest generation product focuses on reducing the interventional size as its iterative direction. This shows that,Smaller Interventional SizeIs the core point for internationally top-tier medical device technology companies seeking technological breakthroughs.。

Looking at the domestic market again, Impelle has not yet entered the Chinese market in the field of interventional artificial heart devices,There is a blue ocean market with untapped potential waiting to be explored in China.。

# NyokAssist® Interventional Artificial Heart

NyokAssist® Interventional Artificial Heart, developed by magAssist in collaboration with the team of Academician Ge Junbo from Fudan University's Zhongshan Hospital in response to the national call, throughMedical-Engineering ConvergenceAchieve integrated innovation.

▲Image SourceOfficial CompanyNet

NyokAssist® Interventional Artificial Heart Features a Foldable Impeller Design, OfferingSmallest Intervention Size (9Fr, 3mm) Among Similar Products Worldwide, canMinimize bleeding and reduce the occurrence of perioperative and postoperative vascular complications.`, and can`Meet the usage needs of patients with finer blood vessels or arterial stenosis。

After entering the body, the impeller can quickly expand to an operating size exceeding 21Fr, thereby achieving higher flow rates while running at a lower speed.Reduce the damage to blood cells caused by the high-speed rotation of the impeller。NyokAssist® External Motor Design Effectively Avoids Hemolysis Caused by Internal Motor Heating, the volume of HRPCI surgeries in China is enormous, which willHigh-value motors, as reusable components, can effectively reduce costs., with significant value in health economics.

▲Image SourceOfficial CompanyNetwork

▲9Fr Interventional Size is the Smallest in the Industry

▲Rapid expansion and release after entering the body

▲Foldable impeller design enables greater flow at lower speeds.

▲ External motor placement avoids heat-induced hemolysis when placed inside the body and allows for repeated use, reducing costs.

# magAssist

magAssist (Suzhou) Co., Ltd. (referred to as: "magAssistFounded in 2017, magAssist was initiated by Dr. Bo-Ling Xu, a distinguished professor at Soochow University, member of the national talent program, and the first Chinese committee member of the International Society of Mechanical Circulatory Support (ISMCS). The company was co-founded with a top expert team from home and abroad who have long been engaged in the development of artificial organs.。

magAssist is committed to buildingA New Generation Life Support Platform for Emergency and Critical Care Scenarios, now has4 Heavyweight Product Lines：The world's smallest interventional artificial heart, China's first extracorporeal full magnetic levitation artificial heart, a new generation of portable ECMO system, and a warm-blood organ transport platform,After more than 6 years of establishment, magAssist has grown intoOne of the companies with the most comprehensive product lines and fastest R&D progress in the field of life support in China., with a total of 300 patent applications submitted, accounting for 1/4 of the total number of artificial heart patent applications in China, and has initially built up a moat of independent research and development in the field of advanced life support.

As of the date of publication,magAssist has completed 6 rounds of financing, with a total amount of up to hundreds of millions of yuan., wherein the Series A funding was nearly RMB 10 million, Series B exceeded RMB 100 million, and Series C was approximately RMB 500 million. It not only attracted continuous investment from Guoqian Venture Capital and Taiyu Investment but also secured a leading investment from top-tier capital Sequoia China. The company's financing history is as follows:

Overseas Cardiovascular Devices:

Products of Chinese Cardiovascular Companies: