magAssist
Transforming Life Support Device Industry in China

According to the National Library of Medicine, every year, 500,000 new heart failure (HF) cases are diagnosed in China, accounting for an incidence of 0.9 percent.

Although mechanical circulatory support (MCS) is an alternative for acute cardiogenic shock (CS) patients in China, it has limited availability.

Domestic high-end life support devices are mostly imported, and the supply is far less than the demand. Some devices are still in a vacuum state with zero imports. Due to this, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support has gained popularity in recent years. However, ECMO’s high complication rates and costs underscore the need for a safer, more effective, and targeted MCS therapy for CS.

The urgent demand of doctors for the localization of extracorporeal life support equipment greatly encouraged Dr. Po-Lin Hsu, Founder, and CEO of magAssist, to start her business. The genesis of magAssist Inc., a leading advanced medical device company in China, is driven to meet clinical demand while providing a comprehensive source of life support to clinicians.

Motivated to transform technology into products for the benefit of the patients, Dr. Hsu founded magAssist in 2017. Her entrepreneurial journey began with the intention to develop the first domestic and international level of shortand medium-term extracorporeal ventricular assist devices in China. Even though the artificial heart is one of the most technologically advanced medical devices, Dr. Hsu noticed that there is still a gap between China and foreign countries due to technological and economic constraints.

Moreover, heart transplantation is the best treatment option for patients with end-stage heart failure. Yet, due to the shortage of heart donors, the potential waiting time for patients is very long, which means patients with severe heart failure may have life-threatening problems at any time during the waiting process. The establishment of extracorporeal circulatory support provides help for heart failure patients and secures safety during the process of waiting for donor hearts, which also ensures more time for patients.

“We are changing how clinicians treat patients by bringing better technology into the market,” says Dr. Hsu.

Due to its extraordinary achievements in extracorporeal life support, magAssist has stood out in the biotechnology and healthcare sector. During the three-year-development, the company completed the first MoyoAssist^® Extra-VAD engineering prototype in China, realized large animal experiments, and achieved the expected results. At the same time, the company’s GMP plant was opened, and it has the first production line of extracorporeal magnetically levitated ventricular assist devices in China.

While treating heart failure, magAssist also addresses different stages of heart failure and its associated complications. Cardiogenic shocks hinder a heart’s capacity to pump blood for oxygenation, nutrition, and other needs, affecting kidney and lung function.

magAssist is solving this clinical need with its maglev artificial heart pump and comprehensive portfolio of extracorporeal life support systems. It places the maglev system at the heart of its solutions to treat heart failure and associated risks. MoyoAssist^® Extra-VAD keeps heart failure patients alive while awaiting interventions such as heart transplants. A patented, magnetic impeller mimics a natural heart, reducing blood cell damage common in traditional pumps.

“Our product synergy boosts the clinical benefit a single product cannot otherwise achieve,” adds Dr. Hsu.

Its maglev artificial heart technology eliminates contact bearing by leveraging a rotating impeller that floats in the chamber, unlike contemporary artificial hearts that employ rotary pumps with mechanically contracting bearings to propel the impeller that pumps blood into the vessels.

This allows its solutions to avoid the dangers of friction caused by rotating components of conventional artificial heart systems. At the same time, the device uses computational fluid dynamics to optimize flow paths by streamlining the entire flow field, making the device exceedingly blood-friendly. Through this capability to ensure minimal blood damage, patients can use maglev for extended periods without significant problems, lowering ICU costs and mortality rates.

As the first product of a young start-up, using a foreign design firm for the first time, the magAssist VAD heart pump is a remarkable ‘moonshoot.’ Not only is the first of its kind to be developed for the Chinese market, but the product also leapfrogs the leading devices from established US and EU incumbents. While MoyoAssist^® Extra-VAD core function matches the market benchmark (Abbott’s CentriMag), magAssist’s unique design offers better human-factors performance and system integration, allowing it to suit multiple scenarios beyond ICU environments, including emergencies and patient transfers. More importantly, it is positioned to deliver this technology at a far more accessible price.

To maintain high precision levels in medical products manufacturing, magAssist works with vendors to improve its engineering process. Its focus and precision in manufacturing enable it to provide hybrid circuit boards at a reasonable cost, which is unconventional in China’s medtech industry.

“The way technology can fulfill clinical needs is what creates value,” says Dr. Hsu.

magAssists’ current portfolio comprises MoyoAssist^® Extracorporeal Ventricular Assist Device (Extra-VAD), NyokAssist^™ Percutaneous Ventricular Assist Device (pVAD), BreathMoAssist^™ Extracorpreal Membrane Oxygenation System (ECMO), and DonorLife^™ Organ Care System.
The first high-tech class III product from magAssist, MoyoAssist^® Extra-VAD, is a domestically-made extracorporeal magnetic levitation artificial heart independently developed in China.

MoyoAssist^® is appropriate for patients with acute CS, PCCS, BTT, and bi-ventricular heart failure, since it adapts to diverse cannulation techniques and challenging clinical situations. It comprises a single-use centrifugal pump head, a maglev motor, and a console.

It introduces a ventricular assist device innovation and offers an option to existing ECMO patients without respiratory failure. Medical professionals have also indicated that Extra-VAD does not require blood transfusions and causes significantly less harm to blood cells, providing a successful procedure. The third-generation maglev pump’s improved flow path design ensures safety and stability while lowering hemolysis rates and the dangers of device-related thrombosis. MoyoAssist’s portable design makes patient transfers and mobility easier.

MoyoAssist^® is also anticipated by Chinese healthcare professionals as a locally-developed product, which has already participated in breakthroughs of China medical science. It is capable for accessing with percutaneous procedure via jugular vein, which may minimize surgical harm to patients and allows them to achieve upper-body cannulation without affecting the patient’s mobility. The patients would be able to eat or even exercise during their wait of donor hearts. This approach was first developed by Professor Nianguo Dong’s team at Wuhan Union Hospital. Recently at 2022 Critical Heart Disease Congress & International Society for Mechanical Circulatory Support Parallel Forum, Professor Nianguo Dong and his team shared about their clinical experience of using MoyoAssist^®. According to Dong, up till December 2022, there have been over half of the cases of using MoyoAssist^® were accessed via percutaneous approach.

In one of the cases, a 24-year-old male patient with dilated cardiomyopathy, NYHA class IV, and end-stage heart failure was admitted to Wuhan Union Hospital. During the waiting period, his condition gradually aggravated. Eventually, the patient was transferred to the ICU. His blood pressure was 60~70/40~50mmHg, and his heart rate was 82bpm, which put his life in a critical condition.

Dong’s team established an extracorporeal circulatory support system by using percutaneous approach. The circuit was configured with left atrial cannulation via jugular venous cannulation as an inflow, and axillary artery cannulation with a side graft as an outflow. The procedure went well. It was minimally invasive to the upper body and therefore did not affect the movement of the lower limbs. Due to the effective extracorporeal circulatory support, the patient’s circulatory status had been significantly improved as well. The patient eventually got his matching donor heart on the twelfth day after the operation.

NyokAssist^™ percutaneous VAD strives to meet clinical needs and improve survival chances for high-risk patients in percutaneous coronary intervention (PCI) cases. This product is small and can be implanted in the patient’s body with minimal invasion. It is delivered through the femoral artery and then along the aorta into the ventricle. Percutaneous VAD pump, composed of polymers and shaped memory alloy, can be folded like an umbrella and unfolded inside the heart, increasing safety and patient compliance. The pump perfectly balances its smaller size and powerful bloodpumping capabilities.

The way technology can fulfill the clinical needs is what creates value

magAssist’s latest generation BreathMoAssist^™ ECMO is ideal for all emergency scenarios. Adding a self-designed oxygenator on top of MoyoAssist^® ExtraVAD, the new generation ECMO is expanding its repertoire to cardiopulmonary circulatory support.

“The successful development of the MoyoAssist^® maglev pump has improved hemocompatibility to the entire ECMO system, which differentiates magAssist from competitors,” states Dr. Hsu.

The ECMO product is currently in preclinical development. magAssist has made its system more portable by adding a frame and a place for the oxygenator and pump to sit. This feature can be added to its console controller and combined with a bed or trolley. BreathMoAssist’s lightweight and portable design makes it the perfect choice for reliable ECMO in various settings, including ambulatory automobiles and emergency rooms.

magAssist has developed DonorLife^™ Organ Care System Donor to solve the clinical pain points of transferring donor organs over long distances and can transport organs under the supply of oxygenated blood.

The system reduces the degree of organ damage significantly while the preservation time is expected to exceed 12 hours and achieve full coverage of domestic transportation, expanding the geography of organ donors.

magAssist has many success stories of providing clinical assistance to patients with its agile and robust maglev technology.

Apart from previous mentioned case, magAssist’s product helped a 31-yearold woman with end-stage heart failure that required a transplant. It took long in China to find a donor’s heart that would suit her blood type, and her health worsened to the extent that even coughing could lead to cardiogenic shock and heart defibrillation. Her medical team opted to place her on MoyoAssist^® ExtraVAD to get additional time as they awaited a donor’s heart. While on Extra-VAD, the maglev blood pump worked in place of her heart and ensured all her organs received oxygenated blood.

Her condition soon stabilized, although she had to be monitored in the ICU. Ten hours after being on the Extra VAD, she was awake and extubated by doctors. After twelve days in ICU, the patient received a donor’s heart, and eventually, she resumed her normal life.

magAssist transforms cuttingedge technology into effective medical treatments for patients. Starting with maglev artificial heart technology, it aims to develop platform-based solutions for extracorporeal life support systems, filling the unmet needs of different clinical scenarios, and serving cardiovascular patients worldwide. In the realm of extracorporeal life support systems, magAssist possesses the most powerful technology, a complete product line, and the fastest research and development advancement. It is also worth knowing that MoyoAssist^® Extra-VAD bagged Australian Good Design Award Winner 2022 and also became a Finalist for Victorian Premier’s Design Awards 2022.

Indeed, magAssist has come a long way in its journey as a trailblazer of medical devices in China. Its remarkable achievements in the field are just the beginning of unfolding a whole new world of opportunities in the medical industry.