Hannuo Medical's Lifemotion ECMO Gains International Recognition as China Offers Solution to Global Supply Shortage

“The ECLS (Extracorporeal Life Support) industry is facing unprecedented supply shortages.” This statement was made by Professor Heidi Dalton, a representative of the organizers, during the panel discussion on “Addressing Challenges in ECLS Equipment, Consumables, and Supply Chains” at the recent annual conference of ELSO, the most authoritative global organization in the field of extracorporeal life support, held in Seattle, USA.

“The industry landscape of extracorporeal life support (ECLS) is evolving rapidly, with more devices and disposable consumables available on the market than ever before.”

Why Do Two Seemingly Contradictory Phenomena Coexist in the Current ECLS Market?

What Exactly Is Causing the Paradox of Rapid Development Coupled with Supply Shortages in Extracorporeal Life Support, Particularly for Global ECMO Devices and Consumables?

To trace the roots, we must start with the rapid growth in demand.

Undoubtedly, over the past three years, influenced by sudden public health emergencies, global perceptions of ECMO technology have been revolutionized, and greater emphasis has been placed on its application in critical care units.Within China alone, the “Notice on the Work Plan for Medical Resource Preparedness” issued in 2023 by the Comprehensive Group of the State Council’s Joint Prevention and Control Mechanism stipulated that each set of 10 comprehensive ICU beds in hospitals should be equipped with one ECMO device. Based on an estimated 130,000 ICU beds in tertiary hospitals, approximately 13,000 ECMO devices would be required, whereas the current installed base of ECMO devices in the domestic market stands at only around 2,000 units.

“Expert Consensus” is also further promoting the industry’s understanding and use of ECMO devices. Graphic by VCBeat

As an indispensable device for patient treatment, expert consensus and policy releases have further promoted the construction of ECMO centers in China and the growth in the number of cases. Data from CSECLS shows that by the end of 2022, there were a total of 676 ECMO centers in China, with 13,491 ECMO procedures performed. Currently, the number of ECMO procedures is still growing rapidly.

Source: Chinese Medical Doctor Association Extracorporeal Life Support Professional Committee, "2022 China ECMO Survey Report"

In fact, demand for ECMO equipment has long been growing rapidly due to the multidimensional expansion of its application scenarios—

ECMO technology is an essential technology for circulatory and respiratory support., such as perioperative protection in cardiac surgery, fulminant myocarditis, perioperative protection in percutaneous coronary intervention (PCI), bridge therapy for severe heart failure or cardiogenic shock, acute respiratory distress syndrome, and severe pneumonia. These conditions represent its application scenarios, with a large patient population globally.

Taking perioperative protection during PCI as an example, the procedure is prone to complications such as cardiogenic shock, acute heart failure, malignant arrhythmias, and even cardiac arrest, necessitating ECMO intervention to improve surgical success rates and patient prognosis. ECMO can provide circulatory support for approximately 10%–30% of high-risk PCI procedures. According to Frost & Sullivan data, the number of PCI procedures in Europe increased from 890,000 in 2015 to 1.4 million in 2021, while in the United States, the volume grew from 592,700 in 2015 to 1 million in 2021. Relevant data indicate that the number of PCI procedures performed in mainland China reached 1,293,932 in 2022, representing a year-on-year increase of 11.15%.

Image source: CCIF & CCPCC 2023 Conference, 2022 Registry Data on Percutaneous Coronary Intervention in Mainland China

Furthermore, ECMO’s clinical applications have gradually expanded to include areas such as combined therapy for multi-organ failure, donor organ protection in transplantation, supportive care during the transitional period of heart-lung transplantation, adjunctive support for airway surgery, and treatment of smoke inhalation injury., and the market in related fields holds immense growth potential. Taking the treatment of chronic obstructive pulmonary disease (COPD) as an example, Frost & Sullivan data projects that there will be nearly 300 million COPD patients worldwide by 2030. Currently, China has over 100 million COPD patients. In the treatment of COPD, it is necessary to clear high concentrations of carbon dioxide retained in the blood, which requires support from ECMO equipment.

Source: Frost & Sullivan

ECMO, as an indispensable device in the treatment of the aforementioned diseases, is experiencing rapid growth in demand.

However, as demand surged rapidly, the supply of ECMO equipment and consumables encountered problems.

The trigger occurred in March this year—Maquet voluntarily recalled the QUADROX-iD Pediatric Oxygenator after discovering during a review of non-conformance reports that the sterile barrier of the membrane oxygenator might have been compromised and that there could be deviations in the product coating.As the world’s largest ECMO manufacturer by market share, its voluntary recall of ECMO products has directly disrupted the global ECMO supply chain, widened the supply gap, extended lead times, and resulted in supply shortages.

This recall does not involve the Chinese market. However, in China, manufacturers of ECMO devices and consumables, such as Maquet and Medtronic, have long dominated the market. As Maquet became embroiled in the recall controversy, its supply lead times extended. Meanwhile, following a Class I recall of its ECMO centrifugal pump blood control monitoring system in 2022, Medtronic has, according to media reports, largely phased out sales of its main ECMO equipment in China, focusing primarily on consumables. Furthermore, since ECMO systems are complex extracorporeal life support systems integrating multiple disciplines such as hemodynamics and bionics, ECMO devices and consumables are often sold as proprietary, device-specific pairs. For instance, ECMO devices manufactured by Maquet must be used with consumable kits from the same manufacturer. This has further exacerbated the shortage of ECMO devices and consumables in China.

How can we address the issues arising from the global imbalance in the supply of ECMO devices and consumables under such circumstances?

To explore optimal solutions for addressing the shortage of ECMO devices and consumables, a special forum titled “Addressing ECLS Device and Consumable Supply Chain Challenges” was convened at the 34th ELSO Annual Meeting. The forum invited experts and corporate representatives from around the world. Notably, the conference also invited a Chinese company—Lifemotion—which was the only Chinese enterprise participating in this year’s ELSO meeting.

The reason is also obvious.Following the United States, Germany, and Italy, China has become the fourth country in the world capable of independently producing ECMO systems.Since January this year, ECMO devices in China have been successively approved. After Lifemotion obtained the first certification for ECMO consoles and associated consumables in January 2023, Changzheng Medical and Saitong Medical also sequentially received medical device registration certificates for their ECMO consoles. Notably, in July of this year, Lifemotion’s single-centrifugal pump head and single-membrane oxygenator were successfully approved, meaning that Lifemotion’s first-generation ECMO product line has now secured four Class III medical device registration certificates for domestically produced devices.This also makes it the domestic company in China with the most comprehensive core ECMO product line, encompassing both active and passive components.

Lifemotion’s comprehensive product portfolio and its domestically recognized product strength brought the company into the spotlight for the conference organizers. At the event, Lifemotion lived up to the expectations of the organizers, as well as global ECMO researchers and medical professionals. During this premier academic exchange in the field of extracorporeal life support worldwide, Lifemotion, together with multiple clinical experts from renowned Chinese hospitals, presented its latest clinical research findings on ECMO, with four abstracts selected for ELSO 2023. This achievement signifies that Lifemotion and the Chinese ECMO devices it represents have gained recognition from an authoritative international society.

Specifically, the results of two studies demonstrated the safety and efficacy of Lifemotion’s ECMO devices.

For example, the study “Preliminary Evaluation of the Safety and Performance of a Novel Extracorporeal Membrane Oxygenation Device in a Chronic Sheep Model,” conducted by the Guangdong Provincial Institute for Laboratory Animal Monitoring, demonstrated the safety and reliability of the Lifemotion ECMO system based on animal clinical data. Furthermore, the multi-institutional collaborative study “Safety and Efficacy of the Lifemotion ECMO System in Long-Term Cardiopulmonary Support in Adults” explicitly stated that Lifemotion’s ECMO devices can provide satisfactory oxygenation and hemodynamic status for patients with severe cardiopulmonary dysfunction, thereby improving their survival rates and quality of life.

A review of the Maquet ECMO recall reveals that the core issue lies in product performance and, fundamentally, manufacturing quality. Enhancing product performance and production quality is, in the long run, the optimal solution to address the global shortage of ECMO supplies. At this conference, Lifemotion has presented a Chinese solution to this challenge.

Moreover, two additional studies presented by Lifemotion at the conference revealed new trends in the development and clinical application of ECMO devices.

The “Comparative Evaluation of ECMO Systems and Their Characteristics” conducted by the Guangdong Provincial Engineering Technology Innovation Center for Organ Support compared various ECMO products on the market, highlighting that a major development trend in ECMO devices is greater portability, longer battery life, and extended operational duration, as exemplified by the Lifemotion ECMO.

In terms of weight, battery life, usage duration, and membrane surface area, Lifemotion possesses unique advantages. Image source: “A Comparative Review of ECMO Systems and Their Features,” ASAIO Journal

The study titled “Clinical Outcomes of High-Risk Percutaneous Coronary Intervention (HR-PCI) in Patients Supported by Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO),” conducted by the First Medical Center of the Chinese People’s Liberation Army General Hospital, provides clinical evidence to expand treatment options for high-risk PCI patients. It indicates that VA-ECMO-supported HR-PCI can effectively improve cardiac function and prognosis in patients with complex coronary artery disease who are not candidates for surgical revascularization.

This also sends a clear signal to the outside world: Chinese companies, in the field of high-end medical equipment including ECMO devices, are no longer merely following in the footsteps of international giants but are already capable of contributing their own strength to industry development.

Indeed, China’s high-end medical equipment sector has long grappled with critical technological bottlenecks and import monopolies. For instance, in the field of extracorporeal life support, where Lifemotion operates, the market has been dominated for years by major foreign manufacturers such as Maquet, Medtronic, and LivaNova.

Faced with differences in clinical usage habits between domestic and international physicians, as well as the high cost of imported equipment, clinicians in China are also eagerly anticipating the rise of domestic manufacturers.

In this context, the state has successively issued various policies. Documents such as the "14th Five-Year Plan for the Development of the Medical Equipment Industry," the "Implementation Plan for the Construction of a High-Quality and Efficient Medical and Health Service System during the 14th Five-Year Plan Period," and the "Outline of the 14th Five-Year Plan for National Economic and Social Development of the People's Republic of China and Long-Range Objectives Through the Year 2035," released by institutions including the National Development and Reform Commission and the National Health Commission, proposeOpinions on concentrating resources to enhance the core competitiveness of high-end medical equipment and promoting innovative development in the medical device industry explicitly call for strengthening the deployment of devices such as Extracorporeal Membrane Oxygenation (ECMO) in healthcare institutions and achieving breakthroughs in the core technologies of high-end medical equipment like ECMO.

IncludingThe achievements made by domestic brands of high-end medical equipment, including Lifemotion, have been cultivated in such a fertile policy environment., they gradually took root and sprouted, ultimately blossoming and bearing fruit: with the successive approvals of ECMO systems from manufacturers such as Lifemotion, China has become the fourth country in the world capable of independently producing ECMO equipment systems.

Furthermore, driven by continuous policy support and the vigorous efforts of enterprises, a cohort of domestic companies that have achieved phased milestones is not only capable of addressing challenges in the Chinese market but has also embarked on globalization. These companies are gradually accumulating influence in the global market with the aim of ultimately leading industry development.

For example,As the company with the most comprehensive ECMO product portfolio in China, Lifemotion is reported to have fully launched its “going global” development strategy after obtaining NMPA registration certificates this year., further accelerating international registration and certification to expedite the overseas launch of products, and continuously expanding into overseas markets to refine the construction of a global marketing and service ecosystem. Other domestic ECMO device manufacturers are also accelerating their expansion into overseas markets.

Amid the current global shortage of ECMO devices and consumables, we have reason to believe that, with the concerted support of multiple stakeholders, domestic Chinese ECMO manufacturers are well-positioned to help address the challenges facing the global industry. It is undeniable that Chinese enterprises will secure their place in the future high-end medical equipment market, and innovative Chinese forces represented by Lifemotion are poised to step onto the world stage.