LifeShield Medical Establishes China Headquarters in Suzhou, Accelerating Development of Three Core Life Support Product Lines

On the afternoon of January 18,LifeShield Medical China Headquarters and LifeShield Interventional Artificial Heart System Factory Officially Open in Suzhou Industrial ParkRepresentatives from various parties attended this event, including Liu Hua, member of the Party Working Committee and Deputy Director of the Management Committee of Suzhou Industrial Park; Cao Guofen, Deputy Director of Suzhou Municipal Bureau of Commerce; Chen Zulin, CEO of LifeShield Medical; Professor Ulrich Steinseifer, co-founder of LifeShield Medical; and Dr. Tim Kaufmann, Chairman of LifeShield Medical.

LifeShield Medical Group is a Sino-German multinational medical device company dedicated to the research, development, and production of innovative medical devices in the field of advanced international extracorporeal and intracorporeal life support technologies. Backed by an international professional team and deep technical expertise along with extensive experience in product transformation, the company’s three core innovative products—pVAD, an extracorporeal carbon dioxide removal system, and an ECMO system—are all progressing rapidly. The first two products are expected to fill a market gap in China, while the latter is anticipated to provide clinically superior innovative solutions.

As an international enterprise, the establishment of LifeShield Medical's headquarters in China represents a significant commitment to the continuously growing Chinese medical device market. The company’s future development will be rooted in China while facing the global market. Meanwhile, the headquarters in Suzhou Industrial Park, supported by the local government, will leverage the park’s integrated industrial ecosystem that combines talent, capital, technology, and platforms, effectively utilizing various resources. For instance, the park’s policy-driven investment platform will support LifeShield Medical’s growth through equity investment.

LifeShield Medical's China headquarters houses a research and development center, production base, and office building. It is responsible for the development of core technologies and production processes and serves as a global production base for the autonomous mass production of products. The China headquarters will collaborate with its subsidiary, LungShield Medical, and Germany's enmodes company to fully leverage team capabilities, break through innovative technologies, and, based on local clinical needs in China, advance three core product pipelines.

Professor Ulrich Steinseifer, who attended this event, is the co-founder and chief scientist of LifeShield Medical. He currently serves as the director of the Institute of Cardiovascular Engineering at RWTH Aachen University in Germany and the president of the European Society for Artificial Organs, and has previously served as the president of the International Society for Mechanical Circulatory Support. As an academic leader in the cardiovascular field, Professor Ulrich Steinseifer has led his team in the deep cultivation of cardiovascular device development and technological breakthroughs, fostering innovation that has nurtured team members. These efforts have subsequently led to the advancement of multiple internationally leading medical device projects.

And as a "gardener,"Professor Ulrich Steinseifer has extensive technical expertise and industrialization experience, holding 133 international patents. He has led over 20 innovative medical device projects and successfully advanced them to the industrialization stage, including the world's first interventional artificial heart, "impella.". It was born in Professor Ulrich Steinseifer's institute in 1990, and later moved out of the institute into industrialization and commercialization, successfully supporting Abiomed's billion-dollar market value.

Based on years of technical accumulation and driven by clinical needs in China, LifeShield Medical's pVAD product features an original design. It consists of a portable main unit and an interventional catheter pump, whereThe interventional catheter pump adopts a micro high-speed impeller to achieve high fluid performance, high efficiency, and low hemolysis. It also uses an original non-potted motor sealing technology to assemble the micro motor, which can avoid the risk of liquid leakage brought by the existing perfusion cleaning fluid sealing catheter pump technology and effectively bypass the patent barriers of market leaders.。

Previously, LifeShield Medical's pVAD successfully completed chronic animal experiments. The results showed that the interventional operation was convenient and safe, the interventional catheter pump achieved long-term reliable operation, the hemolysis value was far below the clinical threshold, and there were no significant complications. The safety and effectiveness of the product have been verified, and type inspection will be carried out soon.

The factory area of LifeShield Medical's interventional artificial heart system, which opened at the same time, covers a total of 2,500 square meters. Among this, the cleanroom facility was constructed according to ISO13485 (international standards) and Class 10,000 GMP standards, laying a solid foundation for the independent production and export of products. As the global production base for LifeShield Medical's new generation of interventional artificial heart systems,It has the capacity to produce 5,000 sets of interventional cardiac pumps and 300 units of interventional cardiac device mainframes annually.。

Interventional catheter pumps are Class III active consumables, containing core components such as micro motors, sensors, and high-speed rotating impellers. They have high-quality requirements and are difficult to manufacture. There are currently no manufacturers in China that produce medical-grade micro motors, so device companies rely on imports, with production remaining at the whole machine assembly level.

And Lifeshield Medical's interventional artificial heart system factory can purchase raw materials,Production of medical-grade micro motors, achieving component-level production and assembly, further strengthening independent production capabilities.. In this way, it not only enhances the autonomy of production and manufacturing, strengthens the stability of the supply chain, but also makes it convenient for enterprises to adjust the design of components according to demand.

LifeShield Medical mentioned: "The external environment has many uncertainties. By achieving self-production of core components, we have more options in raw material selection, avoiding production delays caused by limited parts supply, while ensuring the biocompatibility of core components complies with the regulatory requirements of China and the EU."

From the perspective of increasingly fierce competition in the medical device market and uncontrollable international environments, in recent years, medical device companies have been moving upstream. National policies also encourage breaking through the limitations of raw materials and core components, and companies that gain production autonomy will possess greater competitiveness.

While the new generation pVAD system is developing rapidly, LifeShield's ECMO system and extracorporeal carbon dioxide removal system have also made breakthrough progress.

Against the backdrop of the rapid development of emergency medicine and the increasing demand for clinical emergency care in China, LifeShield Medical has launched an innovatively designed ECMO system. It consists of a portable main unit and a stacked membrane oxygenator kit. The oxygenator adopts a stacked membrane design, which can ensure long-term operation while avoiding hemolysis. After testing,The oxygen transfer rate, carbon dioxide removal rate, and transmembrane pressure difference of the company's ECMO system are all higher than the industry gold standard., and the product is easy to operate, gaining high recognition in clinical settings.

Chronic animal experimental results showed that there was no significant thrombus formation after the oxygenator had been running for 30 days. Currently, the ECMO system is undergoing human clinical trials. The results of the most recent human trial case showed that after the ECMO oxygenator kit supported the patient for 22 days, postoperative examination revealed no significant thrombus inside the oxygenator and blood pump.The ECMO system is expected to complete human clinical trials and submit a registration application in the first half of this year.。

Targeting over 100 million COPD patients in China, LifeShield Medical has launched the first domestically produced extracorporeal carbon dioxide removal system. Its oxygenator also features an innovative stacked membrane design, minimizing blood clotting while achieving a carbon dioxide removal rate that reaches internationally leading levels. Additionally, the accompanying portable blood pump host is designed for ease of clinical use.

Currently,LifeShield Medical's extracorporeal carbon dioxide removal system has successfully completed type inspection and will soon commence human clinical trials at multiple respiratory intensive care centers in China (such as China-Japan Friendship Hospital, etc.)., bringing a new solution for severe COPD patients and filling the gap in extracorporeal carbon dioxide removal therapy in China.

At the beginning of the new year, LifeShield Medical has taken a crucial step. In the future, the company will be based in its China headquarters, with global branch centers working collaboratively to actively promote the certification, implementation, and international expansion of existing products, while developing more extracorporeal and intracorporeal life support devices. Building on its foundational technology platform, the company’s product pipeline has sustainable development advantages. Meanwhile,LifeShield Medical will gradually establish a commercial team and dealer channels in China starting this year., to push forward the commercialization process and achieve self-sufficiency as soon as possible.

Ulrich Steinseifer, Director of the Cardiovascular Research Institute at RWTH Aachen University and Chief Scientific Officer of LifeShield Medical"In the speech, it was expressed: 'Thanks to the close cooperation with the park, the LifeShield Medical China headquarters and new factory have successfully been completed in the park, marking that the team's research and development and production have entered an accelerated phase. The company will strive to transform globally leading technologies into products, promoting domestically innovative medical products with better efficacy and lower prices to the global market, benefiting more patients.'"

Jiang Weiming, Director of the Park Investment Promotion CommitteeRepresentative: "The selection of the Suzhou Industrial Park as the China headquarters location for LifeShield Medical, and the continuous expansion of its business footprint, fully demonstrates the company's strong capabilities and upward momentum. It reflects the senior management’s high level of trust in the investment environment of the park and stands as a powerful testament to the pragmatic cooperation and mutually beneficial partnership between China and Germany in the field of technological innovation. As Jiangsu Province’s first and only ‘Foreign Headquarters Economic Agglomeration Zone,’ the park has delivered impressive results that exceeded expectations in the development of an open economy. We welcome more Chinese and foreign enterprises to choose the park, invest in the park, introduce more high-end products and technologies into the park, and establish deep roots here. Together with the park, let us create an even brighter future."