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LifeShield Medical — Aachen and China

More details? Here we go, chronologically.

2011
Founding enmodes

Aachen, Germany

Dr. Tim Kaufmann and Prof. Dr. Ulrich Steinseifer met at RWTH Aachen University and eventually founded enmodes, building on deep expertise in computational fluid dynamics (CFD) and cardiovascular engineering. The vision: translate that knowledge into real medical devices, as an independent R&D and design partner to the industry.

2012
Innovation / Milestone #1

enmodes grows — and quickly. The company soon builds a reputation as a service provider for cutting-edge blueprints, establishing itself as a trusted partner for cardiopulmonary solutions and earning contracts with leading multinational medical device companies.

2015
Innovation #2

The initial in-house research work begins under Dr. Ralf Borchardt, expanding enmodes from pure design services into own R&D on blood pumps and membrane oxygenators.

2017
Recognition

enmodes is ranked the #1 medical device start-up in Europe by the European Institute for Innovation and Technology (EIT) — affirming the team's position at the leading edge of cardiopulmonary innovation.

EIT Health — enmodes ranked #1 medical device start-up in Europe 2017
2017
Team Expansion

In November 2017, as the company grows, so does the need for manpower across a wide range of business functions. Sascha Kuns joins the team as CFO, bringing years of experience to cover the business side of the company — with a focus on further expansion and growth plans.

2018
Road to China

Founding LungShield

After years of growing as a service provider, enmodes decides to take the step toward developing its own products — increasing impact and broadening scope. This leads them to Suzhou, China, where Christian Wischnewski takes charge of building the new business named LungShield, focused on extracorporeal life support and unmet clinical needs in cardiovascular care.

Lungshield Medical founding — Suzhou launch 2018
2020
Joint Venture

A Joint Venture with Proxima Ventures is formed. The funding it provides enables the company to onboard Michael Chen as CEO in China, bringing 20+ years of structural-heart and cardiovascular commercialization experience at multinational medical device companies to the Chinese market. The JV also brings Cindy Zhang on board as regulatory lead, charged with steering the product portfolio through Chinese and international approval pathways.

2021
Founding LifeShield

A unified Sino-German group

The ten years of experience built up at enmodes and LungShield are brought together in LifeShield — creating a product portfolio that addresses the lungs, the heart, and their interaction. The focus is exactly there — providing the best possible care to patients in need, with the aim to Save and Support Lives.

LifeShield Medical founding — Sino-German group launch 2021
2022
Product Pipeline

The pVAD program comes together as a joint German–Chinese venture. enmodes lays the scientific and engineering groundwork in Aachen; the Chinese team then takes the baton, refining the device through successive design iterations to ready it for market and regulatory testing. The focus: supporting patients through high-risk PCI procedures and in cardiogenic shock — areas of profound unmet clinical need.

2023
Quality Milestone

Lungshield Medical passes its first ISO 13485:2016 audit by TÜV SÜD — an internationally recognized quality management framework for medical device manufacturers — laying the foundation for global market readiness.

Lungshield Medical ISO 13485 TÜV SÜD quality milestone
2025
Commercialization

Rengine® ECMO system approved

The Rengine® ECMO system receives NMPA commercial approval in China — the console in June 2025, followed by the oxygenator set in July. The oxygenator set is China's first approved for 8-day long-duration use, featuring a layered-membrane design, a low-shear pump head, and a specialized coating that reduces clotting and extends device lifetime.

Rengine® ECMO system — NMPA commercial approval 2025
2025
Global HQ

In November 2025, LifeShield's new Global Headquarters is established in Beijing, anchoring executive leadership and strategic direction as the company enters its next phase of growth.

2025
Manufacturing

In December 2025, LifeShield commissions a specialized cleanroom facility in Hangzhou dedicated to cannula production. It joins the company's existing class-10,000 cleanroom manufacturing facilities at LifeShield Medical Suzhou and Lungshield Medical — expanding capacity across the portfolio under a dedicated manufacturing team.

2026
Going International

Hong Kong MDACS registration

The Rengine® ECMO system — oxygenator set and console — is registered on the Hong Kong Department of Health medical device listing (MDACS), LifeShield's first international regulatory approval beyond mainland China. A step forward in the mission to Save and Support Lives worldwide.

2026
Coming Up

LifeShield presents its portfolio at MEDICA 2026 in Düsseldorf (November 16–19), the world's leading medical trade fair.

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