Cologne / Aachen – August 25, 2026 – Vivalyx, an organ vitality tech company developing the next generation of organ preservation solutions, has been formally granted Breakthrough Medical Devices Status by the European Medicines Agency (EMA) under its newly launched program for Vivalyx’s organ preservation solution Omnisol. Omnisol was selected together with four other devices.
Vivalyx’s product, Omnisol, is a patented, blood-free organ preservation solution designed to work across all organ types and all preservation methods – including Static Cold Storage (SCS), Hypothermic Oxygenated Machine Perfusion (HOPE), and Normothermic Machine Perfusion (NMP). The primary focus is on kidney and liver. With over one million patients currently on organ transplant waiting lists worldwide, Omnisol aims to address a critical unmet medical need.
The EMA pilot, launched in April 2026, provides enhanced regulatory support and priority scientific advice from the medical device expert panels overseen by EMA for devices granted ‚breakthrough‘ status. The breakthrough status reflects recognition of Omnisol’s potential to offer substantial advantages over existing technologies.
„We are thrilled that Omnisol has been granted breakthrough status under this important EMA program. We believe Omnisol has the potential to fundamentally change organ preservation and, ultimately, improve outcomes for transplant patients across Europe and beyond.“ – Andreas Schumacher, CEO, Vivalyx
The company previously secured a €2.5 million grant from the European Innovation Council (EIC) Accelerator in February 2025, underscoring the broader recognition of its technological approach within the EU.
While the Breakthrough Device designation is awarded through the EMA program, Vivalyx is also progressing through the conformity assessment process with BSI as its Notified Body. As one of the first companies navigating this new regulatory pathway, Vivalyx has benefited from BSI’s deep regulatory expertise and collaborative approach. This has supported the efficient advancement of Omnisol toward commercialization while maintaining a strong focus on quality, safety, and compliance with EU regulatory requirements.
About Vivalyx
Vivalyx GmbH was founded in 2022 in Aachen by Dr. Andreas Schumacher, Dr. Benedict Doorschodt, Prof. Dr. René Tolba, PD Dr. Christian Bleilevens, Prof. Dr. Malte Brettel, and Marius Rosenberg. The medtech startup has developed an innovative technology for revitalizing donor organs with the goal of enhancing their vitality and thus increasing the number of available organs for life-saving transplants. The Vivalyx team combines medical, medtech, regulatory, and entrepreneurial expertise and has already attracted notable investors. For more information, visit: www.vivalyx.com
Forward-Looking Statements
Statements in this release about the future development and potential of Vivalyx Omnisol® reflect current expectations and involve risks that could cause actual results to differ. In the indication described in this press release, Vivalyx Omnisol® is investigational and not approved for commercial use.
