Vivalyx announces First-in-Human use of Vivalyx Omnisol® in kidney transplant clinical trial marking the company’s transition to clinical stage
Rotterdam / Cologne – March 17, 2026 – Organ-vitality-tech company Vivalyx today announced that the first patients have received donated kidneys that were machine-perfused using Vivalyx Omnisol®, the company’s novel organ perfusion preservation solution. This milestone represents Vivalyx’s first-in-human clinical trial experience. It marks a significant step in the company’s mission to improve organ preservation and increase the number of organs available for transplantation.
The kidney transplants were performed as part of a clinical trial at Erasmus Medical Center in Rotterdam, The Netherlands. In this study, Vivalyx Omnisol® is being evaluated as an alternative to the preservation solution that has been in clinical use for several decades and is considered standard of care for kidney machine perfusion.
“We extend our deepest gratitude to organ donors and their families, as well as to the transplant recipients and the entire transplant team for their trust - without them, transplantation and progress in transplant medicine would not be possible. The fact that patients have now received kidneys perfused with Vivalyx Omnisol® is a first‑in‑human milestone built on years of scientific work and close collaboration with the transplant community. It marks our transition from the preclinical to the clinical stage and is an important first step toward our vision of increasing the number of organs available for transplantation”
The clinical trial is being led by Principal Investigator Dr. Robert Minnee at Erasmus MC Rotterdam.
“As transplant surgeons and researchers, our responsibility is to continually evaluate innovations that may advance the field. We are genuinely encouraged by the initial observations in this study and by how seamlessly the product integrates into the clinical protocol. That is precisely why we participate in clinical research - to rigorously assess new approaches that have the potential to meaningfully contribute to transplantation medicine, always with patient safety and scientific integrity as our highest priorities.”
Vivalyx’s long-term vision is to contribute to expanding the availability of transplantable organs. By advancing preservation science and supporting the transplant ecosystem, the company aims to help more patients gain access to life-saving transplantation.
Vivalyx Omnisol® is an investigational product and is currently being evaluated in clinical research. It has not been approved by the U.S. Food and Drug Administration (FDA), has not received CE marking under the EU Medical Device Regulation (EU MDR), and is not yet commercially available.
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 organ vitality technology startup has developed an innovative technology to revitalize donor organs with the goal of enhancing their viability and increasing the number of available organs for life-saving transplants. The Vivalyx team combines expertise in medicine, medical technology, regulatory affairs, and entrepreneurship and has already attracted prominent investors.
