Marking the company’s transition to clinical stage
Rotterdam / Cologne – March 16, 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,” said Dr. Benedict Doorschodt, CTO and Co‑Founder of Vivalyx.
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,” said Dr. Robert Minnee. “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 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
This press release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, statements regarding the potential benefits, safety, performance, regulatory pathway, and future development of Vivalyx Omnisol®, as well as the company’s vision to increase the number of organs available for transplantation. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Factors that may cause such differences include, but are not limited to, clinical trial outcomes, regulatory review and approval processes, manufacturing considerations, and other risks inherent in the development of investigational medical products. Vivalyx undertakes no obligation to update forward-looking statements except as required by law.
Caption: First-in-Human Use of Vivalyx Omnisol® in Kidney Transplant Clinical Trial
