Vivalyx Omnisol® is among the first five devices to be granted Breakthrough Medical Devices Status by the European Medicines Agency (EMA) under its new breakthrough devices programme. For BVP portfolio company Vivalyx, the designation confirms both the degree of innovation behind Omnisol and the unmet medical need it addresses.
The EMA launched the programme in April 2026 to support highly innovative medical devices with the potential to address unmet medical needs or deliver significant clinical benefit compared with existing alternatives. Devices granted the status receive enhanced regulatory support and priority scientific advice from the EMA’s medical device expert panels as they advance toward conformity assessment and commercialization. Selection in the first cohort places Omnisol in a small group of technologies the EMA considers most consequential for European patients.
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), with an initial focus on kidney and liver. Today, transplant clinics rely on preservation solutions developed decades ago, while more than one million patients worldwide remain on transplant waiting lists. By improving organ vitality during preservation, Omnisol aims to increase both the quality and the number of organs available for transplantation.
The designation follows a period of consistent execution by the Vivalyx team. In March 2026, the company announced the first-in-human use of Omnisol in a kidney transplant clinical trial at Erasmus Medical Center in Rotterdam. Vivalyx is also backed by the EIC Accelerator with up to EUR 8.5 million to advance its organ revitalization technology.
“Breakthrough status is scarce. The EMA selected a handful of devices from across Europe. Omnisol is one of them, being a single solution that works across organs and preservation methods to address a structural constraint in transplant medicine. We look forward to seeing it reach the patients waiting for a transplant.”
About Vivalyx
Vivalyx is an organ-vitality-tech company founded in 2022 in Aachen, Germany. The company develops technologies that increase the vitality and number of donor organs available for transplantation. Vivalyx is a portfolio company of Brightlands Venture Partners.
Vivalyx Omnisol® is investigational and not approved for commercial use.
