XVIVO's innovative heart technology is currently under investigation in a randomized controlled clinical trial across 15 leading transplant centers in 8 European countries. 202 patients have gone through a transplantation in the trial which means inclusion is now completed of all planned participants. The next step is a one-year follow-up phase where patient outcome will be collected and monitored before the trial is closed and data presented.

However, the pre-work for initiation of the product approval process has already started and dependent on passing MDR (Medical Device Regulation) requirements, a CE mark can be expected in the first half of 2024. Developed in collaboration with Professor Stig Steen at Igelösa LifeScience in Sweden, the patented XVIVO heart device and proprietary solution are designed for preservation of donor hearts during transport using cold, non-ischemic perfusion. The European multicenter clinical trial is XVIVO's first heart preservation trial.

A US multicenter clinical trial is expected to start at the end of September.