Xvivo Perfusion AB (publ) announced that at the 2024 International Society of Heart and Lung Transplantation meeting in Prague, Czech Republic, the results from XVIVO's clinical trial, NIHP2019, in heart transplantation were presented. The results showed that the primary endpoint, representing severe complications after heart transplantation, was registered in 18.8% of the subjects who received a donor heart preserved with the XVIVO Heart Assist Transport and in 30.1% of subjects in the control group who received a donor heart transported on ice, the current gold standard. The rates of severe primary graft dysfunction (PGD) after heart transplantation were also lower for patients who received a donor heart preserved with the XVIVO Heart Assist Transport (11% compared to 28%).

The NIHP2019 trial is a randomized, controlled, open label, multicenter clinical investigation of the XVIVO Heart Assist Transport to collect the safety and performance data to support CE marking. The NIHP2019 trial enrolled 203 patients in 15 institutions across 8 European countries between November 2020 and May 2023. In the US, XVIVO has obtained Investigational Device Exemption (IDE) approval by FDA for a heart preservation trial (PRESERVE) to collect the safety and effectiveness data required to support future PMA applications.

Recruitment in the PRESERVE trial is ongoing.