XVIVO: FDA gives a green light to include DCD hearts in the pivotal US study - Redeye

We expect XVIVO to initiate the US study during early Q4 2023 and the inclusion of donation after circulatory death (DCD) hearts is very positive in our view. The FDA clarification comes early and it opens for a future label including DCD hearts including securing clinical experience among some 20 leading US centers early on.

Länk till analysen i sin helhet: https://www.redeye.se/research/926172/xvivo-fda-gives-a-green-light-to-include-dcd-hearts-in-the-pivotal-us-study?utm_source=finwire&utm_medium=RSS