The ENHANCE trial is a two-part program enrolling over 650 donors to evaluate prolonged heart perfusion with the OCS Heart system in part A and compare clinical outcomes against traditional static cold storage in part B. TransMedics received full, unconditional FDA IDE approval for its next-generation OCS ENHANCE Heart trial, removing a key regulatory milestone and authorizing patient recruitment and full trial execution. This approval de-risks TransMedics’ clinical roadmap, supports potential label expansion and broader adoption of the OCS platform, and could drive recurring disposables revenue by extending preservation windows and increasing utilization per transplant center.