Bridge to Life Wins FDA Nod for First U.S. Cold Machine Perfusion System for Liver Transplants
Event summary
- FDA granted De Novo clearance to Bridge to Life's VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System on January 20, 2026
- First U.S. approval for cold machine perfusion in liver transplant preservation
- Clearance covers both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donors
- Bridge to HOPE clinical trial enrolled 219 recipients across 15 U.S. transplant centers
- Commercial launch expected in Q1 2026
The big picture
This FDA clearance establishes a new regulatory classification for hypothermic oxygenated perfusion in liver transplantation, positioning Bridge to Life as a leader in advanced organ preservation. The approval comes at a time when transplant programs are increasingly focused on optimizing preservation strategies, particularly for DCD grafts, which represent a growing donor category. The system's design, which allows for flexible perfusion duration, addresses key operational challenges in transplantation logistics.
What we're watching
- Adoption Pace
- How quickly U.S. transplant centers will integrate VitaSmart into clinical practice, given its FDA-cleared status and broad applicability.
- Economic Impact
- Whether the system's capital-efficient design will drive cost savings for transplant programs and improve organ utilization rates.
- Competitive Response
- How existing and emerging competitors in organ preservation technology will react to Bridge to Life's first-mover advantage in the U.S.
Related topics