According to Duluth, Georgia–based Bridge to Life, the FDA clearance enables the commercial use of VitaSmart for hypothermic oxygenated perfusion of donor livers following static cold storage and prior to transplantation. The De Novo clearance enables a clear, regulated pathway for U.S. transplant centers to incorporate HOPE protocols into clinical practice.

The clearance was supported by results from a study that enrolled 219 recipients across 15 U.S. transplant centers. Bridge to Life plans a U.S. commercial launch of VitaSmart during the first quarter of 2026.