Bridge to Life, an innovator in organ preservation and perfusion technologies, has received De Novo clearance from the US Food and Drug Administration (FDA) for its VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System, establishing a new regulatory classification for liver perfusion in the United States.

The FDA clearance enables the commercial use of VitaSmart for hypothermic oxygenated perfusion of donor livers following static cold storage and prior to transplantation. This approval provides US transplant centres with a clearly defined, regulated pathway to integrate HOPE protocols into routine clinical practice.

Don Webber, CEO and President of Bridge to Life, said, “This clearance represents a transformational milestone for Bridge to Life and an important advancement for liver transplantation in the United States. VitaSmart is the first FDA-cleared hypothermic oxygenated perfusion system for liver transplantation.”

The FDA-cleared indication supports hypothermic oxygenated perfusion for donor livers from both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donors within defined donor criteria. Notably, the clearance does not specify a maximum perfusion duration, allowing clinicians flexibility to apply HOPE using clinical judgment and established protocols.

Dr. Kristopher Croome, Professor of Surgery and Transplant and Hepatobiliary Surgeon at Mayo Clinic Florida, commented, “Having a FDA-cleared hypothermic oxygenated perfusion system commercially available is a significant development for transplant programmes. The availability of VitaSmart’s HOPE technology supports ongoing efforts to optimise preservation strategies, particularly for DCD liver grafts.”

Within the scope of the cleared labelling, VitaSmart is designed to integrate seamlessly into existing transplant workflows, offering flexibility in preservation strategies and enabling a centre-friendly, non-transport-based, back-to-base approach to hypothermic oxygenated perfusion. These attributes position the system as a scalable and economically compelling platform for broad adoption across US transplant centres.

FDA clearance was supported by data from the Bridge to HOPE pivotal clinical trial, a multicentre, randomised controlled study conducted across 15 US transplant centres. The study enrolled 219 adult liver transplant recipients, including extended-criteria donor populations from both DBD and DCD grafts. Trial results demonstrated statistically significant improvements in early graft function alongside a strong safety profile, forming the basis for the FDA’s De Novo determination.

From an operational and economic standpoint, VitaSmart is designed to support improved organ utilisation, reduced downstream resource use, simplified workflow integration and a capital-efficient approach to advanced organ preservation. These factors are increasingly important as transplant programmes balance clinical outcomes with operational complexity and resource constraints.