#USA #FDA Approval #Duluth #VitaSmart™ #organ preservation

Bridge to Life Achieves Significant Milestone with FDA Approval for VitaSmart™

On January 20, 2026, Bridge to Life™ Ltd. announced a pivotal achievement in the field of organ transplantation — the U.S. Food and Drug Administration (FDA) granted De Novo clearance for its VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System. This remarkable device is the first of its kind to receive FDA approval for hypothermic oxygenation of donor livers in the United States, establishing a new standard for organ preservation and transplantation.

The FDA's endorsement of VitaSmart™ paves the way for its commercial application, specifically targeting the hypothermic oxygenated perfusion of donor livers after static cold storage and prior to transplantation. This approval provides a structured approach for transplant centers across the U.S. to integrate HOPE protocols into their clinical practices effectively.

A Transformative Solution for Liver Transplantation

"This clearance represents a landmark moment for Bridge to Life and a significant advancement in liver transplantation within the United States," remarked Don Webber, the CEO and President of Bridge to Life™ Ltd. He emphasized that VitaSmart™ not only stands as the first FDA-approved hypothermic oxygen perfusion system for liver transplants but also aligns with the FDA's conclusions regarding safety and effectiveness in real-world transplant scenarios. Webber believes this innovation will bolster organ utilization rates and offer substantial clinical and economic benefits to transplantation programs.

A notable aspect of the FDA clearance is the inclusion of donation after circulatory death (DCD) donors as part of its approved labeling. DCD donors are increasingly recognized as crucial to broadening the available donor pool for liver transplants. The incorporation of DCD grafts into the FDA-approved labeling showcases a growing clinical emphasis on preservation strategies aimed at optimizing graft conditioning before implantation.

Clinical Validation and Practical Implications

The FDA's clearance was backed by results from the Bridge to HOPE study — a multicenter, randomized controlled trial conducted in the U.S. This study focused on end-ischemic, hypothermic, oxygenated portal perfusion in adult liver transplants, involving 219 recipients across 15 transplant centers, including both DBD (donation after brain death) and DCD organs.

The statistically significant outcomes of this study provided the foundation for FDA's De Novo decision, showcasing improved early graft function while maintaining a robust safety profile. The results underline the potential of VitaSmart™ to enhance clinical outcomes and operational efficiencies for transplant centers.

In terms of operational considerations, the approved application of VitaSmart™ includes aspects designed to facilitate:

• - Improved organ utilization rates
• - Reduced reliance on downstream resources
• - Simplified workflow integration without the need for transport-based perfusion
• - A capital-efficient, scalable approach to advanced organ preservation

As transplant programs face mounting pressures to align clinical outcomes with operational complexities and resource constraints, these economic and operational benefits are becoming increasingly vital.

The Future of Organ Preservation

VitaSmart™ achieves hypothermic oxygenated perfusion by cooling the donor liver to controlled hypothermic temperatures while providing an oxygenated perfusate prior to transplantation. Designed with reliability, simplicity, and ease of use in mind, it is set to be utilized in a variety of transplant centers under its FDA-approved indications.

In conclusion, the achievement of FDA approval by Bridge to Life™ indicates a significant step toward improving practices in organ preservation through the application of innovative technology. The contributions of researchers, transplant teams, and the dedication of Bridge to Life™ personnel have culminated in this milestone worth celebrating.

More details on VitaSmart™ and its capabilities can be found on Bridge to Life's official website at www.bridgetolife.com.