#USA #FDA Approval #Duluth #Bridge to Life #HOPE VitaSmart

Bridge to Life™ Achieves FDA De Novo Authorization

Bridge to Life™ Ltd., a global leader in organ preservation and perfusion technologies, announced on January 20, 2026, that it has been granted De Novo authorization by the U.S. Food and Drug Administration (FDA) for its HOPE VitaSmart™ system. This groundbreaking development marks the first FDA-approved device for hypothermic oxygenated perfusion (HOPE) of donor livers in the United States.

Significance of the FDA Approval

The FDA authorization allows for the commercial use of the VitaSmart™ system, particularly for hypothermic oxygenated perfusion of donor livers after static cold storage and prior to transplantation. This establishes a clear regulatory pathway for U.S. transplant centers to integrate HOPE protocols into clinical practice.

"This authorization signifies a transformational milestone for Bridge to Life and represents a significant advancement for liver transplantation in the United States," stated Don Webber, CEO and President of Bridge to Life™ Ltd. He emphasized that VitaSmart™ is the first FDA-approved system for hypothermic oxygenated perfusion of the liver, aiming to improve organ utilization and provide substantial clinical and economic value to transplant programs.

Expanding Liver Donor Opportunities

The FDA's approved labeling reflects the rising interest in strategies designed for preserving and optimizing donor liver function, particularly for donations after circulatory death (DCD). This aspect of the authorization is crucial given that DCD donors represent a valuable opportunity for increasing the donor pool.

Dr. Kristopher Croome, a professor of surgery and transplant at Mayo Clinic Florida, noted, "The availability of an FDA-approved hypothermic oxygenated perfusion system presents a significant advancement for transplant programs. The VitaSmart™ technology supports efforts to optimize preservation strategies, especially for DCD liver grafts."

Clinical and Operational Benefits

The FDA-approved labeling for the VitaSmart™ system supports hypothermic oxygenated perfusion for both brain-dead (DBD) and circulatory-dead (DCD) donors. Notably, there is no maximum duration specified for mechanical perfusion, allowing clinicians to apply hypothermic oxygenated perfusion within established clinical protocols based on medical judgment.

Key features of VitaSmart™ include:

• - Integration with Established Workflows: The system facilitates the embedding of HOPE protocols into existing transplant workflows.
• - Flexible Preservation Strategies: It offers flexibility in organ preservation strategies prior to implantation.
• - User-Friendly Design: The device is designed for ease of use without the need for transportation back to the base facility.

These attributes position the VitaSmart™ system as a commercially scalable and economically viable option for widespread adoption among U.S. transplant programs without introducing undue operational complexity or costs.

Clinical Evidence Supporting FDA Authorization

The FDA's authorization is based on data gathered from the Bridge to HOPE clinical trial, a pivotal multi-center, randomized, and controlled study conducted across the United States. This trial evaluated the effectiveness of hypothermic oxygenated perfusion in preserving donor liver function.
The trial enrolled 219 recipients from 15 transplant centers and included extended criteria donor populations in both DBD and DCD grafts. Significant clinical outcomes noted during the trial provided the foundation for the FDA’s De Novo determination.

Economic and Operational Considerations

Within its authorized use scope, the VitaSmart™ is designed to support the following:

• - Better utilization of organs
• - Reduced post-utilization resources
• - Streamlined workflow integration that bypasses the need for transport-based perfusion
• - Scalable and cost-efficient advanced organ preservation strategies

These elements are increasingly vital as transplant programs aim to balance clinical outcomes with operational complexities and resource limitations. The associated economic benefits can vary based on individual center practices.

Conclusion

The VitaSmart™ system represents a pivotal advancement in the field of organ preservation, allowing for better clinical outcomes and operational efficiencies in liver transplantation. Webber expressed gratitude to all participating researchers, transplant teams, and clinical staff, noting, "This authorization reflects years of clinical diligence and collaboration, and we are deeply appreciative of everyone who contributed to this achievement."

About Bridge to Life™ Ltd.

Bridge to Life™ Ltd. is at the forefront of organ preservation solutions, offering a complete portfolio that includes Belzer UW®, EasiSlush®, and the HOPE VitaSmart™ system. The company collaborates with transplant centers and organ procurement organizations globally to enhance preservation science and support life-saving transplants.

For more information, visit www.bridgetolife.com