#USA #FDA Approval #VitaSmart™ #Bridge to Life™ #Duluth, GA

Bridge to Life™ Gains FDA Authorization for VitaSmart™

A New Era for Liver Preservation

In a landmark development for liver transplantation, Bridge to Life™ Ltd. has achieved a significant breakthrough by securing De Novo authorization from the US Food and Drug Administration (FDA) for its groundbreaking hypothermic oxygenated perfusion system, VitaSmart™ (HOPE). This marks the first-ever FDA approval for cold machine perfusion technology in the preservation of liver grafts in the United States, setting a precedent in the field of organ transplantation.

The FDA's authorization paves the way for the commercial use of VitaSmart™, enabling the hypothermic oxygenated perfusion of livers from donors after cold static storage prior to transplantation. It provides American transplant centers with a regulated pathway to seamlessly integrate HOPE protocols into their clinical practices.

Transformational Impact on Transplantation

As highlighted by Don Webber, the CEO and President of Bridge to Life™, this approval signifies a transformational milestone not only for the company but also for the future of liver transplantation in the country. The system represents the FDA's commitment to ensuring safety and efficacy, thus aligning with practical transplantation experiences. Webber stated, “We believe this will foster wider adoption, improve organ utilization, and deliver significant clinical and economic value to transplant programs.”

One of the key advantages of the previously unregulated use of DCD (Donation after Circulatory Death) grafts is included in the approved labeling for VitaSmart™, reflecting the increasing clinical interest in preservation strategies that support the management of organs before implantation.

Clinical Implications and Flexibility

Dr. Kristopher Croome, a leading transplant surgeon at Mayo Clinic Florida, commented on the clinical implications of the VitaSmart™ technology, stating that the arrival of an FDA-approved hypothermic oxygenated perfusion system would enhance transplantation programs significantly. The FDA's authorization supports the use of the HOPE technology particularly with DCD livers, providing transplant teams the flexibility needed to ensure optimal patient care.

Moreover, the labeling does not include the maximum duration for machine perfusion, allowing clinicians to apply their clinical judgement when deciding on perfusion periods. Extending the duration of HOPE carries both operational and patient safety benefits, such as better logistics coordination, the avoidance of rushed transplantation, and reduced risk of re-exposure to static cold ischemia. These factors are crucial for ensuring both perioperative stability and improved post-transplant outcomes.

Evidence-Based Foundation for Approval

The FDA's De Novo authorization is grounded in robust data derived from the pivotal clinical trial, Bridge to HOPE, a multicenter, randomized, controlled study conducted across 15 US transplant centers. The study evaluated hypothermic oxygenated perfusion via the portal vein at the end of ischemia during adult liver transplantation. Encompassing 219 recipients, including expanded criteria donor populations for both DBD and DCD, the statistically significant clinical outcomes have established a strong safety profile and enhanced early graft function.

Economic and Operational Considerations

The implementation of VitaSmart™ underlines several economic and operational benefits for transplant centers, including:

• - Enhanced organ utilization
• - Resource utilization reduction
• - Streamlined workflow integration without the need for transport perfusion
• - A scalable and capital-efficient alternative for advanced organ preservation

These factors are increasingly vital as transplantation programs navigate the complexities of clinical outcomes amidst operational challenges and resource constraints.

Future Directions and Leadership

To facilitate the launch of VitaSmart™ in the United States, Bridge to Life has appointed David Castiglioni as Chief Commercial Officer. His extensive experience in the transplantation sector and collaboration with healthcare providers positions him well to lead the commercialization of VitaSmart™ while supporting the company's expansive portfolio of patented solutions.

The commercial launch is anticipated in the first quarter of 2026, leveraging the company’s established commercial infrastructure and long-term relationships within the transplant community.

Innovative Technology for Improved Care

VitaSmart™ works by cooling donor livers under controlled hypothermic temperatures while administering oxygenated perfusate prior to transplantation. Designed for reliability and ease of use, this system is expected to be widely adopted across numerous transplant centers, promoting enhanced care under the FDA-approved indication.

Acknowledgements

“Lastly, I would like to extend my sincere gratitude to the researchers, transplant teams, and clinical staff at the 15 transplant centers that participated in the Bridge to HOPE study, as well as to the Bridge to Life team whose dedication and scientific rigor brought this milestone to fruition,” stated Webber. “This authorization is the result of years of collaboration and meticulous clinical execution, and we are deeply grateful to everyone who contributed to this achievement.”

About Bridge to Life™ Ltd.

Bridge to Life™ Ltd. is a global leader in organ preservation solutions, offering a comprehensive portfolio that includes Belzer UW®, EasiSlush®, and the VitaSmart™ Hypothermic Oxygenated Perfusion System. Collaborating with transplant centers and organ procurement organizations worldwide, Bridge to Life advances the science of organ preservation, ultimately supporting life-saving transplants.