#USA #FDA Approval #VitaSmart #Bridge to Life #Duluth, Georgia

Bridge to Life's Revolutionary Approval in Organ Preservation

Introduction
In an exciting development for the field of transplantation, Bridge to Life™ Ltd. has received FDA De Novo clearance for its innovative VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) system. This groundbreaking announcement, made on January 20, 2026, marks the first time cold machine perfusion for liver transplant preservation has received regulatory approval in the United States.

Significance of the FDA Clearance

The FDA clearance is a game changer that paves the way for the commercial use of the VitaSmart™ system. Specifically designed for the hypothermic oxygenated perfusion of donor livers following a static cold storage phase, this system promises to transform liver transplantation practices significantly across U.S. transplant centers. Don Webber, CEO of Bridge to Life™, emphasized the implications of this breakthrough, stating, "This clearance represents a transformational milestone for Bridge to Life and an important advancement for liver transplantation in the United States."

Expanding Opportunities for Donation After Circulatory Death (DCD)

An exciting aspect of the FDA's decision is the expanded labeling of DCD grafts, a crucial category in modern liver transplantation. DCD grafts are increasingly important, and incorporating them into the FDA-cleared labeling highlights the potential for improved organ preservation strategies. Kristopher Croome, MD from the Mayo Clinic Florida, praised the availability of an FDA-cleared system for DCD grafts, stating that it provides essential flexibility for transplant teams in managing these organs effectively before implantation.

Real-World Application of the VitaSmart™ System

The FDA-cleared indication for the VitaSmart™ system allows hypothermic oxygenated perfusion for liver donors from both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD). This broad application signifies a commitment to clinical relevance, especially as there is no specified maximum duration for machine perfusion. This flexibility means clinicians can deploy the technology and protocols best suited to their specific needs, without the pressure of strict time constraints, leading to optimized intraoperative stability and improved post-transplant outcomes.

Clinical Evidence and Trials

The FDA's De Novo clearance stems from the successful Bridge to HOPE pivotal clinical trial, which involved 219 recipients at 15 U.S. transplant centers. This study showed statistically significant improvements in early graft function with the newly approved technology, corroborating the system's strong safety profile. The data not only supported the FDA's determination but also showcased the potential for enhanced graft management and patient outcomes.

Economic and Operational Advantages

The VitaSmart™ system is purposefully engineered to improve organ utilization while reducing complexity for transplant centers. It enables a capital-efficient approach to organ preservation and eases workflow processes, all critical concerns for healthcare providers. Stakeholders are optimistic that the system will mitigate resource utilization issues and streamline transplantation logistics, which are often plagued by challenges under traditional methods.

Anticipated Launch Plans

Looking ahead, Bridge to Life has laid out a structured plan for the U.S. commercial launch of the VitaSmart™ system, aimed for the first quarter of 2026. This initiative will be spearheaded by David Castiglioni, the newly appointed Chief Commercial Officer, who brings significant experience to the role. The launch aims to harness existing infrastructure while leveraging strong ties to the transplant community, ensuring successful adoption across centers.

Conclusion

The introduction of VitaSmart™ promises not just to change the landscape of liver transplantation but also to affirm Bridge to Life's integral role in advancing organ preservation science. As they prepare for commercialization, the anticipation within the medical and transplant communities is palpable. With the sincerity of gratitude expressed by Webber towards the teams that brought this milestone to fruition, it’s clear that this achievement is a collective effort to push the boundaries of what is possible in organ transplantation today.

For more information, please visit Bridge to Life's website.