#United States #Duluth #VitaSmart #Bridge to Life #Liver Transplant

FDA Approval Marks a New Era in Liver Transplant Preservation

In a significant stride for the field of organ transplantation, Bridge to Life™ Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted De-Novo clearance for its VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) system. This groundbreaking approval marks the first ever FDA authorization for cold machine perfusion technology aimed at preserving liver transplants in the United States.

What is the VitaSmart HOPE System?

The VitaSmart HOPE system is designed to enhance the preservation of donor livers, particularly those obtained from donors after circulatory death (DCD). The system ensures that livers are maintained at controlled hypothermic temperatures while being perfused with oxygenated solutions prior to transplantation. This innovation not only helps uphold organ viability but also significantly increases the chances of successful transplant outcomes.

The FDA's approval allows for commercial use of the VitaSmart system, paving the way for transplant centers in the U.S. to integrate it into their clinical practices and move forward under established protocols that prioritize patient outcomes.

Implications of the FDA Clearance

Bridge to Life's CEO, Don Webber, called the FDA clearance a milestone for the company and a major advancement for liver transplantation in America. He emphasized the system’s potential to improve organ utilization rates and provide a clinical and economic advantage. The FDA’s determination focused on the system's demonstrated safety and efficacy, aligning it with real-world transplantation practices.

The regulatory clearance also positions VitaSmart as a scalable and economically viable option for transplant programs, especially those considering the use of DCD livers, which are increasingly positioned as a vital component of modern liver transplant strategies.

Supporting DCD Liver Utilization

Livers from DCD donors represent an important category in today’s transplant landscape. The FDA approval of the VitaSmart system reflects an acknowledgment of the clinical benefits associated with hypothermic oxygenated perfusion in managing these livers before implantation. Prominent transplant surgeon Dr. Kristopher Croome from the Mayo Clinic noted that having a FDA-approved system will bolster ongoing efforts to optimize preservation strategies, allowing for greater flexibility in transplantation logistics.

Real-World Application and Clinical Evidence

The FDA’s approval was substantiated by findings from the Bridge to HOPE clinical study, a multicenter, randomized controlled trial conducted in the U.S. The study evaluated the outcomes of hypothermic oxygenated portal vein perfusion in adult liver transplant patients and demonstrated statistically significant improvements in early transplant function. The research involved 219 recipients across 15 participating transplantation centers, confirming the feasibility and safety of the VitaSmart system.

The study's notable success is pivotal for encouraging transplantation programs to adopt new techniques aimed at enhancing organ viability and recipient outcomes. Moreover, the FDA-approved labeling of VitaSmart supports the preservation of donor livers from both brain-dead and DCD donors, provided they meet specific criteria.

Marketing and Future Prospects

As Bridge to Life prepares for an anticipated launch of VitaSmart in the first quarter of 2026, the company has appointed David Castiglioni as Chief Commercial Officer to lead its market strategy. Castiglioni brings extensive experience from the transplantation sector, which will be crucial in navigating the complex landscape of healthcare providers and integration of the VitaSmart system into clinical settings.

The planned commercial strategy will leverage Bridge to Life’s existing network and relationships within the transplantation community, enabling a smoother transition to market for this revolutionary technology.

Conclusion

The launch of the VitaSmart HOPE system represents a significant improvement in organ preservation technology, specifically for liver transplants. With the clear potential to improve clinical outcomes and viability of organs, this innovative system marks a pivotal moment for transplantation practices in the United States. Further studies and real-world implementations will undoubtedly contribute to the evolving field of organ transplantation, emphasizing the need for continued innovation to improve patient care and life-saving outcomes. For more information on Bridge to Life and the VitaSmart system, visit www.bridgetolife.com.