#United States #Duluth #FDA Clearance #VitaSmart™ #organ preservation

Bridge to Life™ Achieves Groundbreaking FDA Clearance for VitaSmart™ System

In a monumental advancement for liver transplantation, Bridge to Life™ Ltd., recognized for its cutting-edge organ preservation technologies, has recently announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for its innovative VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System. This achievement marks the first-ever FDA approval for cold machine perfusion methods specifically applied to the preservation of livers destined for transplantation in the United States.

A Transformational Moment for Transplantation

Don Webber, the CEO and President of Bridge to Life™, emphasized the significance of this event, stating, "This clearance represents a transformational milestone for Bridge to Life and an important advancement for liver transplantation in the United States." Such a pioneering technology like the VitaSmart™ System not only indicates FDA's acknowledgment of its safety and efficacy but also offers a practical solution aligned with real-world transplant practices. This shift aims to bolster organ utilization rates and provide substantial clinical and economic benefits to transplant programs.

Expanding Utilization Opportunities

With clinical momentum driving the changes in organ donation guidelines, the inclusion of Donation after Circulatory Death (DCD) grafts into the FDA-cleared labeling represents a crucial development. Typically, DCD grafts have posed challenges in the transplantation landscape; however, the introduction of a reliable hypothermic oxygenated perfusion system now empowers transplant centers to optimize preservation methods effectively.

Dr. Kristopher Croome, a Professor of Surgery and Transplant at Mayo Clinic, commented on the innovation’s benefits, stating, "The availability of VitaSmart's HOPE technology under FDA-cleared labeling, supports ongoing efforts to optimize preservation strategies, particularly with DCD liver grafts." The design of the VitaSmart™ System allows for flexibility in clinical application, contributing to improved transplantation outcomes without a limited perfusion duration.

Supporting Real-World Clinical Practice

The FDA clearance specifies that the VitaSmart™ system can be used for donor livers ahead of transplantation for both DCD and Donation after Brain Death (DBD) donors, adhering to defined donor criteria. Importantly, the approved indication does not establish a maximum duration for machine perfusion. This offers clinicians the discretion to extend perfusion, facilitating better logistics and minimizing the risk of rushed procedures that could jeopardize patient outcomes. Key operational advantages include improved intraoperative stability and overall post-transplant recovery.

Clinical Evidence and Economic Impact

The FDA's De Novo determination was backed by outcomes from the Bridge to HOPE clinical trial, a well-designed, multicenter study that assessed the efficacy of hypothermic oxygenated perfusion methods. Conducted across 15 leading transplant centers in the U.S., this trial enrolled 219 patients and notably included extended-criteria donor populations. The results demonstrated improved graft function and maintained a robust safety profile, validating the practical benefits of this new technology.

From an operational standpoint, the VitaSmart™ is structured to deliver:

• - Enhanced organ utilization rates,
• - Reduced need for ancillary resources during transplantation,
• - Streamlined workflow with minimal need for transport-based perfusion.

Such features are pivotal as transplant programs face increasing pressure to improve clinical results while managing resource constraints efficiently.

Path Forward: Launch Plans and Strategy

Bridge to Life™ has strategically positioned itself for a U.S. launch of the VitaSmart™ during the first quarter of 2026. With the appointment of David Castiglioni as Chief Commercial Officer to spearhead this initiative, the company is set to navigate the commercialization landscape effectively, leveraging established relationships within the transplantation community.

Conclusion

VitaSmart™ represents a technological breakthrough that encapsulates years of dedicated research and collaboration. Significantly, this FDA-cleared innovation, which cools donor livers to controlled hypothermic temperatures while facilitating oxygenated perfusion prior to transplantation, prioritizes reliability and user-friendliness over a diverse range of transplant center environments. Director Webber expressed gratitude towards the investigators and numerous clinical staff involved in the study for their invaluable contributions.

This clearance symbolizes not just a win for Bridge to Life™, but an encouraging stride towards advancing organ preservation practices that can save lives throughout the U.S. transplant landscape.