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Bridge to Life™ Secures FDA De Novo Clearance for the VitaSmart™ HOPE System

Bridge to Life™ Ltd, a renowned leader in organ preservation and perfusion technology, announced a monumental achievement today. The U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) system. This makes it the first device of its kind approved in the United States for the hypothermic oxygenated perfusion of donor livers.

The FDA's approval paves the way for commercial utilization of the VitaSmart™ system, enabling hypothermic oxygenated perfusion of donor livers following static cold storage prior to transplantation. This regulatory milestone offers a clear and safe pathway for American transplant centers to incorporate HOPE protocols into their clinical practices.

According to Don Webber, CEO and President of Bridge to Life™ Ltd, "This authorization represents a transformative moment for our company and significant advancement for liver transplantation in the U.S. The VitaSmart™ system is the first FDA-approved device for hypothermic oxygenated perfusion for liver transplants, and its labeling underscores the FDA's commitment to safety and efficacy, aligned with real-world transplant practices. We believe this will foster adoption, improve organ utilization, and create substantial clinical and economic value for transplant programs."

Expanding the Possibilities for DCD Donors

Donors after Circulatory Death (DCD) represent one of the most significant opportunities to enlarge the pool of available organs for liver transplants. The inclusion of DCD grafts in the FDA-approved labeling reflects the increasing clinical interest in preservation strategies designed to support graft conditioning before implantation.

Dr. Kristopher Croome, a professor of surgery and transplantation at Mayo Clinic Florida, emphasized the importance of having FDA-approved hypothermic oxygenated perfusion in transplant programs, saying, "The market introduction of an FDA-approved hypothermic oxygenated perfusion system signifies a major development for transplant programs. The availability of HOPE technology via VitaSmart™ under an FDA-approved label supports ongoing efforts to optimize preservation strategies, especially with DCD liver grafts."

An Endorsement for Real-World Clinical Practice

The FDA-approved labeling for VitaSmart™ supports the hypothermic oxygenated perfusion of donor livers before transplantation for both Donation after Brain Death (DBD) and DCD donors, adhering to predefined donor criteria. Notably, the approved indication does not specify a maximum perfusion time for the device, enabling clinicians to apply hypothermic oxygenated perfusion based on their clinical judgment and established protocols.

The authorized labeling ensures that VitaSmart™ can:

• - Support the integration of HOPE into existing transplantation workflows,
• - Allow flexibility in preservation strategies prior to implantation,
• - Offer a user-friendly, back-to-base hypothermic oxygenated perfusion approach.

These features make VitaSmart™ a commercially scalable and economically attractive platform that can be widely adopted in U.S. transplant programs without adding operational complexity or unnecessary costs.

Clinical Evidence Supporting FDA Authorization

The FDA’s authorization is backed by data from the Bridge to HOPE pivotal clinical trial, a multicenter, randomized, controlled study conducted in the U.S. assessing port vein hypothermic oxygenated perfusion at the end of ischemia in adult liver transplantation. The study involved 219 recipients across 15 U.S. transplant centers, including expanded criteria donor populations for both DBD and DCD grafts. The statistically significant clinical outcomes from the trial formed the basis for the FDA’s De Novo determination and demonstrated improved early graft function with a solid safety profile.

Economic and Operational Considerations for Transplant Centers

Under its authorized use, VitaSmart™ is designed to:

• - Enhance organ utilization,
• - Reduce downstream resource utilization,
• - Integrate seamlessly into workflows without the need for transport perfusion,
• - Provide a scalable and capital-efficient approach for advanced organ preservation.

As transplant programs increasingly need to balance clinical outcomes with operational complexity and resource constraints, the potential economic and operational benefits can vary across individual centers and clinical practices.

HOPE Technology Designed for U.S. Adoption

VitaSmart™ delivers hypothermic oxygenated perfusion by cooling donor livers to controlled hypothermic temperatures while providing oxygenated perfusate prior to transplantation. Its design promotes reliability, simplicity, and ease of use, making it well-suited for adoption across numerous transplant centers under the FDA-approved indication.

Gratitude to Researchers and the Team

"I would like to personally thank the researchers, transplant teams, and clinical staff involved in the Bridge to HOPE study, along with the dedication and scientific rigor of the Bridge to Life team that made this milestone possible," said Webber. "This authorization results from years of collaboration and rigorous clinical execution, and we are deeply grateful to everyone involved."

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. The company partners with transplantation centers and organ recovery organizations worldwide to advance the science of preservation and support life-saving transplants. For more information, visit www.bridgetolife.com.