FDA Grants De Novo Approval to Bridge to Life’s VitaSmart™ HOPE System for Liver Transplantation

Bridge to Life™ Ltd., a global innovator in organ preservation and perfusion technologies, announced that the U.S. Food and Drug Administration (FDA) has granted de novo approval to its VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) system.

The decision establishes a new FDA regulatory classification for hypothermic oxygenated perfusion in liver transplantation in the United States.

The approval enables commercial use of VitaSmart™ for hypothermic oxygenated perfusion of donor livers after static cold storage and before transplantation, providing U.S. transplant centers with a clear, regulated pathway to integrate HOPE protocols into routine clinical practice.

A first-of-its-kind FDA approval

VitaSmart™ is the first FDA-approved hypothermic oxygen perfusion system for liver transplantation in the U.S.

“This approval is a milestone for Bridge to Life and an important advancement for liver transplantation,” said Don Webber, CEO and President of Bridge to Life™ Ltd.
“The FDA’s designation reflects demonstrated safety and efficacy aligned with real-world transplantation practice and may improve organ utilization while delivering meaningful clinical and economic benefits.”

Expanding use of DCD livers

The FDA-approved labeling explicitly supports use in donation after circulatory death (DCD) livers, an increasingly important donor category.

Dr. Kristopher Croome, Professor of Surgery and Transplantation at Mayo Clinic Florida, noted that FDA-approved HOPE technology supports optimization of preservation strategies for DCD grafts.

Notably, the approval does not impose a fixed limit on perfusion duration, offering transplant teams greater operational flexibility and supporting safer, more controlled implantation timing.

Labeling aligned with real-world practice

The approved indication allows hypothermic oxygenated perfusion of donor livers from both:

• Donation after brain death (DBD) donors
• Donation after circulatory death (DCD) donors

Key clinical advantages supported by the label include:

• Flexibility in perfusion duration based on clinical judgment
• Reduced re-exposure to static cold ischemia
• Improved transplant logistics and coordination
• Potential benefits for intraoperative stability and post-transplant outcomes

Clinical evidence supporting approval

FDA de novo clearance was supported by data from the Bridge to HOPE clinical trial, a multicenter, randomized, controlled U.S. study.

Study highlights:

• 219 adult liver transplant recipients
• 15 U.S. transplant centers
• Inclusion of expanded-criteria DBD and DCD donors
• Statistically significant improvements in early graft function
• Strong overall safety profile

These results formed the clinical basis for the FDA’s decision.

Economic and operational considerations

Within its approved use, VitaSmart™ is designed to support:

• Improved donor organ utilization
• Reduced downstream healthcare resource use
• Simplified workflow without transport-based perfusion
• Capital-efficient, scalable adoption

These factors are increasingly relevant as transplant programs balance outcomes, cost pressures, and operational complexity.

U.S. launch plans

Bridge to Life plans to commercially launch VitaSmart™ in the U.S. in Q1 2026.

The launch will be led by David Castiglioni, recently appointed Chief Commercial Officer, and will leverage the company’s existing transplant-focused commercial infrastructure.

About VitaSmart™ HOPE technology

VitaSmart™ delivers controlled hypothermic oxygenated perfusion, cooling the donor liver while supplying oxygenated perfusate prior to transplantation.

The system is designed for reliability, simplicity, and ease of use, enabling adoption across a range of transplant center settings within its FDA-approved indication.

About Bridge to Life™ Ltd.

Bridge to Life™ Ltd. is a global provider of organ preservation solutions, offering products such as Belzer UW®, EasiSlush®, and the VitaSmart™ Hypothermic Oxygenated Perfusion System. The company partners with transplant centers and organ procurement organizations worldwide to advance preservation science and support life-saving transplants.

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