Bridge to Life Reports First U.S. Commercial Adoption of VitaSmart™ HOPE System by Leading Transplant Center Following FDA Clearance, Reflecting Early Physician Confidence

Bridge to Life Reports First U.S. Commercial Adoption of VitaSmart™ HOPE System by Leading Transplant Center Following FDA Clearance, Reflecting Early Physician Confidence

DULUTH, Ga., March 24, 2026 — Bridge to Life™ Ltd., a global leader in organ preservation and perfusion technology, announced that Duke University Hospital has become the first transplant center in the United States to successfully adopt the VitaSmart™ Hypothermic Oxygenated Perfusion (HOPE) System. The hospital has also completed its first successful preservation of a donor liver using the VitaSmart™ HOPE System prior to transplantation. The liver originated from a Donation after Circulatory Death (DCD) donor.

“The ultimate goal is to maximize access for every patient on the transplant waitlist,” said Dr. Andrew Barbas, Associate Professor of Surgery and surgical director of the liver transplant program at Duke University Hospital. “Hypothermic liver perfusion gives our team an additional pathway to help expand the available donor pool for liver transplantation.”

“We are excited to see the VitaSmart™ System successfully used to preserve donor livers ahead of transplantation,” said Don Webber, CEO and President of Bridge to Life™ Ltd. “Following years of clinical use and thousands of liver transplants performed with the VitaSmart™ System across the European Union, this marks an important milestone as the technology becomes available to transplant centers in the United States. The FDA-cleared labeling supports broad clinical use, including DCD donors, and positions VitaSmart™ as a scalable and cost-effective platform for transplant programs nationwide.”

Labeling Aligned with Clinical Practice

The FDA-cleared labeling for VitaSmart™ enables hypothermic oxygenated perfusion of donor livers prior to transplant for both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donors, within defined criteria.

Notably, the indication does not impose a maximum duration for machine perfusion. This allows clinicians to use their judgment and established protocols when determining perfusion time within the scope of the labeling. Longer HOPE durations can offer meaningful operational and safety benefits, including improved coordination of transplant procedures, reduced urgency during implantation, and a lower likelihood of returning the organ to static cold ischemia. These advantages can positively influence both intraoperative stability and post-transplant outcomes.

Purpose-Built HOPE Technology for U.S. Use

The VitaSmart™ System delivers hypothermic oxygenated perfusion by maintaining donor livers at controlled low temperatures while circulating oxygenated perfusate before transplantation. The system is designed with a focus on reliability, simplicity, and ease of use, supporting implementation across a wide range of transplant center settings under its FDA-cleared indication.

Bridge to HOPE Pivotal Clinical Trial

FDA clearance for VitaSmart™ was supported by data from the first multicenter, randomized clinical trial in the United States evaluating end-ischemic HOPE following static cold storage (SCS), compared to SCS alone.

Key findings from the Bridge to HOPE Pivotal Clinical Trial include:

• Early Trial Closure: The study was concluded ahead of schedule after achieving statistical superiority for its primary efficacy endpoint during a pre-defined interim analysis.
• Shorter Hospital Stays: Patients in the HOPE group experienced a statistically significant reduction in hospital length of stay compared to those receiving SCS alone, which may impact healthcare resource use and associated costs.
• Lower Rates of Early Allograft Dysfunction (EAD): Portal venous HOPE was associated with a reduced incidence of EAD, indicating improved early graft function.

Additionally, end-ischemic portal venous HOPE showed trends toward reduced graft failure requiring re-transplantation in DCD cases, decreased steroid-resistant rejection, and fewer biliary complications, all while maintaining a strong safety profile. These findings support HOPE as a safe, practical, and effective method for dynamic liver preservation.

Complementing Established Preservation Solutions

Bridge to Life also offers recently FDA-cleared, multi-sourced Belzer UW® and MPS® organ preservation solutions. The clearance includes expanded labeling for Belzer MPS® UW Machine Perfusion Solution to support use across all abdominal organs, representing a first-of-its-kind advancement in transplantation.

To ensure consistent availability, the company maintains a minimum 60-day global inventory buffer and has secured multiple exclusive supplier agreements in key regions. This strategy strengthens supply chain reliability and enables delivery of tailored solutions to meet evolving customer needs. Combined with longstanding exclusive rights to Belzer UW® and MPS® from the University of Wisconsin, and the addition of BTL-owned EasiSlush®, Bridge to Life has developed a portfolio of trusted preservation solutions supporting transplant procedures for more than a decade.

About Bridge to Life™ Ltd.

Bridge to Life™ Ltd. is a global provider of organ preservation technologies, offering a comprehensive portfolio that includes Belzer UW®, EasiSlush®, and the VitaSmart™ Hypothermic Oxygenated Perfusion System. The company collaborates with transplant centers and organ procurement organizations worldwide to advance preservation science and support life-saving transplant procedures.

For more information, visit www.bridgetolife.com.

SOURCE Bridge to Life, Ltd.