Don Webber’s CEO Perspective #12

To the Organ Transplantation Community,

2026 has already marked a transformative period for liver transplantation and organ preservation. Earlier this year, the U.S. Food and Drug Administration granted De Novo clearance to the VitaSmart^™ Hypothermic Oxygenated Perfusion (HOPE) System, the first FDA-cleared hypothermic oxygenated perfusion system for liver transplantation in the United States.

Importantly, the cleared labeling supports broad clinical application, including both Donation after Circulatory Death (DCD) and Donation after Brain Death (DBD) donor livers. This milestone represents more than the introduction of a new technology platform. It reflects the broader shift within transplantation toward biologically guided organ preservation strategies focused on mitochondrial protection, improved graft utilization, and expanded access to transplantation.

Following FDA clearance, Bridge to Life has begun supporting the implementation of HOPE programs across leading U.S. transplant centers. Duke University Hospital became one of the first major centers in the country to clinically implement the VitaSmart^™ System, successfully preserving and transplanting a DCD donor liver using HOPE. Additional centers, including the University of Rochester Medical Center and Methodist Dallas, have also initiated clinical HOPE programs, with further installations continuing across the United States.

Unlike static cold storage alone, HOPE delivers controlled oxygenation under hypothermic conditions to support mitochondrial recovery and reduce the risk of ischemia-reperfusion injury during transplantation. As clinical experience continues to grow globally, transplant centers are increasingly evaluating how advanced preservation strategies may improve utilization of higher-risk donor organs while supporting post-transplant outcomes and operational efficiency.

The impact of HOPE is already becoming evident at transplant centers implementing the technology. Earlier this month, Methodist Dallas Medical Center shared the story of Linda Williams, a 72-year-old liver transplant recipient who became the first patient at the center to receive a donor liver preserved using the VitaSmart^™ Hypothermic Oxygenated Perfusion (HOPE) System. Following years of declining health while awaiting transplantation, Linda successfully received her transplant in March and has since returned to many of the activities she enjoys with her family.

While scientific evidence, regulatory milestones, and clinical adoption remain critical drivers of progress, stories like Linda’s remind us of the ultimate purpose behind these advances. The ultimate goal of every advancement in organ preservation is to help more patients gain access to life-saving transplantation and improved quality of life. You can read Linda’s story here: Pump gives liver recipient the HOPE she needed.

Innovation surrounding HOPE is also expanding beyond transplant centers themselves. Recently, Life Connection of Ohio became the first organ procurement organization (OPO) in the United States to utilize the VitaSmart^™ Hypothermic Oxygenated Perfusion (HOPE) System as part of its organ preservation process. According to the organization, HOPE perfusion helped facilitate the successful transplantation of a donor liver that was initially not considered suitable for transplant.

This milestone highlights the growing role advanced preservation technologies may play across the broader donation and transplantation ecosystem.

Another major milestone for the field was reached with the publication of the Bridge to HOPE pivotal clinical trial in JAMA Surgery. The study, “Portal-Venous Hypothermic Oxygenated Perfusion for Liver Transplantation: The Bridge to HOPE Trial,” represents the first multicenter randomized U.S. trial evaluating end-ischemic portal-venous HOPE in higher-risk donor livers, including both DCD and DBD grafts. Conducted across 15 U.S. transplant centers and enrolling 219 recipients, the study contributes to the growing body of evidence supporting hypothermic oxygenated perfusion as a clinically meaningful preservation strategy in liver transplantation.  The full publication can be accessed here: Portal-Venous Hypothermic Oxygenated Perfusion for Liver Transplant: A Randomized Clinical Trial | Surgery | JAMA Surgery | JAMA Network.

Scientific engagement and clinical research surrounding HOPE and mitochondrial preservation also continued throughout the spring congress season. At the 30th Annual Meeting of the Society of Pediatric Liver Transplantation (SPLIT), data presented demonstrated the feasibility and safety of HOPE in pediatric liver transplantation, including technically complex grafts and recipients.

At the 2026 International Congress of the International Liver Transplantation Society (ILTS) in Geneva, Bridge to Life supported 12 scientific abstracts, including plenary and oral presentations exploring organ utilization, mitochondrial preservation, and translational research associated with hypothermic oxygenated perfusion. Several studies highlighted the growing role of HOPE in expanding the use of extended-criteria donor livers and supporting viability assessment strategies based on mitochondrial function.

Recent publications also point to applications of HOPE beyond abdominal organ preservation and ischemia-reperfusion management. Just published in the Journal of Clinical Medicine, “First Experience with Hypothermic Oxygenated Perfusion in Human Uteri: Feasibility and Metabolic Characterization,” out of Cleveland Clinic and Wake Forest Baptist for Fertility and Reproductive Surgery, explored the feasibility of hypothermic oxygenated perfusion in human uterine transplantation.   Additional surgical applications have also demonstrated the potential role of controlled hypothermic perfusion in complex hepatic surgery. In Annals of Surgical Oncology, “Two Stage Hepatectomy for Cholangiocarcinoma Under Total Vascular Exclusion with Veno venous ECMO Bypass and Controlled Closed loop In Situ Hypothermic Oxygenated Perfusion of the Liver: The Hannover CLIP Concept,” from Hannover Medical School, Hannover, Germany, describes the use of HOPE and the VitaSmart^™ System during a complex hepatectomy procedure.

We are also encouraged by continued international institutional engagement surrounding machine perfusion technologies. Recently, the UK National Institute for Health and Care Excellence (NICE) published draft guidance recommending the routine use of liver preservation machines within the National Health Service. Bridge to Life’s VitaSmart^™ System was included among the technologies under evaluation. The inclusion of HOPE technologies within these discussions reflects growing recognition of machine perfusion as an increasingly important component of future transplant infrastructure and organ utilization strategies. You can read the discussion here: https://www.nice.org.uk/news/articles/new-machines-that-keep-donor-livers-alive-outside-the-body-could-help-hundreds.

Looking ahead, Bridge to Life remains committed to supporting clinical research, translational science, and broader adoption of advanced preservation technologies across abdominal organ transplantation. At the upcoming American Transplant Congress (ATC) in Boston, scientific presentations will continue to explore the role of HOPE in additional organ applications, including intestinal transplantation and other emerging areas of abdominal perfusion.

Within the scope of its cleared indication, VitaSmart^™ is designed to support:
• Improved organ utilization
• Simplified workflow integration
• Reduced operational complexity
• A scalable and capital-efficient approach to advanced organ preservation

These considerations are increasingly important as transplant centers navigate rising clinical demand, operational constraints, and the ongoing need to safely expand donor organ utilization.

Bridge to Life also continues to support research into mitochondrial biomarkers - most notably flavin mononucleotide (FMN) - and real-time viability assessment, areas that may further inform future decision-making in transplantation and organ acceptance.

FMN is a molecule released from mitochondrial complex I when a donor organ has sustained ischemic injury, and it can be measured directly in the perfusate during hypothermic oxygenated perfusion. Rather than inferring organ quality from donor characteristics, anatomy, or biopsy histology, FMN reports on the biology that actually determines how a graft will perform - the integrity of its mitochondria. The traditional tools used to judge a donor organ, including donor risk indices, biopsy, and measures such as lactate, pH, and transaminases, are largely indirect, static, or retrospective, and many lack validated thresholds for predicting clinically meaningful outcomes. They describe the organ; they do not measure its functional reserve in real time.

FMN, by contrast, can be quantified within the first 30 to 60 minutes of perfusion - before the transplant decision is made - giving the clinical team an objective, quantitative readout of mitochondrial injury at the moment it matters most. A growing international evidence base, including a multicenter validation study spanning ten centers across seven countries, has associated perfusate FMN with graft loss, early allograft dysfunction, and biliary complications. For the first time, the field has a real-time biomarker that aligns precisely with the mechanism HOPE is designed to address: the very mitochondrial injury that FMN measures is the injury that hypothermic oxygenated perfusion works to repair.

This is why Bridge to Life is investing here. Transplantation is moving - from preservation alone toward biologically guided, viability-informed organ assessment - and our intention is to skate to where the puck is going, not to where it is today. We believe the coming decade will be defined less by how organs are stored and more by how confidently their viability can be established before implantation. Our HOPE platform is built to sit at the center of that shift, and our continued research into FMN and related mitochondrial biomarkers is intended to place objective, real-time viability data directly in the hands of the teams making accept-or-decline decisions.

How this technology is adopted matters just as much as the technology itself. Bridge to Life does not simply install a system and step away. We partner with transplant programs to build durable HOPE capabilities - providing training, clinical and scientific support, research collaboration, and access to a growing body of shared evidence and benchmarking. Our goal is to help each center we work with develop into a true center of excellence in machine perfusion and viability-guided transplantation: a program positioned to safely expand its use of higher-risk and extended-criteria donor organs, to contribute to the science, and to deliver consistent outcomes for the patients who depend on it. While FMN is not part of the current VitaSmart™ cleared system, we share it here because we believe the transplant community deserves a clear view of where this field, and our commitment to it, is heading. As the evidence base matures, we look forward to continuing this conversation with the transplant community.

For more information about the VitaSmart^™ Hypothermic Oxygenated Perfusion System, Belzer UW^® Cold Storage Solution, Belzer MPS^® Machine Perfusion Solution, and other Bridge to Life technologies, please visit bridgetolife.com.

We look forward to seeing many of you at ATC 2026 in Boston.

As always, thank you for your continued commitment to advancing transplantation and improving patient access to life-saving organs.

Don Webber
President and Chief Executive Officer
Bridge to Life Ltd.