As you all know by now, Bridge to Life recently secured U.S. FDA De Novo clearance for our VitaSmart^™ Hypothermic Oxygenated Perfusion (HOPE) System for donor livers following static cold storage and prior to transplantation. This marks our team’s 5th FDA 510k clearance in the past 12 months, and we still have much more to deliver. More about that in the near future.

Significantly, the VitaSmart^™ HOPE System represents the first-ever U.S. approval for cold machine perfusion in liver transplant preservation, establishing a new regulatory classification for hypothermic oxygenated perfusion in liver transplantation in the United States.

The FDA-cleared labeling supports broad clinical applicability, including Donation after Circulatory Death (DCD) donors, and positions VitaSmart™ as a scalable and economically compelling platform for U.S. transplant centers.

Donation after Circulatory Death (DCD) grafts represent an important donor category in contemporary liver transplantation. Inclusion of DCD grafts within the FDA-cleared labeling reflects clinical interest in preservation strategies intended to support graft management prior to implantation.

Upon receiving news of the FDA clearance, Bridge to Life^™ Ltd. CEO and President Don Webber remarked: “This clearance represents a transformational milestone for Bridge to Life and an important advancement for liver transplantation in the United States. VitaSmart^™ is the first FDA-cleared hypothermic oxygenated perfusion system for liver transplantation, and the labeling reflects FDA’s determination of safety and effectiveness, aligned with real-world transplant practice. We believe this will support adoption, contribute to improved organ utilization, and offer meaningful clinical and significant economic value to transplant programs.”

Importantly, the cleared indication does not specify a maximum machine perfusion duration, allowing clinicians to apply hypothermic oxygenated perfusion within the scope of the indication using clinical judgment and established protocols. Extended HOPE duration provides operational and patient safety advantages, including improved coordination of transplantation logistics, avoidance of rushed implantation, and reduced risk of re-exposure to static cold ischemia. These factors directly impact intraoperative stability and post-transplant outcomes.

The organ transplantation community is already anticipating the incorporation of VitaSmart^™ and HOPE into clinical practice. This, from Kristopher P. Croome, MD, Professor of Surgery and Transplant and Hepatobiliary Surgeon at Mayo Clinic Florida: “Having an FDA-cleared hypothermic oxygenated perfusion system commercially available represents an important development for transplant programs. The availability of VitaSmart’s HOPE technology under FDA-cleared labeling, supports ongoing efforts to optimize preservation strategies, particularly with DCD liver grafts. Without a fixed perfusion duration limitation, this represents an important advancement and underscores the FDA’s recognition of hypothermic oxygenated perfusion as a safe and clinically meaningful approach to liver preservation, empowering transplant teams with greater flexibility to deliver the best possible care to patients in need.”

Within the scope of its cleared use, VitaSmart^™ is designed to support:

• Improved organ utilization
• Reduced downstream resource utilization
• Simplified workflow integration without the need for transport-based perfusion
• A capital-efficient, scalable approach to advanced organ preservation

These considerations are increasingly important as transplant programs balance clinical outcomes, operational complexity, and resource constraints. Potential economic and operational benefits may vary by center and clinical practice.

At the recently held 51^st Annual Meeting of the North American Transplant Coordinators Organization (NATCO) in Grapevine, Texas, February 15-18, 2026, Bridge to Life was proud to sponsor a session titled:

“Optimizing Coordination in the Era of Advanced Preservation: Practical Insights from the Field”

The purpose of the session was to explore evolving roles of transplant coordination in the context of advanced preservation strategies.

The following speakers and presentations were included:

Daniel Lebovitz, MD – Medical Director, Donor Alliance
“From Ice to Innovation: How Machine Perfusion is Changing Coordination on the Ground”

• Real-world logistics of coordinating MP cases vs. traditional SCS
• How timelines, staffing, and transport planning differ
• Case examples
• Tips for managing uncertainty in borderline cases

Chase Wehrle, MD, Transplant Surgery, Cleveland Clinic
“Hypothermic Oxygenated Perfusion: What Every Coordinator Should Know”

• Basic science: what HOPE does and how it protects the graft
• Clinical evidence and graft outcomes (focus on liver)
• Viability assessment in the MP era – focus on HOPE

Bryan Bennett, Organ Machine Perfusion Manager, CORE
“Preparing for What’s Next: Coordinating Perfusion in Complex Grafts”

• Emerging technologies and how they affect logistics/workflow
• Differences in workflow when combining NRP and MP
• Lessons from failed logistics-how coordination can make or break a perfusion case

The session was well attended, and we thank NATCO for allowing us to bring this topic to its attendees.

Bridge to Life is looking forward to the upcoming International Liver Transplantation Society (ILTS) 2026 Consensus Conference to be held in Washington, DC, March 6-7, 2026.

This year’s conference is themed: “SHAPING THE GLOBAL STANDARD: CLINICAL TRIALS, BIOMARKERS AND AI IN LIVER TRANSPLANTATION.”

This 2-day event will bring together over 100 international experts, including transplant surgeons, hepatologists, scientists, educators, and thought leaders, to generate consensus statements on critical issues that will reshape the future of liver transplantation.

The conference will focus on the major challenges that liver transplantation faces today:

• Clinical trials remain hampered by heterogeneity, inconsistent endpoints, and limited long-term tracking.
• Biomarkers lack robust validation and clear pathways for global clinical implementation.
• Artificial intelligence holds great promise but is constrained by concerns around data quality, bias, and transparency.

Bridge to Life will be sponsoring a symposium at the conference entitled “Beyond Preservation: Redefining Liver Transplantation with HOPE. Speakers include Dr. David Foley from University of Wisconsin, Dr. Andrea Schlegel from Cleveland Clinic, and Dr. David Axelrod from University Hospital Cleveland. You can find more information here.