FDA Grants De Novo Clearance for Hypothermic Oxygenated Perfusion Solution

Bridge to Life Ltd. has earned U.S. Food and Drug Administration (FDA) De Novo clearance for the VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System, thereby establishing a new U.S. regulatory classification for hypothermic oxygenated perfusion in liver transplantation.

The FDA clearance allows VitaSmart to be used for hypothermic oxygenated perfusion of donor livers after static cold storage and before transplantation.

“This clearance represents a transformational milestone for Bridge to Life and an important advancement for liver transplantation in the United States,” Bridge to Life President/CEO Don Webber said. “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.”

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

“Having an FDA-cleared hypothermic oxygenated perfusion system commercially available represents an important development for transplant programs,” said Kristopher Croome, M.D., professor of Surgery and Transplant and hepatobiliary surgeon at Mayo Clinic Florida. “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.”

The FDA-cleared labeling for VitaSmart supports hypothermic oxygenated perfusion of donor livers before transplantation in both DBD and Donation after Circulatory Death (DCD) donors, within defined donor criteria.

Importantly, the cleared indication does not specify a maximum machine perfusion duration, allowing clinicians to apply hypothermic oxygenated perfusion within the indication’s scope 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.

Clinical Evidence Supporting De Novo Clearance

FDA clearance was supported by data from the Bridge to HOPE pivotal clinical trial, a multicenter, randomized controlled study conducted in the United States evaluating end-ischemic portal venous hypothermic oxygenated perfusion in adult liver transplantation.

The study enrolled 219 recipients across 15 U.S. transplant centers, including extended-criteria donor populations in both DBD and DCD grafts. The statistically significant clinical results of the trial formed the basis for FDA’s De Novo determination and demonstrated improvements in early graft function with a strong safety profile.

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.

Bridge to Life has appointed David Castiglioni as chief commercial officer to lead VitaSmart’s U.S. commercialization and support continued growth across the company’s proprietary solutions portfolio. Castiglioni has extensive experience in the transplantation sector and in working with healthcare providers to implement clinically integrated solutions.

Bridge to Life plans to launch VitaSmart in the United States this quarter. The launch will build on the company’s existing commercial infrastructure and longstanding relationships across the transplantation community.

VitaSmart delivers hypothermic oxygenated perfusion by cooling donor livers to controlled hypothermic temperatures while providing oxygenated perfusate before transplantation. The system is engineered for reliability, simplicity, and ease of use, supporting adoption across various transplant center environments under its FDA-cleared indication.

“I want to personally thank the investigators, transplant teams, and clinical staff at the 15 transplant centers in the U.S. who participated in the Bridge to HOPE study, as well as the Bridge to Life team whose dedication and scientific rigor made this milestone possible,” Webber added. “This clearance reflects years of disciplined clinical execution and collaboration, and we are deeply grateful to everyone who contributed.”

Bridge to Life Ltd. provides organ preservation solutions, offering a portfolio that includes Belzer UW, EasiSlush, and the VitaSmart Hypothermic Oxygenated Perfusion System. Bridge to Life partners with transplant centers and organ procurement organizations worldwide to advance preservation science and support life-saving transplantation.