Bridge to Life Ltd. has received De Novo clearance from the United States Food and Drug Administration for the VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System, making it the first machine perfusion platform approved for cold liver preservation in the United States. The clearance establishes a new regulatory classification and enables the commercial launch of VitaSmart for hypothermic oxygenated perfusion of donor livers, including Donation after Circulatory Death (DCD) grafts, starting in the first quarter of 2026.

What this De Novo clearance changes for liver transplantation workflows and HOPE adoption

The regulatory milestone not only clears the path for Bridge to Life’s VitaSmart system in the U.S. market but also formalizes hypothermic oxygenated perfusion as a recognized transplant modality with codified clinical labeling. That shift carries operational, clinical, and reimbursement consequences for transplant centers that have so far relied on static cold storage or investigational machine perfusion protocols. It also introduces a new level of regulatory certainty for perfusion strategies that have long been supported in European practice but lacked formal FDA recognition.

Until now, hypothermic oxygenated perfusion remained in a grey zone within U.S. transplant logistics, often implemented under research protocols or compassionate use frameworks. The De Novo pathway has now classified HOPE under a distinct regulatory label—freeing institutions from investigational device burdens and aligning clinical judgment with a scalable, cleared platform. The absence of a fixed perfusion duration restriction in the FDA’s approved labeling further enables transplant teams to synchronize surgical schedules and donor-recipient logistics without the constraints imposed by prior-generation or warm-perfusion platforms.

Industry analysts note that this distinction could accelerate adoption across high-volume transplant centers where the capacity to delay implantation without compromising graft viability is increasingly critical. As liver transplant programs face mounting organ scarcity and seek to increase the utilization of extended-criteria grafts—including those from DCD donors—hypothermic oxygenated perfusion offers a compelling bridge between safety, flexibility, and resource efficiency.

How VitaSmart compares with existing machine perfusion and cold storage approaches

The VitaSmart system enters a competitive but fragmented market where preservation methods range from static cold storage (SCS), still dominant in the U.S., to ex vivo warm perfusion and proprietary normothermic machines used off-label or under FDA investigational protocols. Unlike normothermic perfusion, which requires continuous monitoring and has more complex fluidics and oxygenation requirements, VitaSmart’s HOPE method operates at hypothermic temperatures using portal venous access, enabling more streamlined use in clinical settings.

While normothermic platforms have demonstrated promise in improving graft viability, particularly in marginal organs, their deployment remains cost-intensive and logistically demanding. In contrast, VitaSmart positions itself as a capital-efficient, workflow-compatible system that supports adoption in both large academic centers and mid-volume transplant programs. The FDA-cleared labeling for both DBD and DCD donors further broadens the scope of use, reducing the clinical ambiguity often associated with organ categorization and preservation strategies.

Clinicians tracking liver transplantation evolution have noted that the strongest near-term impact of HOPE systems like VitaSmart may lie in improving the viability of DCD grafts—a donor category that remains underutilized in the United States due to concerns over ischemia-reperfusion injury and delayed graft function. Bridge to Life’s platform, with its hypothermic perfusion protocol post-cold storage, is designed to mitigate precisely those concerns.

Why FDA’s labeling decisions on perfusion duration and DCD inclusion are significant

One of the more consequential aspects of the FDA’s decision is the absence of a maximum machine perfusion duration in the VitaSmart labeling. That exclusion, while subtle, empowers transplant surgeons to apply their own protocols and timing decisions based on intraoperative and logistical needs, as long as they remain within donor criteria specified in the labeling. It also suggests a degree of regulatory flexibility that aligns with real-world complexity, rather than enforcing rigid thresholds often out of step with clinical reality.

Regulatory observers suggest that the FDA’s recognition of DCD grafts within the product labeling signals a deliberate shift toward enabling wider utilization of non-traditional donor sources. That positioning could influence future reimbursement policy, procurement workflows, and even organ allocation algorithms, depending on how aggressively transplant centers choose to reconfigure their acceptance criteria in light of this clearance.

Notably, the FDA’s clearance follows the completion of the Bridge to HOPE pivotal trial, which enrolled 219 recipients across 15 U.S. centers. The inclusion of both DBD and DCD grafts in the trial population and the statistically significant improvement in early graft function underpin a relatively high degree of clinical confidence—though longer-term data and head-to-head performance against normothermic systems are still needed.

What transplant centers must now evaluate: Cost, integration, and data expectations

The introduction of VitaSmart into the U.S. market sets up an inflection point for transplant centers, many of which have grown accustomed to the simplicity and low-cost profile of static cold storage, despite its limitations. The VitaSmart platform offers several economic and operational propositions, including the ability to improve organ utilization, avoid rushed implantation, and streamline workflow integration without the need for perfusion during transport.

That said, questions remain about procurement strategy, training burden, and per-case cost analysis—especially in the absence of bundled reimbursement codes for machine perfusion. Transplant centers will likely perform individualized assessments of return on investment, evaluating whether the upfront capital and procedural integration costs are offset by downstream gains in reduced ICU stay, fewer reoperations, and improved long-term graft survival.

Manufacturing scalability will also become a concern if uptake outpaces Bridge to Life’s current production capacity. With the first commercial rollout set for the first quarter of 2026, early feedback from launch sites could shape broader perceptions of reliability, user-friendliness, and clinical efficacy in the months ahead.

What comes next: Competitor positioning, data follow-up, and regulatory precedent

Bridge to Life’s FDA win sets a regulatory precedent for HOPE systems that could influence future submissions from competitors or compel existing normothermic platforms to reframe their value propositions. Industry observers anticipate that companies active in perfusion technology may pivot toward De Novo or 510(k) submissions, depending on the FDA’s evolving stance.

Furthermore, the durability of the Bridge to HOPE study’s results over time, especially with regard to 1-year graft survival, re-transplantation rates, and patient quality of life, will be key to institutional confidence. Additional real-world evidence collected under the cleared labeling could eventually support payer coverage decisions, especially if comparative effectiveness data is made available.

Finally, as liver transplantation increasingly incorporates marginal and extended-criteria donors—including older grafts and donors with comorbidities—VitaSmart may offer a platform for adjunctive therapies, such as gene silencing, immunomodulation, or pharmacologic conditioning during perfusion. That could move the field from preservation toward graft enhancement, further elevating HOPE from a bridge technology to a transformative clinical modality.

  Bridge to Life, DCD liver grafts, FDA De Novo clearance, HOPE system, Hypothermic Oxygenated Perfusion, liver transplantation, organ preservation, perfusion devices, VitaSmart