XVIVO has reported late-breaking preliminary data from the PRESERVE Trial evaluating hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport in heart transplantation. The trial met its pre-specified primary endpoints and is expected to support a planned U.S. Food and Drug Administration Pre-Market Approval submission later this year for the investigational heart preservation and transport system.
Why XVIVO’s PRESERVE Trial data could reshape extended donor heart preservation strategies
The significance of the PRESERVE Trial lies in the possibility that heart preservation may be moving from a largely passive logistics model toward a more active preservation strategy. For decades, static cold storage has been the default method for moving donor hearts from procurement to transplantation, but the approach is constrained by time, geography, donor quality, and surgical risk tolerance. XVIVO’s preliminary data puts hypothermic oxygenated perfusion, or HOPE, directly into that pressure point by evaluating whether cold oxygenated perfusion can support donor hearts beyond the traditional preservation window.
The reported finding that 73.8% of cases exceeded the traditional four-hour preservation timeframe is particularly important because time is not just a transport issue in heart transplantation. It directly shapes which organs are accepted, how far they can travel, how confident surgeons feel about marginal hearts, and how flexible transplant programs can be when coordinating complex recipient procedures. If longer preservation can be achieved without compromising early graft function or one-year survival, the clinical and operational implications could be substantial.
However, this is where the distinction between promising data and practice-changing evidence matters. The XVIVO Heart Assist Transport remains investigational in the United States, and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration. The strongest version of the opportunity is that HOPE could help transplant teams use more extended-criteria donor hearts. The main limitation is that regulators and clinicians will need to see whether the benefits remain consistent across donor categories, recipient risk profiles, transport distances, and transplant-center workflows.
What the PRESERVE Trial reveals about the pressure on heart transplant capacity
Heart transplantation faces a structural supply problem that cannot be solved only by improving surgical technique or post-transplant care. The donor pool remains limited, and many donated hearts are not ultimately transplanted because they are viewed as marginal, high-risk, or too logistically difficult to preserve within accepted time limits. XVIVO said only two out of 10 donated hearts are transplanted globally, while 3,456 people in the United States remain on the heart waitlist.
That context matters because the most valuable heart preservation technologies are not merely those that keep ideal organs stable for transport. The bigger commercial and clinical opportunity sits in technologies that can make transplant teams more comfortable accepting organs that might otherwise be declined. Extended-criteria donor hearts, including hearts from older donors or donors with multiple risk factors, represent a major area of unmet need because these organs could help expand access if preservation risk can be better managed.
The PRESERVE Trial enrolled 141 transplant recipients across 14 U.S. centers from October 2023 to November 2024, giving the preliminary dataset more relevance than a narrow single-center experience. Multi-center participation is important because heart transplant programs differ in donor selection philosophy, surgical workflow, transport coordination, and willingness to accept higher-risk organs. If the full dataset shows consistent performance across sites, that would strengthen the case that the technology is not dependent on one highly specialized team or unusually controlled workflow.
Still, transplant adoption is not driven by headline percentages alone. Clinicians will want to examine how many of the enrolled hearts were donation after brain death, donation after circulatory death, or extended-criteria donor hearts with specific risk features. They will also want clarity on preservation duration, recipient characteristics, perioperative management, device performance, and adverse event patterns. Without that granularity, early results may be encouraging but not yet enough to fully change organ acceptance behavior.
How XVIVO Heart Assist Transport may challenge the limits of static cold storage
Static cold storage is simple, familiar, and deeply embedded in heart transplantation logistics, but it has a major weakness: it does not actively support the organ during transport. HOPE takes a different approach by circulating a cold, oxygenated solution through the donor heart before transplant. The clinical logic is that oxygenated perfusion may help preserve organ quality more effectively than cooling alone, particularly when preservation time is extended or donor-heart risk is higher.
That makes the XVIVO Heart Assist Transport potentially relevant not only as a device but as a workflow-changing preservation platform. For hospitals, organ procurement teams, and transplant surgeons, an active preservation system could create more flexibility in matching donors and recipients across longer distances. It may also reduce pressure on surgical teams that currently operate within tight transport windows where delays can quickly alter clinical decision-making.
The comparison with static cold storage, however, will not be settled only by efficacy data. Static cold storage has the advantage of being cheap, portable, and operationally familiar. Any perfusion-based system must justify added complexity, cost, training requirements, device logistics, and potential reimbursement hurdles. Transplant centers will need to assess whether the clinical upside is strong enough to offset the operational burden.
This is why the PRESERVE Trial’s endpoint structure matters. The primary effectiveness endpoint assessed absence of severe primary graft dysfunction, death, re-transplantation, or mechanical support at day 30. XVIVO reported a 92.1% success rate for that endpoint, significantly above the pre-specified performance goal. That composite endpoint is clinically meaningful because it reflects the risks transplant teams worry about most when considering higher-risk donor hearts. Yet composite endpoints can also mask variation between individual components, so the full breakdown will be important for interpreting the data.
Why one-year survival data will be central to regulatory and clinical confidence
The reported 91.4% survival rate at day 365 gives the PRESERVE Trial an important longer-term signal beyond early procedural success. In heart transplantation, early graft function is critical, but one-year survival is often a more persuasive measure of whether a preservation strategy supports durable clinical outcomes. For regulators, payers, and transplant programs, the combination of early effectiveness and one-year survival will be central to the eventual risk-benefit assessment.
The one-year safety endpoint also helps address a key concern with extended preservation technologies. If longer preservation time enables more donor hearts to be used but introduces downstream complications, the clinical value proposition weakens quickly. Conversely, if extended preservation can be paired with acceptable one-year survival, transplant programs may become more willing to reconsider donor hearts that were previously seen as too risky or too difficult to move within the conventional timeframe.
The unresolved issue is how the 365-day survival rate compares against the specific risk profile of the enrolled population. Extended-criteria donor hearts are not uniform. A heart from an older donor, a DCD heart, and a heart with multiple donor risk factors may each carry different clinical concerns. The more clearly XVIVO can show performance across these subgroups, the stronger the case for broader clinical adoption.
Regulatory watchers will also examine whether the performance goals used in the trial provide an appropriate benchmark. Meeting a pre-specified performance goal is encouraging, but the U.S. Food and Drug Administration’s review will likely probe the assumptions behind those goals, the statistical robustness of the dataset, and whether the observed outcomes are strong enough to support approval for the proposed indication.
What the FDA Pre-Market Approval process may test next for XVIVO
XVIVO’s planned Pre-Market Approval submission is the next major inflection point. The PMA route is demanding because it requires substantial evidence that a device is safe and effective for its intended use. For an investigational heart preservation system, that means the U.S. Food and Drug Administration will likely examine clinical outcomes, device reliability, protocol adherence, adverse events, manufacturing controls, labeling, and human factors.
For XVIVO, the strategic opportunity is clear. A successful PMA pathway could position the XVIVO Heart Assist Transport as a regulated preservation option in a high-value transplant segment where unmet need is substantial. It could also strengthen XVIVO’s broader identity as a dedicated organ preservation technology company at a time when transplant systems are searching for ways to increase organ utilization without compromising outcomes.
The regulatory risk is equally clear. Preliminary data may support submission, but approval is not automatic. The U.S. Food and Drug Administration may request more detailed subgroup analyses, additional follow-up, manufacturing clarifications, or post-approval study commitments. Regulators may also pay close attention to how the technology is described in labeling, especially if claims around extended preservation time and donor utilization depend on specific donor categories or operating conditions.
The commercial timing will also matter. Even if the regulatory review is successful, adoption could be gradual. Transplant centers may initially use the system selectively for higher-risk donors, longer transport distances, or cases where static cold storage is viewed as insufficient. Broader use would likely require confidence that the system improves decision-making and outcomes enough to justify integration into standard transplant workflows.
How donor heart utilization could become the real measure of success
The most important long-term question is not whether HOPE can preserve a heart for longer in selected cases. The bigger question is whether it can change donor heart utilization in routine transplant practice. If transplant teams become more confident accepting extended-criteria donor hearts, the technology could help address one of the most persistent inefficiencies in organ transplantation.
That would be a meaningful shift because donor-heart rejection is often driven by a mix of clinical caution and logistics risk. Surgeons may decline hearts because preservation time is too long, donor factors are unfavorable, or the margin for error appears too narrow. An active preservation system could alter that calculation by giving teams more time and potentially more confidence in organ quality during transport.
However, behavioral change in transplantation is difficult. Surgeons and transplant programs are judged on outcomes, and the consequences of poor graft performance are severe. A new device must therefore demonstrate not only that it works in a trial but that it can be trusted in real-world practice under time pressure, across varied procurement teams, and with different levels of institutional experience.
Manufacturing and scalability will also influence adoption. If demand grows, XVIVO will need to support reliable device availability, training, service infrastructure, and clinical education. The company’s positioning as a transplant-focused medical technology manufacturer gives it a relevant foundation, but the U.S. heart transplant market will still require disciplined commercialization.
What clinicians, regulators, and industry observers are likely to watch next
Clinicians will watch the full PRESERVE Trial dataset for subgroup performance, adverse events, individual endpoint components, preservation-time distribution, and evidence that extended preservation did not come at the expense of early or one-year outcomes. Regulators will focus on whether the clinical evidence supports the proposed indication and whether the device can be used safely and consistently across transplant centers.
Industry observers will also be watching whether XVIVO can turn regulatory progress into adoption momentum. Organ preservation has become a strategically important medtech category because transplant systems need to increase organ utilization, reduce waste, and widen access for patients who may otherwise wait too long for a suitable donor organ. Technologies that can safely expand donor pools may become increasingly important as demand for transplantation continues to exceed supply.
The PRESERVE Trial gives XVIVO a stronger story heading into U.S. regulatory review. It suggests that HOPE using the XVIVO Heart Assist Transport may support longer preservation times and could help transplant teams consider donor hearts that are currently difficult to use under static cold storage constraints. The full test will be whether the evidence is strong enough to satisfy the U.S. Food and Drug Administration, persuade clinicians, and support real-world adoption across transplant systems that move carefully for very good reasons.
