- Delayed graft function occurred in 40% of kidneys preserved using hypothermic machine preservation
BMI OrganBank recently presented new preclinical data at the American Society of Transplant Surgeons (ASTS) Winter Symposium evaluating its OrganBank Kidney platform in a controlled, head-to-head transplant model. In this study, the OrganBank Kidney platform was associated with more consistent early graft function and a meaningful reduction in delayed graft function compared with hypothermic machine preservation, the current standard of care.
These data reinforce BMI OrganBank’s mission to move organ preservation beyond passive storage toward an active, informative approach—one that preserves organ physiology, supports functional assessment, and improves confidence in transplant decision-making.
The data were presented by Nader Abraham, MD, Vice President of Research at BMI OrganBank and a Duke University transplant surgery resident, during the ASTS Winter Symposium.
The study used an established porcine kidney auto-transplant model, designed to directly compare preservation approaches under controlled conditions. Kidneys were preserved either using hypothermic machine preservation or using room-temperature machine perfusion with the OrganBank Kidney platform, then transplanted and evaluated for early graft performance.
This head-to-head design was selected to reflect real-world clinical preservation workflows and to generate data relevant to regulatory and clinical evaluation.
No delayed graft function (0%) was observed in kidneys preserved using OrganBank Kidney
Kidneys preserved with OrganBank Kidney demonstrated more consistent early graft performance
Delayed graft function—defined as inadequate kidney function immediately following transplant—remains a persistent challenge in kidney transplantation and is associated with longer hospital stays, increased healthcare costs, and poorer long-term outcomes. Reducing DGF is a key unmet need, particularly in higher-risk donor populations.
Conventional hypothermic preservation slows metabolism but limits physiologic activity and functional insight during transport. As a result, transplant teams often must make high-stakes decisions with limited real-time information about organ quality.
The OrganBank Kidney platform is designed to preserve kidneys at room-temperature using an oxygenated, acellular solution rather than blood, with the goal of maintaining active metabolism during preservation. This approach is intended to better support early graft function while opening the door to more informative assessment prior to transplant.
Beyond preservation alone, BMI OrganBank is developing its platform to support real-time functional assessment, enabling transplant teams to better understand how an organ is performing during the preservation window—not just after implantation.
These findings built on prior preclinical evidence and supported the FDA Breakthrough Device Designation granted to BMI OrganBank’s kidney preservation technology.
Breakthrough Device Designation is intended to accelerate the development and review of technologies that may provide more effective treatment for life-threatening or irreversibly debilitating conditions. In this case, the designation reflects the FDA’s recognition of the unmet need in kidney transplantation and the potential of BMI OrganBank’s approach to address it.
BMI OrganBank plans to initiate a pivotal clinical study for OrganBank Kidney later this year, advancing the platform toward clinical evaluation.
OrganBank Kidney is a portable organ preservation and assessment platform designed to integrate with existing transplant workflows.
Key design goals include:
OrganBank Kidney is investigational and is not yet approved for clinical use.
The data presented at ASTS represent an important milestone for BMI OrganBank as it progresses from preclinical validation toward clinical evaluation. By focusing on active preservation, physiologic insight, and confidence in decision-making, the company aims to expand the number of viable donor kidneys and improve outcomes across the transplant ecosystem.
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