Study Model
DCD porcine auto-transplant
Warm Ischemia
30 minutes
Comparator
OrganBank vs. LifePort
Primary Endpoint
Delayed graft function
In a preclinical porcine auto transplant study, the OrganBank Kidney platform was associated with more consistent early graft function and a reduction in delayed graft function compared with the standard-of-care hypothermic machine preservation1,2.
The study used a donation after circulatory death (DCD) porcine kidney auto-transplant model with 30 minutes of induced warm ischemia, designed to directly compare preservation approaches. 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.
In this preclinical model:
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 organ viability data 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 providing viability 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.
This study demonstrates that OrganBank Kidney provided superior preservation outcomes compared to the LifePort device in a porcine kidney auto-transplantation model.
Using a survival-based definition of delayed graft function, the OrganBank Kidney group achieved 0% DGF incidence compared to 40% in the LifePort group.
Secondary outcome analysis further supports these findings:
All predefined acceptance criteria were fully met. No adverse events attributable to OrganBank Kidney preservation were observed. Grafts preserved using the OrganBank system consistently met or outperformed control benchmarks across clinical and biochemical outcomes.
These results provide a compelling preclinical rationale for further translational evaluation of the OrganBank Kidney system.
Reflects the FDA's recognition of the unmet need in kidney transplantation.
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