# Platform for Extended Kidney Preservation Via Subnormothermic Perfusion

> **NIH NIH R44** · BIOMEDINNOVATIONS, INC. · 2024 · $1,870,135

## Abstract

Kidney transplantation is currently the optimal renal replacement therapy due to reduced morbidity and mortality,
better quality of life, and decreased cost compared to dialysis. However, transplants remain severely limited by
a shortage of donor kidneys available for transplantation, with over 90,000 patients on the waiting list. This
imbalance in supply and demand has resulted in a strong desire to use high-risk kidney grafts from older donors
and donors after circulatory death (DCD). These high-risk kidney grafts often incur significant injury during
preservation and transportation prior to transplantation, leading to diminished graft survival. As such, high-risk
kidney grafts are discarded at high rates because of the inability to predict their function. To improve the
preservation and acceptance of high-risk kidney grafts, including DCD kidneys, investigators at the Duke Ex Vivo
Organ Lab (DEVOL) and BioMedInnovations LLC (BMI) have developed a unique subnormothermic (22-25°C,
approximately room temperature) oxygenated perfusion platform, consisting of a perfusion device and matched
“DEVOL solution”. Pilot studies using a porcine model of DCD kidney transplantation demonstrated significant
improvements in post-transplant kidney graft function versus the historical standard of care, static cold storage
(SCS).
Consistent with the NIDDK SBIR research priority “development of devices or techniques to enhance the long-
term success of kidney transplantation (e.g., techniques for kidney storage and preservation)”, this project will
generate evidence that the BMI platform provides superior performance to the current standard of care for high-
risk kidneys, namely hypothermic machine perfusion (HMP). Availability of this data would result in this
technology rapidly moving forward to commercialization.
The project includes Specific Aims to 1) optimize the engineering aspects of BMI’s platform (consisting of the
device and perfusate); 2) determine, ex-vivo, the impact of warm ischemic injury and duration of device
preservation on kidney graft injury for the BMI platform versus the current standard of care; and 3) compare the
function of high-risk kidney grafts preserved with the BMI platform versus the current standard of care using a
porcine kidney auto-transplant model.
The outcome of this project will include preclinical evidence that demonstrates that BMI’s platform is likely to
provide a meaningful advance over the current standard of care when used in humans and advance the platform
towards commercialization. This will help BMI to secure further investment, successfully engage with regulators
and ultimately, gain customer adoption that leads to improved access to kidneys for those on the transplant
waiting list.

## Key facts

- **NIH application ID:** 11013667
- **Project number:** 1R44DK139895-01A1
- **Recipient organization:** BIOMEDINNOVATIONS, INC.
- **Principal Investigator:** Andrew Serghios Barbas
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,870,135
- **Award type:** 1
- **Project period:** 2024-09-20 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11013667

## Citation

> US National Institutes of Health, RePORTER application 11013667, Platform for Extended Kidney Preservation Via Subnormothermic Perfusion (1R44DK139895-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11013667. Licensed CC0.

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