Clinical data presented at the 2025 American Society of Transplant Surgeons Winter Symposium demonstrates favorable outcomes when utilizing the Paragonix LIVERguard System compared to traditional ice storage of donor livers.1
WALTHAM, MA, January 21, 2025 - Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced today the presentation of impactful clinical data on the use of its advanced organ preservation system, LIVERguard®, in a study presented at this year’s ASTS Winter Symposium. The study compares conventional ice static cold storage to the Paragonix LIVERguard system, using real-world multi-center data collected from the GUARDIAN-Liver Registry. The analysis illustrates that advanced liver preservation technology favorably influences post-transplant outcomes, including a statistically significant 27% reduction in acute kidney injury rates (p=0.016), a potentially life-threatening post-transplant complication.1 Additional data showed clinically impactful reductions in other common post-transplant complications, marking the results of the study an important development for liver transplant centers.
The GUARDIAN-Liver data was collected from October 2022 to October 2024, consisting of 603 total patients from transplant centers across the United States. The study analyzed the impact of advanced hypothermic preservation on a propensity-matched cohort of 254 total patients (127 LIVERguard vs 127 Ice). The results of the study showed trends indicating that transplant recipients who had their donor livers stored in a Paragonix LIVERguard device experienced reductions in a variety of post-transplant complications, including numerical reductions in early allograft dysfunction (EAD) (10.5% LIVERguard vs 19% ice static cold storage , p=0.074), and a reduction in new hemodialysis post-transplant (4% LIVERguard and 7.8% ice static cold storage, p=0.37).1
Propensity Matched DBD Transplants Analysis
· 27% reduction in acute kidney injury, or AKI (p=0.016)
· 44% reduction in early allograft dysfunction, or EAD (p=0.074)
· 48% reduction in new hemodialysis post-transplant (p=0.37)
“This study indicates that patients who received livers transported using the Paragonix LIVERguard may have more favorable post-transplant outcomes compared to those whose livers were stored on ice using traditional methods,” said Dr. Kiran Dhanireddy, US Principal Investigator of the GUARDIAN-Liver study and Vice President and Chief of the TGH Transplant Institute. “Incredibly, the predicted probability of early allograft dysfunction was attenuated across all ischemic times utilizing hypothermic preservation technology, even with an average ischemic time three hours longer than the average times captured in the ice static cold storage cohort. In an era of evolving allocation policies, these findings indicate that LIVERguard preservation may allow for the extension of cold ischemic times and expansion of the donor pool, whilst mitigating the risk of post-transplant complications.”
“The findings of this groundbreaking analysis further support our mission to equip the transplantation community with every possible advantage,” said Dr. Lisa Anderson, President of Paragonix Technologies. “Currently, more than 20% of U.S. liver transplant centers rely on LIVERguard to protect donor organs during transport to the patients on their waiting lists.2 We remain committed to innovation, striving to deliver the most clinically impactful technology to support our community and their patients.”
The Paragonix LIVERguard system is an FDA-cleared medical device intended to be used to transport, store, and monitor donor livers when in transit from donor to recipient. The device uses proprietary cooling technology to regulate the temperature of the donor organ. The GUARDIAN-Liver Registry analyzes the impact of donor organ temperature on patient outcomes. For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.
References
1. Dhanireddy, et al. ASTS 2025 Presentation
2. Data on File, SRTR (www.srtr.org)
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