Clinical data presented at the 2025 World Transplant Congress demonstrates favorable outcomes when utilizing the Paragonix LIVERguard System compared to traditional ice storage of donor livers¹ 

WALTHAM, MA, August 6, 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 World Transplant Congress. The study compared conventional ice static cold storage to the Paragonix LIVERguard system, using real-world multi-center data collected from the GUARDIAN-Liver Registry. The analysis illustrated that advanced donor liver preservation technology favorably reduced the incidence of early post-transplant outcomes, such as early allograft dysfunction and acute kidney injury, despite facing longer recovery distances and cold ischemic time compared to the ice cohort.

The GUARDIAN-Liver data was collected from October 2022 to March 2025, consisting of 898 total patients from transplant centers across the United States. The study analyzed the impact of advanced hypothermic preservation on a propensity-matched cohort of 410 total patients (205 LIVERguard vs 205 Ice). Notably, the baseline characteristics of the cohorts were similarly matched in all aspects except distance traveled, where the LIVERguard cohort experienced greater overall distances (280+314 nautical miles LIVERguard vs 195+269 Ice, p=0.003.) Despite facing significantly broader geographic transit, the LIVERguard cohort still demonstrated a 51% reduction in early allograft dysfunction (26.0% vs 12.5%, p<0.001).¹

The research presented throughout the conference strongly indicates that there is no cold ischemic time where ice provides benefit over controlled hypothermic preservation with LIVERguard. The LIVERguard System may extend cold ischemic times while reducing the risk of early allograft dysfunction.

Dr. Kiran Dhanireddy, US Principal Investigator of the GUARDIAN-Liver study and Vice President and Chief of the TGH Transplant Institute, presented his findings at the conference. “The accumulation of clinical data in the GUARDIAN-Liver Registry is presenting more and more evidence against the use of ice storage,” he said. “The LIVERguard System is proving to be a flexible and effective means to provide controlled hypothermic preservation in the modern era as allocation strategies evolve and transplant programs seek to safely grow their program.”

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.

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