WALTHAM, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) — 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.
About Paragonix Technologies
Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. Paragonix Technologies provides Advanced Organ Preservation (“AOP”) devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonix.com.
About Getinge
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile processing and life science. Getinge employs approximately 12,000 people worldwide and the products are sold in more than 135 countries.
Disclaimer
Comparison of Paragonix LIVERguard to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04930289) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 10 sites on 898 patients (483 ice transports and 415 Paragonix LIVERguard transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.
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References
1. Dhanireddy, et al. WTC 2025 Presentation
2. Data on File, SRTR (www.srtr.org)
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/37f3bd13-5ad1-4885-8afd-bf7d55162678