Paragonix Shares Positive LIVERguard System Clinical Data

Advanced liver preservation technology leads to better post-transplant outcomes than conventional ice static cold storage, according to a study of Paragonix Technologies’ advanced organ preservation system, LIVERguard. The trial compares conventional 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. 

“The findings of this analysis further support our mission to equip the transplantation community with every possible advantage,” Paragonix Technologies President Dr. Lisa Anderson said. “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 GUARDIAN-Liver data was collected from October 2022 to October 2024, consisting of 603 total patients from U.S. transplant centers. The study analyzed the impact of advanced hypothermic preservation on a propensity-matched cohort of 254 total patients (127 LIVERguard vs 127 Ice). The study results showed trends indicating that transplant recipients whose donor livers were stored in a Paragonix LIVERguard device experienced fewer post-transplant complications, including reductions in early allograft dysfunction (EAD) (10.5% LIVERguard vs. 19% ice static cold storage,  p=0.074), and not as many hemodialysis post-transplant (4% LIVERguard vs. 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,” stated Dr. Kiran Dhanireddy, U.S. principal investigator of the GUARDIAN-Liver study and vice president/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 Paragonix LIVERguard system is a U.S. Food and Drug Administration (FDA)-cleared medical device 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.

Paragonix Technologies is a 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. Its 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 the company’s digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution.

References
¹ Dhanireddy, et al. ASTS 2025 Presentation
² Data on File, SRTR (www.srtr.org)