Paragonix Technologies Inc. is sharing positive clinical data on the use of its Advanced Organ Preservation system, LUNGguard, from the largest real-world multi-center study that compared the product to conventional ice storage. The analysis revealed that advanced lung preservation technology with the Paragonix LUNGguard favorably influences post-transplant outcomes, including reductions in primary graft dysfunction, the use of invasive MCS interventions, and improvement in renal function.

“This is the largest real-world study on the static, cold-storage preservation of donor lungs,” said Dr. John Haney, a U.S. principal investigator of the GUARDIAN-Lung study and chair of Cardiothoracic Surgery at Mayo Clinic. “The results indicate that stable, moderate hypothermic storage has an impact beyond the window of time the donor lungs are transported and is associated with a reduction in some of the most common post-operative complications with which thoracic teams have traditionally contended.”
 
GUARDIAN-Lung data was collected from August 2018 through January 2024, encompassing 797 patients (389 ice storage patients, 408 LUNGguard patients), of which 259 subjects were identified as statistical matches based on a propensity matching methodology. Investigators discovered notable statistically significant improvements in the controlled hypothermic preservation group, including:

• A 38% reduction of Primary Graft Dysfunction 3 (PGD 3) at 24 hours‍ — (12.7% LUNGguard vs. 20.5% Ice, p = 0.024)¹
• A 39% reduction of Extracorporeal Membrane Oxygenation (ECMO) post-transplant — (11.6% LUNGguard vs. 18.9% Ice, p = 0.027)¹
• A 51% reduction in need for dialysis at discharge — (5.5% LUNGguard vs. 11.2% Ice, p = 0.025)¹

Further, a numerical reduction primary graft dysfunction at 72 hours, an indication of severe post-transplant complications, was also observed in the LUNGguard group (9.7% LUNGguard vs. 15.4% Ice, p = 0.063).¹
 
The Paragonix LUNGguard system is a U.S. Food and Drug Administration-cleared and CE-marked medical device intended to be used to transport, preserve, and monitor donor lungs when in transit from donor to recipient. The device uses proprietary cooling technology to monitor and record the temperature of the donor organ at all times of transport. Of the propensity matched cases included in the study, the 259 LUNGguard System cases averaged a range of 6.1°C ± 2.1°C, a thermal range consistent with the recommended clinical guidelines presented by the ISHLT Consensus Statement.² The 259 ice storage cases were unable to capture temperature data, and investigators noted that ice storage is empirically 0ºC.
 
“Our company firmly believes in the importance of equipping clinical teams with real-time data, including accurate temperature and location, that they can utilize in daily practice,” Paragonix Technologies President/CEO Dr. Lisa Anderson said. “The positive results of our research continues to highlight how controlled hypothermic preservation technology is reshaping the real-world standard of lung transportation.”
 
The GUARDIAN-Lung Registry analyzes the impact of advanced lung preservation protocols on patient outcomes. 

Paragonix Technologies develops, manufactures, and has established a novel approach to organ preservation that represents a significant improvement over the traditional standard of care. Paragonix Advanced Organ Preservation devices combine clinically-proven, stable cooling techniques with digital tracking and monitoring technologies to provide clinicians complete control and oversight throughout the donor organ journey. The clinical impact of Paragonix preservation technology is reinforced by the GUARDIAN clinical registries, the largest database of organ preservation data in the world that analyzes post-transplant outcomes in transplant recipients. 
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References
¹ Haney, et al. ISHLT 2024 Presentation
² Copeland et al., ISHLT Consensus Statement, 2020