GUARDIAN-Lung Registry data presented at the 44th ISHLT Annual Meeting & Scientific Sessions demonstrates the LUNGguard Donor Lung Preservation System may significantly attenuate the risks associated with ischemic time on post-operative complications.

Paragonix Technologies, Inc., a pioneer in organ transplant technologies and services, presented impactful clinical data on the use of its Advanced Organ Preservation system, LUNGguard^®, in the largest real-world multi-center study presented at the 44th ISHLT Annual Meeting and Scientific Sessions – one of the largest international conferences focused on advanced treatment for end-stage heart and lung disease. The study compares conventional ice storage to the Paragonix LUNGguard system. 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.

The GUARDIAN-Lung data was collected from August 2018 through January 2024, including 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:

• 38% reduction of Primary Graft Dysfunction 3 (PGD 3) at 24 hours
  • (12.7% LUNGguard vs. 20.5% Ice, p = 0.024)¹
• 39% reduction of Extracorporeal Membrane Oxygenation (ECMO) post-transplant
  • (11.6% LUNGguard vs. 18.9% Ice, p = 0.027)¹
• 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

“This is the largest real-world study on the static, cold-storage preservation of donor lungs,” said Dr. John Haney, a US 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.”

The Paragonix LUNGguard™ system is an FDA-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, it was recorded that 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 Statement². 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,” said Dr. Lisa Anderson, CEO and President of Paragonix Technologies. “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. For more information, visit paragonix.com

LUNGguard^® Donor Lung Preservation System Indications for Use

The Paragonix LUNGguard™ (LUNGguard™) is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for LUNGguard™ is up to 8 hours.

Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

About Paragonix Technologies

Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to 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. For more information, visit www.paragonix.com.

Disclaimer

Comparison of Paragonix LUNGguard 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 9 sites on 797 patients (389 ice transports and 408 Paragonix LUNGguard 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. Haney, et al. ISHLT 2024 Presentation

2. Copeland et al., ISHLT Consensus Statement, 2020

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