Increased participation in the GUARDIAN-Liver Clinical registry follows in the footsteps of the GUARDIAN-Heart and GUARDIAN-Lung, expanding clinical research in Advanced Organ Preservation

Paragonix Technologies, the leading hypothermic organ preservation provider, announced today its expanded enrollment in its GUARDIAN series of clinical registries aimed at investigating the impact of organ preservation on clinical outcomes in donor organ transplant.

Paragonix FDA cleared hypothermic organ preservation devices for donor hearts, lungs and livers provide a sterile and temperature-controlled preservation environment for organs transported between operating rooms and serves as an alternative to traditional ice transportation. The cooling technology employed by Paragonix Organ Preservation systems ensures thermal protection for up to 40 hours, while providing a rigid and protective structure for physical safety. The devices work with a state-of-the-art app that connects to the Paragonix devices via Bluetooth for on-the-go monitoring, vital for long-distance travel.

Duke University Hospital, which is using Paragonix Technologies devices, will also become the first transplant center to enroll patients in the GUARDIAN registry for all three organs. “Participation in these types of clinical studies provide us the opportunity to explore the potential of new technologies,” said Dr. John C. Haney, Director, Thoracic Surgery Residency Programs and Assistant Professor of Surgery at Duke University School of Medicine.

The GUARDIAN-Lung registry was established in 2021 and is the largest registry studying clinical outcomes in lung transplantation based on advanced lung preservation. Results of the GUARDIAN-Lung registry were recently presented at the 2022 International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting. Dr. Matthew Hartwig, Associate Professor of Surgery at Duke University School of Medicine, presented the first report, stating “Early results from the GUARDIAN-Lung registry demonstrates safe and reliable advanced static cold storage for donor lungs.”

Additionally at ISHLT 2022, Paragonix presented the results of a groundbreaking US Multi Center 1-year Transplant Survival Analysis of the GUARDIAN-Heart Registry that included 569 adult patients who received heart transplants between October 2015 and January 2022. The analysis showed a statistically significant 72% reduction (p=0.005) in Severe Primary Graft Dysfunction (PGD) rates.^1,2 The one-year survival rate in patients where traditional cold storage was used was 88.7%.¹ In contrast, the one-year survival rate in patients where the SherpaPak was used was 96.4%. This finding represented an 8.7% increase (p=0.03) in one-year survival when using the SherpaPak for donor heart preservation.¹

“Our team at Paragonix works toward the common goal of providing donor organs and transplant recipients every possible advantage to give them a second chance at a healthy and full life,” said Lisa Anderson, Ph.D., Founder, President, and CEO of Paragonix Technologies.

For more information about Paragonix, visit www.paragonix.com.

About Paragonix Technologies

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix is a leading provider of FDA cleared and CE marked transport devices for organ preservation.

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References

1. Leacche et al., ISHLT Presentation 2022, Data on file

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