Novel portable hypothermic perfusion technology facilitates the preservation and transport of perfused donor kidneys throughout journey from donor to recipient

WALTHAM, MA. January 28, 2024 - Paragonix Technologies. a pioneer in organ transplant technologies and organ procurement services, announced today the completion of the world’s first-in-human cases utilizing its FDA-cleared KidneyVault™ Portable Renal Perfusion System, marking a new chapter in kidney transplant preservation. These landmark cases included the successful transport of four donor kidneys to four separate medical institutions across the nation in a 24-hour period last December. The successful transplants were made possible through the support of leading OPOs (organ procurement organizations), including, LifeGift of Houston, Texas.

The KidneyVault Portable Renal Perfusion System received FDA clearance in October of 2024. The lightweight device is designed for convenient end-to-end hypothermic perfusion, offering new levels of standardization that aligns with kidney allocation workflow of all involved parties. OPOs and transplant centers can remotely monitor the device in real-time with a data-driven dashboard that shares perfusion parameters, temperature conditions, and other critical data at all times. The combination of portable perfusion technology and real-time data insights offer OPOs and transplant centers a comprehensive solution currently unavailable on the market.

OPOs like LifeGift leverage advanced technologies such as the KidneyVault System to improve post-transplant outcomes and increase national access to the limited pool of available donations. Kidney donation represents a striking demand of nearly 90,000 total individuals listed in need of a donation – 86% of the 2024 transplant waiting list. At the end of November 2024, just over 25,000 kidney transplantations were able to be performed.

“Hypothermic perfusion increases the availability of high-quality donor kidneys nationwide,” said Yolanda Becker, MD, Vice President and Chief Medical Officer at LifeGift. “However, historically, it was not always feasible to deliver every kidney on pump due to the distances traveled increasing cold ischemic times. LifeGift is now at the forefront of portable perfusion technologies that allow us to transport kidneys greater distances, by ground or commercial air, using a single controlled device from end-to-end. This hands-off solution provides the flexibility to deliver a kidney on pump to transplant centers."

The national kidney allocation policy was revised in recent years to enable broader organ distribution strategies and increase the overall volume of transplant offers. Placement efforts have increased dramatically for each kidney, resulting in more complex logistics and extended transport times in which the kidney remains outside of the body, a concept known as cold ischemia time. Notably, the clinical community has come to rely on hypothermic machine perfusion devices to compensate for longer cold ischemia times by pumping a perfusate solution through the kidney to sustain viability in a controlled environment.

“LifeGift is proud to be among the first to adopt this innovative technology,” said Kevin A. Myer, MSHA, LifeGift President & CEO. “LifeGift is committed to clinical research and new technologies that will help save lives today and in the future. The device allows us to provide our transplant center partners with recovered kidneys that have been monitored throughout the journey, regardless of the transportation mode. The portability of the system will facilitate broader sharing of machine-perfused kidneys and will result in greater use of recovered kidneys for transplant.”

The successful first-in-human use of the KidneyVault System marks a major milestone in Paragonix Technologies’ mission to transform the standard of care in transplantation. Notably, Paragonix now offers advanced preservation technologies across all solid organ transplantation – a world first. “We are fully committed to ensuring every patient has the best possible chance at life,” said Lisa Anderson, PhD, President of Paragonix Technologies. “This achievement highlights the potential of this one-of-a kind portable perfusion technology and sets a new standard for safety, reliability, and efficiency.”

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About LifeGift

About LifeGift - LifeGift is a nonprofit, 501(c)(3) health services organization. As the organ procurement organization (OPO) for North, Southeast and West Texas, we partner with more than 200 hospitals across 109 counties to save and heal lives. LifeGift is a founding member of Donate Life Texas, the organization that manages the organ, eye and tissue donor registry. For more information, please visit LifeGift.org.

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