Paragonix SherpaPak Recognized for Maximizing Access to the Donor Pool in New Clinical Study

WALTHAM, Mass.–(BUSINESS WIRE)–Paragonix Technologies, a pioneer in organ transplant solutions, is proud to announce the publication of new groundbreaking data reflecting the clinical impact of its flagship advanced preservation device, the Paragonix SherpaPak Cardiac Transport System (CTS), to protect and monitor donor hearts from extended criteria donors. In organ transplantation, an extended criteria donor is defined as having perceived risk factors linked to poor subsequent outcomes, for example, those with age >55 or ischemic times exceeding 4 hours, which sometimes leads to rejection of the donor organ. The use of extended criteria donor organs can increase the availability of life-saving transplantable organs, proving to be a valuable solution to those on the waitlist in need of an organ transplant.

“These findings demonstrate that the SherpaPak can be safely utilized to expand the donor pool to keep pace with the demand for heart transplants.”

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The Paragonix SherpaPak CTS is a static hypothermic preservation device intended to protect the donor heart during transit, standardizing the internal environment to maintain a recommended thermal range above freezing, unlike traditionally used ice-cold storage. Published in the esteemed Journal of Heart and Lung Transplantation, this study compared the effectiveness of ice-cold storage against the Paragonix SherpaPak CTS, assessing the post-transplant outcomes of recipients who received an extended criteria donor heart. In the recipient group which utilized the Paragonix SherpaPak, the analysis found a significant reduction of 43% in Primary Graft Dysfunction (PGD), a term used to describe the early dysfunction or failure of the transplanted organ. The results also showed a significant reduction of 55% in Severe PGD, a more severe complication occurring within the first 24 hours post-transplant, shown to significantly impact long-term survival of heart transplant recipients.

“The study finds the Paragonix SherpaPak Cardiac Transport System provides a clinically effective solution to safely increase donor heart utilization. The results provide strong support for the utilization of Paragonix advanced organ preservation technologies with extended criteria donor organs,” said Dr. Andreas Zuckermann, Director for Cardiac Transplantation at the Medical University of Vienna (Austria). “These findings demonstrate that the SherpaPak can be safely utilized to expand the donor pool to keep pace with the demand for heart transplants.”

The key findings of this study included:

• Significant reduction in post-transplant complications: 13.9% of patients who received an extended criteria donor heart preserved on conventional ice storage reported Severe PGD, compared to 6.2% utilizing the Paragonix SherpaPak CTS (p=0.022).
• Significant reductions in all post-transplant mechanical circulatory support (37% reduction, p=0.012)
• Significant reduction in newly placed ECMO/VAD post-transplant (49% reduction, p=0.03) when utilizing the Paragonix SherpaPak CTS
• 92.9% 1-Year Survival in the Paragonix SherpaPak CTS cohort

The study consisted of 330 patients receiving extended criteria donor hearts, and the data was collected from fifteen transplant centers across the United States from October 2015 to January 2023 as part of the GUARDIAN-Heart Registry.

“At the end of 2023, over 3,000 patients on the transplant waitlist were still in need of a heart transplant,” said Dr. Lisa Anderson, CEO and President of Paragonix Technologies. “We strive to provide new medical technology to enable transplant physicians to safely expand the donor pool and ultimately increase the number of life-saving heart transplants for all patients in need.”

About Paragonix Technologies

Paragonix Technologies is a leading 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. Our 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 our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonix.com.

Disclaimer

Comparison of Paragonix SherpaPak to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 15 sites on 330 patients (137 ice transports and 193 Paragonix SherpaPak CTS transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.

Paragonix SherpaPak^® Indications for Use

The Paragonix SherpaPak® Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.

The intended organ storage time for the Paragonix SherpaPak™ Cardiac Transport System is up to 4 hours. Donor hearts 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.

References
1. Moayedifar et al., JHLT 2023, Data on file

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