Clinical Study of Over 1,000 Transplant Recipients Demonstrates Improved Clinical Outcomes in Heart Transplantation with the Paragonix SherpaPak

Paragonix Technologies, Inc., a leading organ transplant company, announces that the latest clinical report of over 1,000 transplant patients studied in the GUARDIAN-Heart Registry was presented at the 2023 ISHLT Annual Meeting & Scientific Sessions. GUARDIAN clinical investigators and 21 independent transplant centers presented extensive findings in over 20 presentations throughout the conference, detailing the impact of advanced donor heart preservation and the clinical benefits that transplant recipients experienced with the use of the Paragonix SherpaPak Cardiac Transport System.

The conclusions of multiple research presentations highlighted that the use of a Paragonix SherpaPak system is associated with a reduction in common post-transplant complications, as well as an increase in survival rates. Notably, the most impactful results consistently demonstrate a significant reduction in Severe Primary Graft Dysfunction (PGD), a serious post-transplant complication. Dr. Andreas Zuckermann, a renowned cardiothoracic surgeon at the University of Vienna (Austria), also presented data at the conference showing that patients who experience Severe PGD after a heart transplant have an over 677% or almost 8 times higher risk of mortality (p=<0.001) within the span of one year, highlighting the severity of this complication on patient survival.¹

"The findings of this analysis confirm our hypothesis that Primary Graft Dysfunction, especially Severe PGD, can have a notable and potentially hazardous effect on the survival of heart transplant recipients, both in the immediate post-operative period and at the 1-year mark. It will be very interesting to evaluate longer follow-up to estimate the impact on long term survival," said Dr. Andreas Zuckermann.

During the conference, Dr. David D'Alessandro, US Principal Investigator of the GUARDIAN study, Associate Chief of Clinical Operations in Cardiac Surgery, and Associate Professor of Surgery at Massachusetts General Hospital, presented data showing that the Paragonix SherpaPak reduced the incidence of Severe PGD by 36% in a study of over 1000 patients. Further analysis revealed that the rate of reduction increased to over 50% in over 550 patients who were propensity matched based on donor characteristics.² Multiple other presentations that examined subpopulations of the GUARDIAN-Heart Registry also demonstrated a consistent trend of decreased incidence of Severe Primary Graft Dysfunction (PGD) and improved post-transplant outcomes, including:

Extended Criteria Donors³ (Donor Pool Expansion)

• 36% reduction in all post-transplant MCS (p=0.012)
• 49% reduction in newly placed ECMO/VAD post-transplant (p=0.03)
• 45% reduction in PGD (p=0.015)
• 55% reduction in Severe PGD (p=0.02)

Long Ischemic Times⁴ (Over 4 Hours Ischemic Time)

• 43% reduction in all post-transplant MCS (p=0.019)
• 53% reduction in new ECMO/VAD post-transplant (0.045)

Older Reciptents⁵ (Over 50 Years)

• 51% reduction in Severe PGD (p=0.01)
• 46% reduction in new ECMO/VAD post-transplant (p=0.01)

LVAD Patients⁶

• 61% reduction in Severe PGD (p=0.01)
• 60% reduction in new ECMO/VAD post-transplant (p=0.012)

The data was collected retrospectively from medical records of patients already transplanted before the initiation of the GUARDIAN-Heart registry, and any new patients who met the eligibility criteria. Study results indicate that the use of the Paragonix SherpaPak represents one of the very few modifiable factors available to transplant physicians to decrease the probability of Severe PGD.² The researchers discovered that in many cases, advanced organ preservation with the Paragonix SherpaPak, as opposed to ice storage, is the sole controllable variable for preventing Severe PGD.²

"After analyzing the results from 1,000 heart transplant recipients, we can now say with more confidence than ever that the Paragonix SherpaPak has proven benefits in reducing Severe PGD, which is a serious and dangerous post-surgical complication following a heart transplant," said Dr. David D'Alessandro. "The wealth of data pointing to the clinical benefit of the Paragonix SherpaPak should urge the clinical community to consider how organ preservation methodologies may impact patient outcomes."

"Our research continues to provide key insights into how transplant surgeons can utilize the Paragonix SherpaPak system to improve the standard of care," said Dr. Lisa Anderson, CEO and President of Paragonix Technologies. "Now, in the United States more than 40% of heart transplant centers and a large number in Europe have adopted this advanced technology with the goal to improve the quality of life that heart transplant patients deserve to experience. At Paragonix, our relentless efforts to advance clinical research in donor organ preservation are driven by our commitment to improving the lives of both current and future organ transplant patients."

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.

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1. Zuckermann et al., ISHLT Presentation 2023, Data on file
2. D'Alessandro et al., ISHLT Presentation 2023, Data on file
3. Moayedifar et al., ISHLT Presentation 2023, Data on file
4. Takeda et al., ISHLT Presentation 2023, Data on file
5. Copeland et al., ISHLT Presentation 2023, Data on file
6. Lerman et al., ACC Moderated Poster 2023, Data on file

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 21 sites on 1013 patients (453 ice transports and 560 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.