Organ preservation company enhances GUARDIAN-Heart transplant study to explore impact of advanced preservation on organ rejection and hospital readmission rates

WALTHAM, MA. August 20, 2024 - Paragonix Technologies, a leading organ transplant company, has announced the expansion of its GUARDIAN Registry with the introduction of a new sub-study in the cardiac branch of research. This initiative will further enhance the understanding and management of post-transplant rejection, with a particular focus on molecular diagnostics. For the first time, this large scale data collection effort connects the major data sets in pre, peri and post transplantation: donor organ data, preservation data, post-operative outcomes, survival and – uniquely – post-transplant rejection data.

“This GUARDIAN-Heart sub-study will add data that may prove pivotal for the future of heart transplants,” said Dr. Kiran Khush, Professor of Medicine, Director of Heart Transplant Research, and transplant cardiologist at Stanford Health Care. “Understanding the nuances of post-transplant recovery and the factors influencing patient outcomes will enable us to tailor treatments more effectively. Our goal is to reduce complications, lower readmission rates, and ultimately ensure that transplant patients have the best possible quality of life.”

The GUARDIAN study is the world’s largest post-market, observational registry of over 3,500 organ transplant recipient patients whose donor organs were preserved and transported using Paragonix Advanced Organ Preservation Systems. The study has collected millions of data points on clinical outcomes, post-transplant complications, and patient survival to help enhance the understanding and management of organ transplant care.

The addition of a molecular diagnostics sub-study will allow GUARDIAN investigators to gather comprehensive data on rejection and readmission rates captured throughout the subsequent 12-month period following a heart transplant. Expanding upon extensive data acquired from the pre- and post-operative to discharge phase, this study will now encompass the crucial post-discharge period, providing patient insights over a full year. The data collected will encompass biopsies, cell-free DNA (cfDNA), gene expression profiling (GEP), Molecular Microscope Diagnostic System (MMDx), renal replacement therapy (RRT), and readmission interventions.

“We thank GUARDIAN Clinical Investigators and our transplant partners for initiating this new study to provide deeper insights into the long-term outcomes of transplant patients,” said Dr. Lisa Anderson, CEO of Paragonix. “The planned analyses will provide data to better understand the impact of preservation on organ rejection and improve post-transplant care for patients.”

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