BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced publication of "Innovate Cold Storage Of Donor Organs Using The Paragonix Sherpa Pak Devices"1 by investigators from the Transplantation Biology Research Center, Department of Surgery, Massachusetts General Hospital and Harvard Medical School (Boston) and the Department of Cardiac Surgery, Ludwig-Maximilians-University (Munich, Germany).
Sebastian Michel, MD, first author of the study on faculty at the Department of Cardiac Surgery, Ludwig-Maximilians-University, commented, “We are delighted to present data regarding a new, innovative organ preservation technology. This study focused on testing the robustness of the single-use Paragonix Sherpa Pak™ organ transport device, which is designed to maintain constant organ preservation temperatures between 4°C to 8°C. In several evaluations, Sherpa Pak™ was challenged to extremely high and low external temperatures during organ storage. Our data demonstrated that internal organ preservation temperatures were maintained within the design range. We further concluded that the Paragonix Sherpa Pak™ device may decrease cold injury of donor organs undergoing transport and preservation by maintaining the temperature consistently between 4°C to 8°C, thereby potentially decreasing early primary graft failure after organ transplantation."
Bill Edelman, CEO and Chairman, for Paragonix commented, “The Paragonix Sherpa Pak™ devices for kidney and heart preservation are an important step in improving donor organ transportation. We believe that improving the utilization of donated organs is critical to patients who are desperate for this precious commodity.”
Paragonix previously announced on February 9, 2015, Innovative Tracking Technology For Real-Time, National Location Tracking of Donor Organs.
Paragonix previously announced on December 2, 2014, clearance of two 510(k) Premarket Notifications by the US Food and Drug Administration, allowing the Paragonix Sherpa Pak Transport Systems to be combined and distributed with any FDA-cleared, commercially-available preservation solution.
Paragonix previously announced on Nov 17, 2014, Receipt of ISO 13485:2003 Certification for the Paragonix Sherpa Organ Storage and Transport Systems.
Paragonix previously announced on Nov 3, 2014, filing of two 510(k) FDA Pre-Market Notifications to combine the Paragonix Sherpa Pak Cardiac and Kidney Transport Systems with any effective organ preservation solution currently marketed under 510(k) Pre-market Clearance.
Paragonix previously announced on Oct 27, 2014, joining of David D’Alessandro, MD, as Medical Director for Paragonix.
About Ludwig-Maximilians-University (Munich, Germany)
LMU is recognized as one of Europe's premier academic and research institutions. Since being founded in 1472, LMU has attracted inspired scholars and talented students from all over the world, keeping the University at the nexus of ideas that challenge and change our complex world.
About Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $760 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine.
About the Paragonix Sherpa™ Portfolio of Organ Transport Technologies
Currently, the availability of organs for transplantation is governed by the “ischemic time”, which is the elapsed time from organ donation to recipient implantation. The Paragonix Sherpa™ is designed for use in conjunction with any of currently available organ preservation solutions. Paragonix Sherpa™ is fully disposable, eliminating problems associated with maintenance, device transport and contamination. Paragonix Sherpa™ is intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for implantation. The Sherpa Pak™ CTS is intended for transport of hearts and the Sherpa Pak™ Kidney Transport System is intended for transport of kidneys within the time frame currently considered as routine medical practice. The Sherpa Perfusion™ CTS is intended to be used for hypothermic oxygenated perfusion preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.
About Paragonix Technologies, Inc.
Based in Braintree, Massachusetts, and founded in 2010, Paragonix Technologies, Inc., is a privately held medical device company innovating the Paragonix Sherpa™, a novel, single-use organ preservation device. Paragonix has exclusively licensed University of Texas Health Science Center San Antonio intellectual property from the Office of Technology Transfer and Commercialization. Paragonix has established a pipeline of donor organ transport devices that addresses the current donor organ shortage by maximizing donor organ utilization and improving donor organ quality throughout the entire United States.
1 Heart, Lung and Vessels; (in press) - http://www.heartlungandvessels.org