Paragonix Technologies, Inc. Announces FDA Clearance and U.S. Launch of the Paragonix SherpaPak™ Pancreas Transport System

CAMBRIDGE, Mass.–Paragonix Technologies, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Paragonix SherpaPak™ Pancreas Transport System (PTS)1. Starting immediately, the Paragonix SherpaPak™ PTS will be commercially available to pancreas transplant centers and Organ Procurement Organizations. The Paragonix SherpaPak PTS provides unprecedented thermal and physical protection to the donor pancreas during transport from donor to recipient patients.

“This is an innovation milestone in the preservation and transportation of the human pancreas,” said Matthew Cooper, MD, Director of Kidney and Pancreas Transplantation at the MedStar Georgetown Transplant Institute (MGTI) and Professor of Surgery at Georgetown University School of Medicine. “The donor pancreas is highly susceptible to cold and compression injury during transport. Technologies that improve on the current method of storing a pancreas in an ice cooler are desperately needed. We look forward to evaluation the Paragonix SherpaPak Pancreas Transport System for advanced donor pancreas preservation.”

“We are delighted to provide yet another tool for the transplant community to provide every possible advantage to transplant recipients. The Paragonix SherpaPak PTS is the first pancreas preservation device cleared by the FDA and we are thrilled to have reached this critical market clearance,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “The most recent U.S. national data available for 2019 suggests that nearly 1,000 transplants took place in the U.S. consisting of either pancreas or simultaneous pancreas plus kidney transplant procedures. We believe the Paragonix SherpaPak™ PTS will be highly impactful for both single-pancreas transplantation as well as for combined pancreas plus kidney transplantation, for which we offer our FDA-cleared Paragonix SherpaPak™ Kidney Transport System (KTS)2 for advanced kidney preservation.”

About Pancreas and Pancreas/Kidney Transplantation 
Successful pancreas transplantation has been demonstrated to be efficacious in significantly improving the quality of life of people with diabetes, primarily by eliminating the need for exogenous insulin, frequent daily blood glucose measurements and many of the dietary restrictions imposed by the disease. Transplantation can also eliminate the acute complications commonly experienced by people with type 1 diabetes such as hypoglycemia and hyperglycemia.3 According to the American Diabetes Association, the total costs of diagnosed diabetes have risen to $327 billion in 2017 from $245 billion in 2012, when the cost was last examined.4 Diabetes mellitus is one of the leading causes of chronic kidney disease (CKD). In patients with advanced diabetic kidney disease, kidney transplantation (KT) with or without a pancreas transplant is the treatment of choice.5 This applies to simultaneous pancreas-kidney transplantation or pancreas transplantation after KT compared to KT alone (either living donor or deceased). Pancreas and kidney transplantation seems to be the treatment of choice for most type 1 diabetic and selected type 2 diabetic patients.6

About the MedStar Georgetown Transplant Institute 
MedStar Georgetown Transplant Institute performs more living donor kidney transplants than any other healthcare institution in the Washington D.C. metropolitan area. It is also recognized as a national leader in kidney exchange and the management of recipients and donors who are incompatible. Only a handful of transplant centers in the United States offer this option to their patients. For more information, visit: MedStarGeorgetown.org/LivingDonor.

About Paragonix Technologies, Inc. 
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. The Paragonix SherpaPak™ CTS is the only commercially available FDA-cleared and CE-marked transport device for heart transportation. Paragonix is also developing transport devices for the lung, liver, pancreas and kidneys designed to improve donor organ quality and extending donor organ transport time.

1 The SherpaPak™ Organ Transport product line is protected by patents, both issued and pending 
2 Paragonix SherpaPak Kidney Transport System (KTS) received FDA clearance November, 2014 
3 Diabetes Care 2003 Jan; 26(suppl 1): s120-s120. 
4 https://www.diabetes.org/resources/statistics/cost-diabetes 
5 J Clin Med. 2015 Jun; 4(6): 1269–1280. 
6 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4484999/