BRAINTREE, Mass.--(EON: Enhanced Online News)--Paragonix Technologies, Inc., announced today that it has entered into an exclusive distribution agreement with Bio Instruements, LLC, to market Paragonix Technologies’ SherpaPak™ Cardiac and Kidney Transport Systems, innovative static hypothermic preservation and transport devices for donor organs in leading transplant centers in the Midwestern United States.
“We are excited for Bio Instruments to join our expanding SherpaPak™ distributor network. On a national basis we are seeing tremendous market response to the SherpaPak™ Cardiac and Kidney Transport Systems.”
William Edelman, Chairman & CEO of Paragonix Technologies commented, “We are excited for Bio Instruments to join our expanding SherpaPak™ distributor network. On a national basis we are seeing tremendous market response to the SherpaPak™ Cardiac and Kidney Transport Systems.” Mr. Edelman continued, “SherpaPak™ provides best-in-class donor organ management solutions for safe and reliable preservation and transport of donor hearts and kidneys. In November 2016, we engaged in an exclusive distribution agreement with Pacific West Medical Sales. We are adding distribution capability to our growing channel and look to have additional announcements in the near future. The Paragonix SherpaPak™ 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 in end-stage organ failure who are desperate for this precious commodity.”
Paragonix previously announced November 9, 2016 an exclusive distribution agreement with Pacific West Medical Sales for Paragonix SherpaPak™ Cardiac and Kidney Transport Systems in California
Paragonix previously announced June 29, 2016 a Product Supply Agreement with Waters Medical Systems LLC, for Waters IGL and Celsior® Cold Storage Solutions for Use With the SherpaPak™ Kidney Transport System and SherpaPak™ Cardiac Transport System
Paragonix and Essential Pharmaceuticals LLC previously announced June 28, 2016, a Product Supply Agreement for Custodiol® HTK Organ Preservation Solution for Use With the SherpaPak™ Cardiac Transport System and SherpaPak™ Kidney Transport System
Paragonix previously announced June 6, 2016, Presentation of the SherpaPak™ Cardiac Transport System during the 2016 American Transplant Congress June 11 - 15, 2016 in Boston, MA
Paragonix previously announced on July 23, 2015, Publication of “Innovative Cold Storage Of Donor Organs Using The Paragonix SherpaPak™ Devices"1
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 Bio Instruments, LLC
Bio Instruments, LLC was founded in 1978. The Company represents the upper Midwest specializing in products for Cardiac, Vascular, and Thoracic procedures.
About the Paragonix SherpaPak™ and SherpaPerfusion™ Cardiac Transport
Currently, the availability of cardiac transplantation is governed by the “ischemic time”, that being, the elapsed time from heart donation to recipient implantation. According to The International Society Of Heart and Lung Transplantation (“ISHLT”) guidelines2 for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours3,4, limiting the distance available to transport a donor heart. Paragonix SherpaPak™ Cardiac Transport System is fully disposable, eliminating problems associated with maintenance, device transport and contamination. The Paragonix SherpaPerfusion™ Cardiac Transport System combines innovative oxygenated perfusion of organs and safe organ storage with the ultimate goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts.
About Paragonix Technologies, Inc.
Based in Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix SherpaPak™ and SherpaPerfusion™ Cardiac Transport System, a novel, single-use organ preservation device to improve donor organ quality. Paragonix has established a pipeline of donor organ transport devices that address the current donor organ shortage by maximizing donor organ utilization, improving donor organ quality and extending donor organ transport throughout the entire United States.
1 Michel et al. Heart, Lung and Vessels; 2015;7(3):246-55
2 ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)
3 J Heart Lung Transplant 2001; 20(2):212.
4 J Am Coll Cardiol 2004; 43(9):1553-1561.