Paragonix Technologies has signed a supply agreement with Sanbor Medical for the manufacture and assembly of SherpaPak cardiac transport system and SherpaPak kidney transport system.
Sanbor Medical is a vertically integrated medical device contract manufacturer based in Allentown, PA.
Bill Edelman, Chairman and CEO, for Paragonix commented, “We are excited to partner with Sanbor Medical, a contract manufacturer for medical devices. Sanbor Medical has the expertise, scale and infrastructure for the production of the SherpaPak™ Organ Transport Systems.
“This supply agreement will accelerate our commercialization strategy for the Paragonix SherpaPak™ product portfolio. This agreement will enable Paragonix to meet growing clinical demand for SherpaPak™.”
Paragonix previously announced December 22, 2016 an exclusive distribution agreement with Bio Instruments for Paragonix SherpaPak™ Cardiac and Kidney Transport Systems in the Midwestern United States
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 on July 23, 2015, Publication of “Innovative Cold Storage Of Donor Organs Using The Paragonix SherpaPak™ Devices”5
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
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”) guidelines6 for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours7,8, 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.