BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc., today announced that it has integrated tracking and sensing technology into its product portfolio, enabling real-time national tracking of all solid donor organs. Paragonix intends to combine the technology with Paragonix SherpaPak™ Transport Systems. The company plans to offer the combined capability under the SherpaTrak™ brand following regulatory pre-market clearance.
William Edelman, Chairman & CEO for Paragonix commented, “Tracking technology represents a tremendous opportunity to provide transplant teams real-time, national visibility to donor organ transportation. The need for greater access to tracking and transportation information of donor organs has been recognized by the transplant community in recent years, as demonstrated by efforts to automate the labeling of donor organs to ease paperwork load and ensure correct matching between donor and recipient1. The technology will provide real-time information on location, temperature, pressure, and tampering, and is supported by a robust, easy-to-use online platform maintained by a global logistics provider. Combining powerful tracking and sensing technology with the Sherpa family of organ transport devices will provide the clinical community a new set of tools to manage the movement of this precious resource on a national level.”
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
Paragonix previously announced on July 14, 2014, filing of a 510(k) Pre-market Notification with the US Food and Drug Administration for the Paragonix Sherpa Perfusion™ Cardiac Transport System
Paragonix previously announced on May 28, 2014, clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Pak Kidney Transport System
Paragonix previously announced on February 24, 2014, clearance of a second 510(k) Premarket Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System
Paragonix previously announced on January 27, 2014, a presentation discussing the Sherpa Perfusion™ Cardiac Transport System during the 2014 Cutting Edge of Transplantation Meeting
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.