Paragonix Technologies Inc., Announces Filing of two 510(k) Pre-Market Notifications with the Food and Drug Administration

The two 510(k) FDA Pre-Market Notifications are intended 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

BRAINTREE, Mass.--()--Paragonix Technologies, Inc. today announced it has successfully completed the filing of two 510(k) Pre-Market Notifications with the Food and Drug Administration (FDA) to provide the Sherpa Pak™ Transport Systems with various organ preservation solutions currently marketed under 510(k) Pre-Market Clearance. The Sherpa Pak™ Transport systems are indicated for the static hypothermic preservation of organs during transportation and eventual transplantation into a recipient 1,2,3,4.

The first 510(k) Pre-Market Notification was filed to combine the Sherpa Pak™ Cardiac Transport System with any heart preservation solution currently marketed under 510(k) pre-market clearance.

The second 510(k) Pre-Market Notification was filed to combine the Sherpa Pak™ Kidney Transport System with any kidney preservation solution currently marketed under 510(k) pre-market clearance.

William Edelman, Chairman & CEO, for Paragonix commented, “We are excited to expand our product portfolio by providing a more comprehensive and convenient product offering that combines the Paragonix Sherpa Pak™ Systems and organ preservation solutions."

Previous Announcements

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 Sherpais 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 Patents issued and pending.

2 On February 6, 2013, Paragonix received FDA clearance of a 510(k) Pre-Market Notification for the Paragonix Sherpa Pak™ Cardiac Transport System

3 On February 24, 2014, Paragonix received FDA clearance of a second 510(k) Pre-Market Notification for the Paragonix Sherpa™ Cardiac Transport System

4 On May 28, 2014, Paragonix received FDA clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Pak Kidney Transport System

Contacts

Paragonix Technologies Inc.
Bill Edelman, 781-436-0509
Chairman of the Board
bill@paragonixtechnologies.com
www.paragonixtechnologies.com

Release Summary

Paragonix Technologies Inc., Announces Filing of two 510(k) Pre-Market Notifications with the Food and Drug Administration

Contacts

Paragonix Technologies Inc.
Bill Edelman, 781-436-0509
Chairman of the Board
bill@paragonixtechnologies.com
www.paragonixtechnologies.com