Paragonix Technologies Inc., Announces Clearance of Two 510(k) Premarket Notifications by the US Food and Drug Administration

The clearances allow the Paragonix Sherpa Pak Transport Systems to be combined and distributed with any FDA-cleared, commercially-available preservation solution.

BRAINTREE, Mass.--()--Paragonix Technologies, Inc. today announced it has received clearance of two 510(k) Premarket Notifications from the Food and Drug Administration (FDA) allowing combination of the Sherpa Pak™ Transport Systems with various currently marketed organ preservation solutions. 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 Sherpa Pak family of transport systems includes the Sherpa Pak Cardiac Transport System (CTS) and the Sherpa Pak Kidney Transport System (KTS). The CTS can now be combined in shipment kits with any preservation solution indicated for donor hearts that is cleared by the FDA. Similarly, the KTS can now be combined in shipment kits any preservation solution indicated for donor kidneys that is cleared by the FDA.

William Edelman, Chairman & CEO for Paragonix commented, “Achieving these two 510(k) Premarket clearances sets the stage for combining the Sherpa Pak Transport System with organ preservation solutions in a convenient format, simplifying hospital purchasing and organ transplant team logistics. These Premarket clearances are another step of several planned regulatory filings for enhancing our leadership in market management capabilities for the Sherpa Pak technology in organ preservation and transport.”

Previous Announcements

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 Premarket Notifications to combine the Paragonix Sherpa Pak Cardiac and Kidney Transport Systems with any effective organ preservation solution currently marketed under 510(k) Premarket 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 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

These FDA clearances allow the Paragonix Sherpa Pak Transport Systems to be combined and distributed with any FDA-cleared, commercially-available preservation solution.

Contacts

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