This represents the fourth pre-market application for the Company’s Sherpa family of organ preservation and transport technologies. The Sherpa Perfusion™ CTS is intended to be used for either hypothermic static preservation or oxygenated perfusion preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Sherpa Perfusion Cardiac Transport System is up to 4 hours.
This announcement follows the recent clearances of several Pre-Marketing Notifications (510(k)) with the U.S. Food and Drug Administration (FDA) for the Paragonix Sherpa Pak™ Transporter Systems1,3,4,5. The Sherpa Pak™ Transport Systems are indicated for the static hypothermic preservation of organs during transportation and eventual transplantation into a recipient.
William Edelman, Chairman & CEO, for Paragonix commented, "Following our recent SherpaTM pre-market clearances granted by FDA for both heart and kidney storage and transport, and the positive responses we have received from the clinical community for the Sherpa portfolio of organ transport products, we are pleased to have filed a 510(k) Pre-market Notification with the FDA for the Sherpa Perfusion™ CTS."
Dr. Len Golding, MB, BS, FRACS, FACC, Chief Medical Officer for Paragonix Technologies, Inc., and Retired Consultant Staff in the Department of Biomedical Engineering at the Cleveland Clinic, commented, "I believe that the clinical advantages of the Sherpa Perfusion™ CTS include its ease-of-use, systematization of organ recovery and preservation process, and the lack of expensive capital equipment necessary to perform its function. I have devoted an important part of my career to finding solutions for organ preservation and transport as they are in short supply world-wide."
Caleb Winder, Managing Director for Excel Venture Management6 (Boston) commented, "I am pleased to see Paragonix actively moving to its next stage of development. I have been tracking Paragonix throughout its successes in gaining FDA pre-market clearances for both cardiac and kidney transport products and firmly believe that the organ transplant sector has been seeking innovative technology such as the Paragonix Sherpa™ System for many years. There continues to be a significant shortage of organs for transplantation, especially heart, and I look forward to seeing Paragonix succeed with the Sherpa™ family of organ transport technologies."
Previous Announcements
Paragonix previously announced 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
Paragonix previously announced on December 18, 2013, closing of a $1.1M Convertible Debt Financing
Paragonix previously announced on December 17, 2013, filing of a third 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Pak Kidney Transport System
Paragonix previously announced on November 18, 2013, the filing of a second 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System
Paragonix previously announced on July 22, 2013, Publication by the ASAIO (American Society for Artificial Internal Organs) Journal of "Oxygen Consumption during Oxygenated Hypothermic Perfusion as a Measure of Donor Organ Viability"
Paragonix previously announced on June 10, 2013, Presentation of "An Innovative, Novel Hypothermic Storage System For Donor Hearts," discussing the Sherpa Pak™ Cardiac Transport System during the 16th Congress of the European Society for Organ Transplantation held in Vienna, Austria, 8th – 11th September 2013
Paragonix previously announced on February 12, 2013, clearance of a 510(k) pre-marketing notification application with the US Food and Drug Administration for the Paragonix Sherpa™ Pak Cardiac Transport System
Paragonix previously announced on July 16, 2012, award of a Phase I Small Business Innovation Research (SBIR) Grant to support the pre-clinical development of the Paragonix Sherpa™ Cardiac Transport in collaboration with the Transplant Center at Massachusetts General Hospital (Boston).
Paragonix previously announced on June 25, 2012, Appointment of Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC as Chief Medical Officer.
Paragonix previously announced on June 18, 2012, Formation of a Clinical Advisory Board for the Paragonix Sherpa™ Cardiac Transport System.
