Paragonix Technologies Inc., Announces Filing of a 510(k) Pre-market Notification with the US Food and Drug Administration for the Paragonix Sherpa Perfusion™ Cardiac Transport System
The Sherpa Perfusion™ Cardiac Transport System can be used for either hypothermic oxygenated perfusion or static storage of donor hearts during transport
BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced that it has successfully completed filing of a 510(k) Pre-market notification with the US Food and Drug Administration (FDA) for its Sherpa Perfusion™ Cardiac Transport System (CTS)1,2. 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.
“Cardiac transplantation continues to be the gold standard for the treatment of end-stage heart failure. However, the number of potential transplants far exceeds the number of donors.”
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."
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.
About Excel Venture Management
Excel Venture Management builds companies that apply transformative technologies to solve problems in healthcare and beyond. The Excel investment portfolio is balanced across healthcare IT and services, diagnostics, and medical devices, plus life science platforms that address adjacent markets including energy, chemicals, defense and agriculture. The firm’s investments include Tetraphase (TTPH), Aileron, Cleveland Heart Lab, Synthetic Genomics, and IlluminOss. More information can be found at http://www.excelvm.com.
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 the Cardiac Transplantation Market
Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure.7 With over 5.8 million Americans currently diagnosed with heart failure (HF), growing at an annual rate of 400,000 per year8, there is a persistent need to provide end-stage heart failure support to this expanding population. Estimates of the prevalence of symptomatic HF in the general European population are similar to those in the United States.9 The annual economic burden of treating heart failure exceeds $34.4 billion10, over 50% of which is due to the cost of hospitalization.11 The financial demands associated with transplantation are considerable. The estimated first year costs for heart transplant are $997,700, and subsequent annual costs can easily exceed $30,00012. In the United States, around 30,000 people die annually from end-stage heart disease. As of June 1, 2012, 3,203 patients in the United States are on the waiting list for a heart transplant13. Based on 2011 data, just over 2,300 patients will receive a live-saving transplant each year, which is reflective of the enormous donor heart shortage. These data, however, only seem to represent the tip of the iceberg. Assuming that up to 50,000 people with end-stage heart failure are candidates for transplantation14, maximization of donor organ utilization has enormous potential in cardiac transplantation.
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 Not approved for sale.
3 On February 6, 2013, Paragonix received FDA clearance of a 510(k) Pre-Market Notification for the Paragonix Sherpa Pak™ Cardiac Transport System
4 On February 24, 2014, Paragonix received FDA clearance of a second 510(k) Pre-Market Notification for the Paragonix Sherpa™ Cardiac Transport System
5 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
6 Excel Venture Management is not an equity investor in Paragonix Technologies, Inc.
7 Datamonitor senior cardiovascular analyst Dr. Sergey Ishin. “Cardiac transplantation continues to be the gold standard for the treatment of end-stage heart failure. However, the number of potential transplants far exceeds the number of donors.” http://about.datamonitor.com/media/archives/314
8 Circulation 2010;121:e46-e215
10 Circulation 2011;123(8):933-944
11 Circulation 2007;115(5)