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Paragonix Technologies to Present Abstract on the Sherpa Perfusion Cardiac Transport System for 2014 CEOT

January 30, 2014

Paragonix Technologies announced acceptance of an abstract describing the performance of the Sherpa Perfusion Cardiac Transport System to be presented at the upcoming 2014 Cutting Edge of Transplantation (CEOT)1 Meeting in Chandler, Arizona , from the 13th to the 15th of February 2014 . According to a release, the 2014 CEOT Meeting is organized by the American Society of Transplantation2 and is focused on long-term transplant survival. In addition, Paragonix noted: Lisa M. Anderson , PhD, co-author on the abstract and Chief Operating Officer and Co-Founder for Paragonix commented, "We are delighted to present the Sherpa Perfusion Cardiac Transport System during the CEOT Meeting. The presentation will include in vivo pre- clinical data generated as part of the just completed Phase I Small Business Innovation Research Grant awarded to Paragonix by the National Heart, Lung and Blood Institute3." Dr. Joren C. Madsen , MD, DPhil,4 senior author on the abstract and Director of the Massachusetts General Hospital Transplant Center, Boston , commented, "The CEOT is an exciting platform to showcase new technology that addresses the current problems we face in organ transplantation. The Sherpa Perfusion Cardiac Transport System represents an innovative approach to heart storage and transportation. I look forward to discuss this technology with my colleagues at the meeting." Previous AnnouncementsParagonix previously announced on December 18, 2013 , closing of the Company's convertible $1.1M debt financing. Paragonix previously announced on December 17, 2013 , filing of a 510(k) Pre-market Notification Application with the US Food and Drug Administration for the Paragonix Sherpa Pak Transporter. Paragonix previously announced on November 18, 2013 , filing of a second 510(k) Pre-Market 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 Cardiac Transport System. Paragonix previously announced on November 6, 2012 , filing of a 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 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 . Currently, the availability of cardiac transplantation is governed by the "ischemic time", that being, the elapsed time from heart donation to recipient implantation. According to The International Society Of Heart and Lung Transplantation ("ISHLT") guidelines5 for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours6,7, limiting the distance available to transport a donor heart. The Paragonix Sherpa combines innovative oxygenated perfusion of organs and safe organ storage with the goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts. Paragonix Sherpa is fully disposable, eliminating problems associated with maintenance, device transport and contamination. Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure.8 With over 5.8 million Americans currently diagnosed with heart failure (HF), growing at an annual rate of 400,000 per year9, 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.10 The annual economic burden of treating heart failure exceeds $34.4 billion11, over 50 percent of which is due to the cost of hospitalization.12 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 $30,00013 . 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 transplant14. 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 transplantation15, maximization of donor organ utilization has enormous potential in cardiac transplantation. The Cutting Edge of Transplantation 2014 ( February 13-15 in Chandler, AZ ) is a meeting that will tackle the problem of long- term survival, one of the most difficult problems in organ transplantation. The meeting will focus on better understanding the problem and what can be done about it through the emergence of new technology, targets and therapeutics. The American Society of Transplantation is an international organization dedicated to advancing the field of transplantation. Paragonix Technologies is a privately held medical device company. ((Comments on this story may be sent to newsdesk@closeupmedia.com ))


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