Paragonix Technologies Inc. Announces Presentation Of The Sherpapak And Sherpaperfusion Cardiac Transport Systems At The 37th Annual Meeting Of The International Society For Heart And Lung Transplantation (San Diego, 5 – 8 April 2017)

BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. will present the SherpaPak™ Organ Transport product line at Booth 321 during the 37^th Annual Meeting of the International Society for Heart and Lung Transplantation (ISHLT) held in San Diego, April 5-8, 2017. The SherpaPak™ Organ Transport product line^1,2 combines innovative cooling technology with safe, consistent methods for cold ischemic storage and transport of donor organs to recipients for implantation.

“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.”

During the ISHLT conference, Sebastian G.A. Michel, MD³ will present preclinical results for the SherpaPerfusion™ Cardiac Transport System^4,5 “12 hour hypothermic oxygenated machine perfusion preserves the quality of donor hearts: a biomarker analysis” on April 5 at 2:30PM PT. The SherpaPerfusion™ Cardiac Transport System is designed to improve donor heart quality during currently accepted clinical preservation intervals and to extend preservation times. Dr. Michel, lead author commented, “We are excited to present biomarker data gathered on porcine hearts preserved using SherpaPerfusion™ Cardiac Transport System for 12 hour transportation intervals.”

Dr. Lisa Anderson, President and COO, for Paragonix commented, “We are looking forward to discussing the SherpaPak™ Organ Transport Systems with the clinical community during the ISHLT Annual Meeting. ”

Previous Announcements
Paragonix previously announced February 7, 2017 a Distribution Agreement with MBA Medical to market Paragonix Technologies’ SherpaPak™ Cardiac and Kidney Transport Systems, in the Southern United States

Paragonix previously announced January 9, 2017 a Presentation of the SherpaPak™ Organ Transport Systems during the ASTS 17^th Annual State of the Art Winter Symposium January 26 to 29, 2017 in Miami, FL

Paragonix previously announced January 4, 2017 an Exclusive Supply Agreement with Sanbor Medical for the Manufacture and Assembly of SherpaPak™ Organ Transport Systems

Paragonix previously announced December 22, 2016 an Exclusive Distribution Agreement with Bio Instruments for Paragonix SherpaPak™ Cardiac and Kidney Transport Systems in the Midwestern United States

Paragonix previously announced November 9, 2016 an Exclusive Distribution Agreement with Pacific West Medical Sales for Paragonix SherpaPak™ Cardiac and Kidney Transport Systems in California

About the American Society of Transplant Surgeons
The American Society of Transplant Surgeons represents approximately 1,800 professionals dedicated to excellence in transplantation surgery. Their mission is to advance the art and science of transplant surgery through leadership, advocacy, education, and training.

About the Paragonix SherpaPak™ and SherpaPerfusion™ 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”) guidelines⁶ for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours^7,8, limiting the distance available to transport a donor heart. Paragonix SherpaPak^™ Cardiac Transport System is fully disposable, eliminating problems associated with maintenance, device transport and contamination. The Paragonix SherpaPerfusion^™ Cardiac Transport System combines innovative oxygenated perfusion of organs and safe organ storage with the ultimate goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts.

About the Cardiac Transplantation Market
Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure.⁹ With over 5.8 million Americans currently diagnosed with heart failure (HF), growing at an annual rate of 400,000 per year¹⁰, 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.¹¹ The annual economic burden of treating heart failure exceeds $34.4 billion¹², over 50% of which is due to the cost of hospitalization.¹³ 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 $30,000¹⁴. In the United States, around 30,000 people die annually from end-stage heart disease. As of March 24, 2017, 3,999 patients in the United States are on the waiting list for a heart transplant¹⁵. Based on 2016 data, just over 3,190 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 transplantation¹⁶, maximization of donor organ utilization has enormous potential in cardiac transplantation.

About Paragonix Technologies, Inc.
Based in Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix SherpaPak™ and SherpaPerfusion™ Cardiac Transport System, a novel, single-use organ preservation device to improve donor organ quality. Paragonix has established a pipeline of donor organ transport devices that address the current donor organ shortage by maximizing donor organ utilization, improving donor organ quality and extending donor organ transport throughout the entire United States.

¹ The SherpaPak™ Organ Transport product line is protected by patents, both issued and pending
² The SherpaPak™ Organ Transport product line has received FDA 510(k) pre-market clearance for both heart and kidney organ storage and transport
³ Dr. Michel is on the faculty of the Ludwig-Maximilians-University of Munich
⁴ The SherpaPerfusion™ Cardiac Transport System is not approved for sale at this time
⁵ The SherpaPerfusion™ Cardiac Transport System is protected by patents, both issued and pending
⁶ ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)
⁷ J Heart Lung Transplant 2001; 20(2):212.
⁸ J Am Coll Cardiol 2004; 43(9):1553-1561.
⁹ 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
¹⁰ Circulation 2010;121:e46-e215
¹¹ http://about.datamonitor.com/media/archives/314
¹² Circulation 2011;123(8):933-944
¹³ Circulation 2007;115(5)
¹⁴ http://www.transplantliving.org
¹⁵ http://optn.transplant.hrsa.gov
¹⁶ http://www.uptodate.com/contents/heart-transplantation-beyond-the-basics