Paragonix Technologies Inc., Announces Presentation of the Paragonix SherpaPak™ Cardiac Transport System at the 98th Annual Meeting of the American Association of Thoracic Surgeons in San Diego, April 28- May 1, 2018

BRAINTREE, Mass.--()--Paragonix Technologies, Inc. will present the Paragonix SherpaPak™ Cardiac Transport System product line at Booth 340 during the 98th Annual Meeting of the American Association of Thoracic Surgeons (AATS) held in San Diego, from April 28 to May 1, 2018. The Paragonix SherpaPak™ Cardiac Transport System product line1,2 combines innovative cooling technology with safe, consistent methods for cold ischemic storage and transport of donor hearts to recipients for implantation.

Bill Edelman, Chairman & CEO, for Paragonix commented, “We are looking forward to discussing the Paragonix SherpaPak™ Cardiac Transport System with the clinical community during the AATS Annual Meeting. We are excited to see the support of the transplant community as the Paragonix SherpaPak™ Cardiac Transport System enters commercial distribution in the US and Europe. ”

Previous Announcements

Paragonix previously announced April 3, 2018 Presentation of the SherpaPak™ Cardia Transport Systems and SherpaPerfusion™ Cardiac Transport System at the 38th Annual Meeting of the International Society for Heart and Lung Transplantation (Nice, France, April 11 – 14, 2018).

Paragonix previously announced March 26, 2018 Appointment of Carl Rickenbaugh to the Board of Directors.

Paragonix previously announced February 20, 2018 European Conformity (“CE”)3 Premarket Clearance for the SherpaPak™ Cardiac Transport System and SherpaPerfusion™ Cardiac Transport System Family of Organ Transport Products.

Paragonix previously announced August 8, 2017 Extension of Product Portfolio with the Addition of SherpaPak™ Lung Transport System.

Paragonix previously announced April 24, 2017 Presentation of the SherpaPak™ Organ Transport Systems at the American Transplant Congress (ATC) (Chicago, April 29 – May 3, 2017).

Paragonix previously announced March 27, 2017 Presentation of the SherpaPak™ Organ Transport Systems and SherpaPerfusion™ Cardiac Transport System at the 37th Annual Meeting of the International Society for Heart and Lung Transplantation (San Diego, 5 – 8 April 2017).

About the AATS

The American Association for Thoracic Surgery is an international organization of over 1,300 of the world's foremost cardiothoracic surgeons representing 41 countries. Founded in 1917, its members have a proven record of distinction within the specialty and have made significant contributions to the care and treatment of cardiothoracic disease throughout the world.

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”) guidelines4 for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours5,6, 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 failure7. With over 6.5 million Americans currently diagnosed with heart failure (HF)8, 10% of which are diagnosed with end-stage heart failure9, 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 States10. In 2017, over 2,000 donor hearts were transplanted in Europe11.

The annual US economic burden of treating heart failure exceeds $34.4 billion12, over 50% of which is due to the cost of hospitalization13. 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 February 2018, 3,990 patients in the United States are on the waiting list for a heart transplant15 and close to 4,000 patients in Europe are on the waiting list for a heart transplant every year16. In 2017, 3,244 patients in the United States17 and over 2,000 European patients received a live-saving heart transplant19. These data, however, only seem to represent the tip of the iceberg. Assuming that up to 157,000 people with end-stage heart failure are candidates for transplantation18, 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 clearances and CE mark approval for both heart and kidney organ storage and transport
3 The CE mark (Conformité Européenne, meaning "European Conformity,” formerly EC mark) according to the European Medical Directive (MDD) is a mandatory conformity mark for medical devices placed on the market in the European Economic Area (EEA). With the CE marking on a medical device, the manufacturer ensures that the product conforms to the essential requirements of the applicable EC medical device directives.
4 ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)
5 J Heart Lung Transplant 2001; 20(2):212.
6 J Am Coll Cardiol 2004; 43(9):1553-1561.
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 http://newsroom.heart.org/news/latest-statistics-show-heart-failure-on-the-rise;-cardiovascular-diseases-remain-leading-killer
9 http://www.heart.org/HEARTORG/Conditions/HeartFailure/LivingWithHeartFailureAndAdvancedHF/Advanced-Heart-Failure_UCM_441925_Article.jsp#.WosY7GNLPjI
10 http://about.datamonitor.com/media/archives/314
11 http://www.transplant-observatory.org
12 Circulation 2011;123(8):933-944
13 Circulation 2007;115(5)
14 http://www.transplantliving.org
15 http://optn.transplant.hrsa.gov
16 https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/ev_20141126_factsfigures_en.pdf
17 https://unos.org/data/transplant-trends/#transplants_by_organ_type+year+2017
18 J Heart Lung Transplant 2011;30:1078-94

Contacts

For Further Information:
Paragonix Technologies Inc.
Bill Edelman, 781-436-0509 o/c
bill@paragonixtechnologies.com
www.paragonixtechnologies.com

Release Summary

Paragonix Technologies Inc., Announces Presentation of the Paragonix SherpaPak™ Cardiac Transport System at the 98th Annual Meeting of the AATS

Contacts

For Further Information:
Paragonix Technologies Inc.
Bill Edelman, 781-436-0509 o/c
bill@paragonixtechnologies.com
www.paragonixtechnologies.com