Paragonix Technologies, Inc. Announces Presentation of the SherpaPak™ Cardiac Transport Systems and SherpaPerfusion™ Cardiac Transport System at the 38th Annual Meeting of the International Society for Heart and Lung Transplantation

During the ISHLT conference, Paragonix will announce the European launch of the SherpaPak™ Cardiac Transport System and SherpaPerfusion™ Cardiac Transport system.

Juan-Miguel Gil-Jaurena, MD, Cardiac Surgeon at Gregorio Marañon University Hospital, Madrid, Spain and Board Member of the Spanish Society of Cardiology and European Congenital Heart Surgeons Association member, commented, “For years, we have faced many problems related to heart transplantation. Transportation was not considered a big issue because it is has been done same way since the heart transplant programs started 50 years ago. However, now that many of the biggest technical transplantation issues have been solved, we are now begin to believe that the transportation of the donor organ can be improved. Any step forward in organ procurement and preservation is worthwhile and welcome. It seems that Paragonix has addressed this critical issue with its advanced SherpaPak™ Cardiac Transport system and SherpaPerfusion™ Cardiac Transport systems. We hope to begin a collaboration with Paragonix soon.”

Sebastian G.A. Michel, MD, a Cardiothoracic Surgeon at the Ludwig-Maximilians-University of Munich, Germany, commented, “Following my earlier studies of SherpaPak™ and SherpaPerfusion™ during my research fellowship at Massachusetts General Hospital in Boston, USA, I have been looking forward to the introduction of both products in Europe. My team previously reported preclinical data regarding SherpaPerfusion^3,4 at the 37th Annual Meeting of the International Society for Heart and Lung Transplantation⁵. SherpaPerfusion™ Cardiac Transport System is designed to improve donor heart quality during currently accepted clinical preservation intervals and to extend preservation times. SherpaPak™ is a great advance over the current ice storage and SherpaPerfusion™ will open up the possibility of greater geographic procurement of donor organs.”

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

Previous Announcements

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

Paragonix previously announced February 20, 2018 European Conformity (“CE”)⁶ 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 ISHLT

The International Society for Heart and Lung Transplantation (ISHLT) is a not-for-profit, multidisciplinary, professional organization dedicated to improving the care of patients with advanced heart or lung disease through transplantation, mechanical support and innovative therapies via research, education and advocacy.

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”) guidelines⁷ for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours^8,9, 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 failure¹⁰. With over 6.5 million Americans currently diagnosed with heart failure (HF)¹¹, 10% of which are diagnosed with end-stage heart failure¹², 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 States¹³. In 2017, over 2,000 donor hearts were transplanted in Europe¹⁴.

The annual US economic burden of treating heart failure exceeds $34.4 billion¹⁵, over 50% of which is due to the cost of hospitalization¹⁶. 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 $30,000¹⁷. 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 transplant¹⁸ and close to 4,000 patients in Europe are on the waiting list for a heart transplant every year¹⁹. In 2017, 3,244 patients in the United States²⁰ 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 transplantation²¹, 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 SherpaPerfusion™ Cardiac Transport System has received CE mark approval but is not approved for sale in the US
⁴ The SherpaPerfusion™ Cardiac Transport System is protected by patents, both issued and pending
⁵ “12 Hour Hypothermic Oxygenated Machine Perfusion Preserves The Quality of Donor Hearts: A Biomarker Analysis” Michel et al. 37^th ISHLT Annual Meeting
⁶ 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.
⁷ ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)
⁸ J Heart Lung Transplant 2001; 20(2):212.
⁹ J Am Coll Cardiol 2004; 43(9):1553-1561.
¹⁰ 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
¹¹ http://newsroom.heart.org/news/latest-statistics-show-heart-failure-on-the-rise;-cardiovascular-diseases-remain-leading-killer
¹² http://www.heart.org/HEARTORG/Conditions/HeartFailure/LivingWithHeartFailureAndAdvancedHF/Advanced-Heart-Failure_UCM_441925_Article.jsp#.WosY7GNLPjI
¹³ http://about.datamonitor.com/media/archives/314
¹⁴ http://www.transplant-observatory.org
¹⁵ Circulation 2011;123(8):933-944
¹⁶ Circulation 2007;115(5)
¹⁷ http://www.transplantliving.org
¹⁸ http://optn.transplant.hrsa.gov
¹⁹ https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/ev_20141126_factsfigures_en.pdf
²⁰ https://unos.org/data/transplant-trends/#transplants_by_organ_type+year+2017
²¹ J Heart Lung Transplant 2011;30:1078-94