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23-Jan-2019

Paragonix Technologies Announces Presentation of the Paragonix SherpaPak™ Cardiac Transport System at the 55th Society of Thoracic Surgeons Annual Meeting

Paragonix Technologies, Inc. will present the Paragonix SherpaPak™ Cardiac Transport System product line at Booth 924 during the 55th Annual Meeting of the Society of Thoracic Surgeons (STS) held in San Diego, from January 27 to January 29, 2019. The Paragonix SherpaPak™ CTS is the only FDA cleared and CE marked system for donor organ heart transport and storage. The Paragonix SherpaPak™ CTS has been used by heart transplant centers in both the United States and in Europe. The device is currently marketed in the United States, and in the United Kingdom, France, Spain, Italy, Germany, Austria, Sweden and Slovak Republic in Europe.

“For decades the off-the-shelf picnic cooler has been the standard for transporting and delivering organs such as the heart from donor to recipient patient, but there is no control over temperature which can result in uneven cooling and freezing of the heart. With the Paragonix SherpaPak™ CTS, the temperature remains constant during transport, safeguarding the organ against injury during transport and making it viable for transplant,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “We are excited to report on global clinical use experience with this innovative donor heart transport technology at STS and provide data on device performance as well as initial clinical feedback.”

Previous Announcements
On December 20, 2018, Paragonix Technologies, Inc., announced 510(k) clearance allowing for the use of the Paragonix SherpaPak™ CTS with pediatric and small donor hearts. With this indication, the Paragonix SherpaPak™ CTS is now available for all donor populations.

On September 30, 2018, Paragonix Technologies, Inc., announced Clinical Use of the Paragonix SherpaPak™ CTS in world-renowned transplant centers as well as first-in-man use at Massachusetts General Hospital, Boston.

About the Cardiac Transplantation Market
Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure1. With over 6.5 million Americans currently diagnosed with heart failure (HF)2, 10% of which are diagnosed with end-stage heart failure3, 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 States4. In 2018, over 6,500 donor hearts were transplanted in the US and Europe5.

The annual US economic burden of treating heart failure exceeds $34.4 billion6, over 50% of which is due to the cost of hospitalization7. 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 $30,0008. 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 were on the waiting list for a heart transplant9 and close to 4,000 patients in Europe are on the waiting list for a heart transplant every year10. In 2017, 3,244 patients in the United States11 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 transplantation12, maximization of donor organ utilization has enormous potential in cardiac transplantation.

About the Society of Thoracic Surgeons
Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing over 7,200 surgeons, researchers and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest.

About the Paragonix SherpaPak™ Cardiac Transport System
The Paragonix SherpaPak™ Cardiac Transport System (CTS) safeguards hearts during the journey from donor to recipient patient. Our device incorporates clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix SherpaPak™ CTS is the only commercially available FDA cleared and CE marked medical device for heart transportation.

About Paragonix Technologies, Inc.
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix SherpaPak™ CTS is the only commercially available FDA cleared and CE marked transport device for heart transportation. Paragonix is also developing transport devices for the lung and kidneys designed to improve donor organ quality and extending donor organ transport time.

1 Datamonitor senior cardiovascular analyst Dr. Sergey Ishin. “Cardiac transplantation continues to be the goldstandard for the treatment of end-stage heart failure. However, the number of potential transplants far exceedsthe number of donors.” http://about.datamonitor.com/media/archives/314
2http://newsroom.heart.org/news/latest-statistics-show-heart-failure-on-the-rise;-cardiovascular-diseases-remain-leading-killer
3 Company data on file
4http://about.datamonitor.com/media/archives/314
5http://www.transplant-observatory.org
6 Circulation 2011;123(8):933-944
7 Circulation 2007;115(5)
8http://www.transplantliving.org
9http://optn.transplant.hrsa.gov
10https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/ev_20141126_factsfigures_en.pdf
11https://unos.org/data/transplant-trends/#transplants_by_organ_type+year+2017
12 J Heart Lung Transplant 2011;30:1078-94

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Last Updated: 23-Jan-2019