CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced that its flagship product, Paragonix SherpaPak™ Cardiac Transport System (CTS), is the recipient of a prestigious international design award: the Red Dot Award.
The traditional mechanism by which organs are transported (bagged on ice in a consumer cooler) has remained unchanged for more than 50 years—until now.
“Every organ donation is the ultimate gift – and this decision is frequently made in the most difficult of circumstances,” said Lisa Anderson, Ph.D., Co- Founder, President and COO of Paragonix Technologies. “We knew we could create a reliable, predictable system to ensure that every time someone makes this sacrifice this incredible gift is made, we provide that organ the highest best possible advantage quality conditions to reach the transplant recipient.”
The founder of Paragonix was inspired to create a more precise, controlled, and consistent new method based on her prior experience as a medical researcher. As part of a pre-clinical study, she recognized the disadvantages of the traditional ice cooler method and felt compelled to research and design an alternative.
Like other groundbreaking innovations, the founding team knew they had to design and build this first-of-its-kind preservation system from the ground up. The design team set out to design a product that would be easy-to-use in stressful, high-stakes environments where there is no room for mistakes.
Following four FDA and European market clearance, Paragonix SherpaPak CTS has been in clinical use since 2018 and has seen rapid adoption around the world. In the past two years, multiple centers have reported positive results from the use of the device both in procedural experience and in pediatric and adult patient clinical outcomes.
The 2020 Red Dot Award program received its highest number of entries ever—a staggering 6,500 products from over 60 countries—an increase of more than 18% compared to the year prior. Those who win the coveted design award are considered products that feature outstanding design. Submissions were assessed for overall product design, durability, quality, and functionality.
In selecting Paragonix SherpaPak CTS, the jurors recognized its innovative, human-centered product design among thousands of other entries in the medical field, “This cardiac transport system impresses with its clever functionality, which ensures that donor hearts arrive safely at the place of transplantation.”
Paragonix continues its mission to safeguard donor hearts, and in turn, to save more lives, with its award-winning, life-saving medical devices.
About Red Dot Award
The distinction “Red Dot” has become established internationally as one of the most sought-after seals of quality for good design. The Red Dot Award: Product Design, whose origins date back to 1955, appraises the best products created every year. In 49 categories, manufacturers and designers can enter their innovations in the competition.
According to the motto “In search of good design and innovation,” the international Red Dot Award jury only awards this seal to products that feature an outstanding design.
About Paragonix Technologies
Paragonix Technologies designs, produces, and markets organ preservation and transport devices that safeguard organs during the journey between donor and recipient patients. Our award-winning devices mitigate risk in an otherwise high stakes environment. The Paragonix SherpaPak systems 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 preservation. Paragonix is also developing transport devices for the lung, pancreas, kidney and liver designed to improve donor organ quality and extend donor organ preservation time.
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 2017, over 2,000 donor hearts were transplanted in Europe5.
The annual U.S. economic burden of treating heart failure exceeds $42.9 billion6, over 50% of which is the cost of hospitalization7. The financial demands associated with transplantation are considerable. The estimated first-year costs for a heart transplant are $997,700, and subsequent annual costs usually exceed $30,0008. In the United States, around 30,000 people die annually from end-stage heart disease. As of February 2018, 3,990 U.S. patients were on the waiting list for a heart transplant9 and a similar number of European patients – close to 4,000 – are on the waiting list for a heart transplant every year10. Unfortunately, only a small minority of patients on these waiting lists receive the live-saving transplants they need. In 2019, 3,551 patients in the United States11 and over 2,000 European patients received a life-saving heart transplant.
Many patients for whom a heart transplant would be clinically indicated do not even appear on waiting lists. These data, therefore, only represent the tip of the iceberg of the market for organ transplant procedure volume. Studies indicate that up to 157,000 U.S. patients with end-stage heart failure are candidates for transplantation12, implying that maximization of donor organ utilization has enormous potential in cardiac transplantation.
1Datamonitor 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.” https://european-hospital.com/media/issue/161/issue.pdf
2http://newsroom.heart.org/news/latest-statistics-show-heart-failure-on-the-rise;-cardiovascular-diseases-remain-leading-killer
3http://www.heart.org/HEARTORG/Conditions/HeartFailure/LivingWithHeartFailureAndAdvancedHF/Advanced-Heart-Failure_UCM_441925_Article.jsp#.WosY7GNLPjI
4https://european-hospital.com/media/issue/161/issue.pdf
5http://www.transplant-observatory.org
6Circulation 2011;123(8):933-944
7Circulation 2007;115(5):e69-e171
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
12J Heart Lung Transplant 2011;30(10):1078-94
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Contacts
Michael Tajima
(781) 428.4153
mtajima@paragonixtechnologies.com
www.paragonixtechnologies.com
