Paragonix Technologies, Inc. today announced plans to present the SherpaPak™ Organ Transport Systems during the ASTS 17th Annual State of the Art Winter Symposium to be held in Miami, FL, between 26 to 29 January 2017. The SherpaPak™ Cardiac Transport System1,2 and SherpaPak™ Kidney Transport System3,4 combine innovative cooling technology with a safe, consistent method for cold ischemic storage and transport of donor hearts and kidneys to recipients for implantation. The ASTS Winter Symposium is organized by the American Society of Transplant Surgeons and is focused on innovative science to combat the shortage of life-saving donor organs.
Dr. Lisa Anderson, President and Chief Operating Officer, for Paragonix commented, “We are looking forward to discussing the SherpaPak™ Organ Transport Systems with the clinical community during the upcoming 2017 ASTS Winter Symposium. Since launching the SherpaPak™ product portfolio in 2016, the Paragonix team has been meeting with many transplant centers across the United States and we are excited that SherpaPak™ has generated such great clinical demand. We look forward to the opportunity to support many more transplant centers and organ procurement organizations across the nation with SherpaPak™ and organ preservation solutions for both donor kidneys and hearts.”
Previous Announcements
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
Paragonix previously announced June 29, 2016 a Product Supply Agreement with Waters Medical Systems LLC, for Waters IGL and Celsior® Cold Storage Solutions for Use With the SherpaPak™ Kidney Transport System and SherpaPak™ Cardiac Transport System
Paragonix and Essential Pharmaceuticals LLC previously announced June 28, 2016, a Product Supply Agreement for Custodiol® HTK Organ Preservation Solution for Use With the SherpaPak™ Cardiac Transport System and SherpaPak™ Kidney Transport System
Paragonix previously announced on July 23, 2015, Publication of “Innovative Cold Storage Of Donor Organs Using The Paragonix SherpaPak™ Devices"5
Paragonix previously announced on February 9, 2015, Innovative Tracking Technology For Real-Time, National Location Tracking of Donor Organs
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 hours7,8, 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 June 1, 2012, 3,203
patients in the United States are on the waiting list for a heart
transplant15. Based on 2011 data, just over 2,300 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™ Organ 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™ Cardiac Transport System is protected by patents, both issued and pending
2 The SherpaPak™ Cardiac Transport System has received FDA 510(k) pre-market clearance
3 The SherpaPak™ Cardiac Transport System is protected by patents, both issued and pending
4 The SherpaPak™ Cardiac Transport System has received FDA 510(k) pre-market clearance
5 Michel et al. Heart, Lung and Vessels; 2015;7(3):246-55
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
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