[March 27, 2017] |
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Paragonix Technologies Inc., Announces Presentation of the SherpaPak™ and SherpaPerfusion™ Cardiac Transport Systems at the 37th Annual Meeting of the International Society for Heart and Lung Transplantation (San Diego, 5 - 8 April 2017)
Paragonix Technologies, Inc. will present the SherpaPak™ Organ Transport
product line at Booth 321 during the 37th Annual Meeting of
the International Society for Heart and Lung Transplantation (ISHLT)
held in San Diego, April 5-8, 2017. The SherpaPak™ Organ Transport
product line1,2 combines innovative cooling technology with
safe, consistent methods for cold ischemic storage and transport of
donor organs to recipients for implantation.
During the ISHLT conference, Sebastian G.A. Michel, MD3 will
present preclinical results for the SherpaPerfusion™ Cardiac Transport
System4,5 "12 hour hypothermic oxygenated machine
perfusion preserves the quality of donor hearts: a biomarker analysis"
on April 5 at 2:30PM PT. The SherpaPerfusion™ Cardiac Transport System
is designed to improve donor heart quality during currently accepted
clinical preservation intervals and to extend preservation times. Dr.
Michel, lead author commented, "We are excited to present biomarker data
gathered on porcine hearts preserved using SherpaPerfusion™ Cardiac
Transport System for 12 hour transportation intervals."
Dr. Lisa Anderson, President and COO, for Paragonix commented, "We are
looking forward to discussing the SherpaPak™ Organ Transport Systems
with the clinical community during the ISHLT Annual Meeting. "
Previous Announcements Paragonix previously announced
February 7, 2017 a Distribution Agreement with MBA Medical to market
Paragonix Technologies' SherpaPak™ Cardiac and Kidney Transport Systems,
in the Southern United States
Paragonix previously announced January 9, 2017 a Presentation of the
SherpaPak™ Organ Transport Systems during the ASTS 17th
Annual State of the Art Winter Symposium January 26 to 29, 2017 in
Miami, FL
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
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 March 24, 2017, 3,999
patients in the United States are on the waiting list for a heart
transplant15. Based on 2016 data, just over 3,190 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™ 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 clearance for
both heart and kidney organ storage and transport 3 Dr.
Michel is on the faculty of the Ludwig-Maximilians-University of Munich 4
The SherpaPerfusion™ Cardiac Transport System is not approved for sale
at this time 5 The SherpaPerfusion™ Cardiac Transport
System is protected by patents, both issued and pending 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170327005068/en/
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