Market Overview

Paragonix Technologies Inc., Announces ISO 13485:2016 Certification


Paragonix Technologies, Inc., a commercial-stage medical device company
marketing the Paragonix SherpaPak™ Cardiac Transport System1,2,
announced today that the Company has received ISO 13485:2016
certification for its Quality Management System (QMS) following review
by the British Standards Institute (BSI). ISO 13485:2016 is an
internationally recognized quality standard specific to the medical
device industry. ISO 13485:2016 demonstrates Paragonix's commitment to
the highest level of medical device quality controls and to meeting
customer and international regulatory expectations. Certification
required Paragonix to undergo the BSI Audit before March 2019, to ensure
uninterrupted product availability to a growing customer base

Adam Collette, Ph.D., VP Commercial Operations, for Paragonix commented,
"We are very proud to have certified our QMS as compliant with ISO
13485:2016. Our team's focus on creating a "quality-first" culture led
to achievement of this milestone well ahead of schedule. "

The Paragonix SherpaPak™ Organ Transport System product portfolio1,2
combines innovative cooling technology with safe, consistent methods for
cold ischemic storage and transport of donor organ to recipients for
implantation. The Paragonix SherpaPak™ System consists of multiple
components; 1) an outer transport shipper which temperature controlled
elements, 2) a sterile, nesting organ canister set which provides a
double, rigid barrier in which the organ is immersed and suspended in a
cold storage fluid cleared for use in storing and transporting donor
organs, 3) a data logger that monitors the temperature of the organ
during transport, and 4) a Bluetooth-connectivity to monitor, record and
download preservation temperature and storage times to handheld devices.

Bill Edelman, Chairman & CEO, for Paragonix commented, "Our dedicated
team of safety and quality experts is a key pillar of Paragonix's
commitment to world-class, high-quality products. With the
implementation of ISO13485:2016, Paragonix is fully aligned with global
regulatory requirements. We are looking forward to supporting the
transplant community with the Paragonix SherpaPak™ Cardiac Transport
System in the US and in Europe."

Previous Announcements

Paragonix previously announced July 18, 2018 Partnership with the Lung
Transplant Foundation to Support Commercialization of Paragonix™
SherpaLung for improved donor lung transport

Paragonix previously announced April 3, 2018 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 (Nice, France, April 11 – 14, 2018).

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

Paragonix previously announced February 20, 2018 European Conformity
("CE")3 Premarket Clearance for the SherpaPak™ Cardiac
Transport System and SherpaPerfusion™ Cardiac Transport System Family of
Organ Transport Products.

About ISO13485:2016

ISO 13485:2016 has been harmonized to the European Medical Devices
Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 now replaces the
previous version of the standard, EN ISO 13485:2012. Standard
harmonization allows manufacturers to use their compliance to the
standard as evidence of conformity to the requirements of relevant

About the Paragonix SherpaPak™ and SherpaPerfusion™ Cardiac Transport

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") guidelines5 for the care
of heart transplant recipients, the projected ischemic time should not
exceed 4 hours6,7, 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 failure8. With over 6.5 million
Americans currently diagnosed with heart failure (HF)9, 10%
of which are diagnosed with end-stage heart failure10, 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 States11.
In 2017, over 2,000 donor hearts were transplanted in Europe12.

The annual US economic burden of treating heart failure exceeds $34.4
billion13, over 50% of which is due to the cost of
hospitalization14. 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 $30,00015. 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
transplant16 and close to 4,000 patients in Europe are on the
waiting list for a heart transplant every year17. In 2017,
3,244 patients in the United States18 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 transplantation19, 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™, SherpaPerfusion™ and SherpaLung™ Organ Transport Systems,
which are novel, single-use organ preservation devices 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.


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) premarket clearances and
CE mark approval for both heart and kidney organ storage and transport
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.
ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force
1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)
J Heart Lung Transplant 2001; 20(2):212.
7 J Am Coll
Cardiol 2004; 43(9):1553-1561.
8 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."
Circulation 2011;123(8):933-944
14 Circulation
J Heart Lung Transplant 2011;30:1078-94

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