Date: Feb 24, 2014 Author: press release Source: Company Data (
click here to go to the source)
BRAINTREE, Mass.--(
BUSINESS WIRE
)--Paragonix Technologies, Inc. today announced that it has received
clearance for its second Premarket Notification (510(k)) with the US Food and Drug Adm
inistration (FDA) for
its Paragonix Sherpa Pak™ Cardiac Transport System
(CTS).
"Oxygen Consumption during Oxygenated Hypothermic Perfusion as a
Measure of Donor Organ Viability"
The Sherpa Pak™ Cardiac Transport System is "intended to be used for the static hypot
hermic preservation
of hearts during transportation and eventual transplantation into a recipient using c
old storage solutions
indicated for use with the heart. The intended organ storage time for the Sherpa Pak
Cardiac Transport
System is up to 4 hours".
As described in the product's labeling, following assembly, the Sherpa Pak CTS™ is ca
pable of maintaining
cold storage solution temperature between 4° and 8° C for up to 12 hours. The current
cleared indication
further states that when using the device, "Donor hearts exceeding clinically accepte
d static hypothermic
preservation times should be evaluated by the transplant surgeon to determine transpl
antability in accordance
with accepted clinical guidelines and in the best medical interest of the intended re
cipient".
Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, "W
e are thrilled to
have received clearance of a second premarket notification from FDA for the Sherpa Pak
™ CTS. Following
excellent market reaction to our first 510(k) cleared product, we anticipate significan
t clinical interest for this
innovative technology in the markets where the Sherpa Pak™ CTS will be cleared for co
mmercial distribution.
This is the second in a series of regulatory pre-market clearances while we continue
our development of
several additional Sherpa CTS products."
Paragonix Technologies Inc., Announces Clearance of a Second 510(k) Premarket
Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac
Transport System
The Sherpa Pak™ Cardiac Transport System combines innovative cooling technology with
a safe,
consistent method for cold ischemic storage and transport of donor hearts to recipien
ts for
implantation.
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Leonard Golding
, MD, Chief Medical Officer at Paragonix, commented, "Clearance of a second
Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for
our Paragonix Sherpa
Pak™ CTS, is an important step towards introducing this technology into clinical prac
tice. The Sherpa Pak™
CTS will enable standardization of donor heart preservation and transportation."
Previous Announcements
Paragonix previously announced on January 27, 2014, presentation discussing the Sherp
a Perfusion™
Cardiac Transport System during the 2014 Cutting Edge of Transplantation Meeting.
Paragonix previously announced on December 18, 2013, closing of the Company's convert
ible $1.1M debt
financing.
Paragonix previously announced on December 17, 2013, filing of a 510(k) Pre-market Not
ification Application
with the US Food and Drug Administration for the Paragonix Sherpa™ Pak Transporter.
Paragonix previously announced on November 18, 2013, filing of a second 510(k) Pre-Mar
ket Notification
Application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardia
c Transport System.
Paragonix previously announced on July 22, 2013, Publication by the ASAIO (American S
ociety for Artificial
Internal Organs) Journal of "Oxygen Consumption during Oxygenated Hypothermic Perfusi
on as a Measure
of Donor Organ Viability"
Paragonix previously announced on June 10, 2013, Presentation of "An Innovative, Nove
l Hypothermic
Storage System For Donor Hearts," discussing the Sherpa Pak™ Cardiac Transport System
during the 16th
Congress of the European Society for Organ Transplantation held in Vienna, Austria, 8
th -- 11th September
2013
Paragonix previously announced on February 12, 2013, clearance of a 510(k) pre-market
ing notification
application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardia
c Transport System
Paragonix previously announced on July 16, 2012, award of a Phase I Small Business In
novation Research
(SBIR) Grant to support the pre-clinical development of the Paragonix Sherpa™ Cardiac
Transport in
collaboration with the Transplant Center at Massachusetts General Hospital (Boston).
Paragonix previously announced on June 25, 2012, Appointment of Leonard A. R. Golding
, MB, BS, FRACS,
FRCS(C), FACC as Chief Medical Officer.
Paragonix previously announced on June 18, 2012, Formation of a Clinical Advisory Boa
rd for the Paragonix
Sherpa™ Cardiac Transport System.
About the Paragonix Sherpa Pak™ Cardiac Transport System and the Sherpa Perfusion™ Ca
rdiac
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Transport System
The Sherpa Pak™ CTS is intended to provide a safe, consistent method for cold ischemi
c storage and
transport of donor hearts to recipients for implantation. The Sherpa Pak™ CTS is inte
nded for transport of
hearts within the time frame currently considered as routine medical practice.
Currently, however, the availability of cardiac transplantation is governed by the "i
schemic time", that being,
the elapsed time from heart donation to recipient implantation. According to The Inte
rnational Society Of Heart
and Lung Transplantation ("ISHLT") guidelines
for the care of heart transplant recipients, the projected
ischemic time should not exceed 4 hours
,
, limiting the distance available to transport a donor heart. The
Sherpa Perfusion™ Cardiac Transport System under development combines innovative oxyg
enated perfusion
of organs and safe organ storage with the goal of extending ischemic time to 12 hours
, significantly altering
the transportation range of donor hearts. As with its predecessor the Sherpa Cardiac
Transport System,
Sherpa Perfusion™ is designed to be used in conjunction with any of the currently ava
ilable organ
preservation solutions indicated for use with donor hearts and is fully disposable, e
liminating problems
associated with maintenance, device transport and contamination.
About the Cardiac Transplantation Market
Cardiac transplantation is considered the gold standard therapy for patients in end-s
tage heart failure.
With
over 5.8 million Americans currently diagnosed with heart failure (HF), growing at an
annual rate of 400,000
per year
, there is a persistent need to provide end-stage heart failure support to this expan
ding population.
Estimates of the prevalence of symptomatic HF in the general European population are
similar to those in the
United States.
The annual economic burden of treating heart failure exceeds
$34.4 billion
, over 50% of
which is due to the cost of hospitalization.
The financial demands associated with transplantation are
considerable. The estimated first year costs for heart transplant are $997,700, and su
bsequent annual costs
can easily exceed $30,000
. 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 l
ist for a heart transplant
.
Based on 2011 data, just over 2,300 patients will receive a live-saving transplant ea
ch 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 tra
nsplantation
,
maximization of donor organ utilization has enormous potential in cardiac transplanta
tion.
About Paragonix Technologies, Inc.,
Based in Braintree, Massachusetts and founded in 2010, Paragonix Technologies Inc., i
s a privately held
medical device company innovating the Paragonix Sherpa™ Cardiac Transport System. In
addition to the
products cleared for market, the company is developing a novel, single-use organ pres
ervation device to
improve donor organ quality and extend donor organ preservation times
;
Sherpa Perfusion™ Cardiac
Transport System combines innovative oxygenated perfusion of organs and safe organ st
orage with the goal
of extending ischemic time to 12 hours, significantly altering the transportation rang
e of donor hearts.
Paragonix has exclusively licensed University of Texas Health Science Center San Anto
nio intellectual
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