fbpx

Paragonix Technologies, Inc. Announces Partnership with the Lung Transplant Foundation to Support Commercialization of Paragonix SherpaLung for Improved Donor Lung Transport

Paragonix Technologies, Inc. today announced a partnership with the Lung
Transplant Foundation to support the Company’s further development and
subsequent commercialization of Paragonix SherpaLung1,2, a
donor lung transport device for improved lung preservation and
transportation.

Paragonix SherpaLung™ is the Company’s latest innovative advancement to
its donor organ transport portfolio. Based on the similar single-use,
continuous monitoring and validated temperature control product design
of the Paragonix SherpaPak™ Cardiac and Kidney Transport System,
Paragonix SherpaLung™ is a unique, easy-to-use transport device to
ensure optimal and cost effective donor lung preservation between organ
recovery and transplantation.

The Paraognix SherpaLung™ aims to prevent and limit organ injury that
occurs during conventional ice storage due to excessively cold
temperatures and barotrauma3, the latter of which results
from pressure changes in the lung, especially relevant during aircraft
transport. Based on the current method of lung preservation and
transportation, only one out of every five lungs (20%) donated in the
U.S. can be used for transplantation.4 To uniquely address
this critical need, the Paragonix SherpaLung™ combines optimal
homogenous hypothermic cooling with dynamic equilibration of lung airway
pressure and organ parameter monitoring during storage and transport of
donor lungs to recipients for implantation.

Jeff Goldstein, President and Founding Member of The Lung Transplant
Foundation commented, “Our mission at The Lung Transplant Foundation is
to promote and advance research in order to improve long-term outcomes
among lung transplant recipients and to educate and promote awareness
about organ donation. As a lung transplant recipient, I believe current
methods of transportation and preservation of an extremely precious
donor lung must be improved. The lung transplant field is in critical
need of easy-to-use and effective preservation devices for the transport
of lungs between organ donation and implantation. Paragonix has
developed Paragonix SherpaLung™ for the safe storage and transport of
precious donor lungs destined for transplantation. The Paragonix
approach to organ preservation is innovative and finally addresses the
clinical needs for donor lung transportation. We are so incredibly
excited about partnering with Paragonix Technologies to support these
efforts.”

Dr. Matthew Hartwig, Associate Professor of Surgery, Duke Medical
Center, Cardiovascular and Thoracic Surgery, and a lung transplant
surgeon, stated: “An intuitive product to protect precious donor lungs
during transport is critically needed. Every donor lung recovered from
an organ donor should be monitored and controlled during transport from
organ recovery to the transplant recipient. I look forward to evaluating
Paragonix SherpaLung™ in the clinic.”

Bill Edelman, Chairman & CEO, for Paragonix commented, “We have found an
incredibly supportive partner in The Lung Transplant Foundation. We are
grateful and honored by the support of this incredible group of lung
transplant recipients who have made it their goal to contribute to the
field of lung transplantation. We are excited to see the support of
Paragonix SherpaLung™ from the clinical community in the United States
and in Europe.”

Previous Announcements

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”)5 Premarket Clearance for the SherpaPak™ Cardiac
Transport System and SherpaPerfusion™ Cardiac Transport System Family of
Organ Transport Products.

About The Lung Transplant Foundation

In June 2009, the national Lung Transplant Foundation (LTF) was founded
as a non-profit organization by a group of lung transplant recipients
from Durham and Chapel Hill, NC. These recipients from Duke University
and UNC Hospitals realized promotion and funding of research to improve
the post lung transplant experience and long term outcomes was severely
lacking, so they created the LTF to tackle one of the most difficult and
life-threatening issues facing transplant recipients, chronic rejection
or bronchiolitis obliterans syndrome (BOS).

The LTF now includes a Board of Directors comprised of lung transplant
recipients, caregivers and connected individuals who graciously donate
their time to further the mission of the LTF. What began as a small
foundation has grown to become an outspoken advocate for the advancement
of research to cure BOS and one of the most widely recognized
organizations promoting lung transplant as a viable alternative to
end-stage lung disease.

About the Paragonix SherpaPak™ and SherpaPerfusion™ Cardiac and
Kidney Transport Systems

Currently, the availability of transplantation is governed by the
“ischemic time”, that being, the elapsed time from donation to recipient
implantation. Paragonix SherpaPak™ System is fully
disposable, eliminating problems associated with maintenance, device
transport and contamination. The Paragonix SherpaPerfusion™
System combines innovative oxygenated perfusion of organs and safe organ
storage with the ultimate goal of extending ischemic time, significantly
altering the transportation range of donor organs.

About the Lung Transplantation Market

Lung transplantation is considered gold standard therapy for
patients in end-stage pulmonary failure6 due to Idiopathic
Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease. Idiopathic
pulmonary fibrosis (IPF) is a non-neoplastic pulmonary disease that is
characterized by the formation of scar tissue within the lungs in the
absence of any known provocation. IPF is a rare disease which affects
approximately 5 million persons worldwide.7 Chronic
obstructive pulmonary disease (COPD) is a heterogeneous disease with
various clinical presentations. The basic abnormality in all patients
with COPD is airflow limitation. COPD is a major public health problem.
According to WHO estimates, 65 million people have moderate to severe
chronic COPD. More than 3 million people died of COPD in 2005, which
corresponds to 5% of all deaths globally.8 According to data
from the Organ Procurement and Transplantation Network, there have been
more than 34,000 lung transplants completed in the United States since
1988. In 2016 2,400 lung transplants took place. The majority of those
surgeries were in patients age 18 to 64 years old.9 The
direct and indirect costs for single and double lung transplantation is
estimated at $790,000 and over $1M, respectively.10 The costs
for donor lung procurement are estimated at $90,000 – $130,000,
respectively.11

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™, Paragonix SherpaPerfusion™ Transport Systems and Paragonix
SherpaLung™, 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 throughout the entire United
States.

1 The SherpaPak™ Lung Transport System and the SherpaPak™
product line are protected by patents, both issued and pending.2
The SherpaPak™ Lung Transport System is not approved for sale in the U.S.3
Ann Thorac Surg. 2010 May; 89(5): 1555–1562.4 Organ
Procurement and Transplant Network, http://optn.transplant.hrsa.gov5
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.6 J Thorac Dis. 2010 Jun; 2(2):
111–116.7 Orphanet J Rare Dis. 2008; 3: 8.8
http://www.who.int/respiratory/copd/burden/en/9
https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/10
http://www.transplants.org/faq/how-much-does-transplant-cost11
Milliman Research Report, “2014 US Organ and Tissue Transplant Cost
Estimates and Discussion”

View source version on businesswire.com: https://www.businesswire.com/news/home/20180618005320/en/