Paragonix Initiates Global Post Market Registry Evaluating Clinical Outcomes in Patients who Receive Donor Hearts Transported with Paragonix SherpaPak™ Cardiac Transport System

Only FDA-Cleared and CE-Marked System for Donor Heart Transport

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix
Technologies, Inc.
today announced the opening of the Global
Utilization And Registry Database for Improved heArt preservatioN
(“GUARDIAN”) post-market registry, which will assess clinical outcomes
when employing the Paragonix
SherpaPak™ Cardiac Transport System (CTS)
for heart transplantations.

“Clinical feedback regarding the Paragonix SherpaPak™ CTS has been
extremely encouraging and we firmly believe we are on the path to
improve the standard of care in how donor hearts are transported,”
commented Dr. Lisa Anderson, President and Chief Operating Officer of
Paragonix. “An investment in a global registry reflects our commitment
to patients as well as to the clinical community who have embraced the
Paragonix SherpaPak™ CTS as a means of advancing donor heart
preservation and transport. Based on ongoing clinical observations, we
believe that a comparison to existing organ transport methods of a
conventional cooler with ice will further reveal the exciting benefits
of Paragonix SherpaPak™ CTS.”

About the GUARDIAN Registry

The registry study will include multiple transplant centers across the
U.S. and Europe. The primary objectives of the post-market registry
study are to evaluate short term post-transplant outcomes (within the
first 48 hours), intermediate term outcomes (within the first 30 days)
and long-term outcomes (1 year survival). There will be no changes to
existing standard protocols involved in donor heart transplantation. The
registry study will also further analyze the impact of a variety of
donor, recipient and transport-related parameters on patient outcomes,
including donor clinical backgrounds, total ischemic times and recipient
factors. For people interested in learning more about the GUARDIAN
registry, please contact info@guardianheartregistry.com.

“We will continue to evaluate the Paragonix SherpaPak™ CTS for donor
heart preservation,” said Dr. David D’Alessandro, Surgical Director for
Heart Transplantation at Massachusetts General Hospital. “Contributing
to GUARDIAN is an important step in that process.”

“Temperature control is a critical aspect of the organ transportation
process and with the Paragonix SherpaPak™ CTS we are able to remotely
monitor the temperature of the organ through the journey to the
recipient patient, thereby safeguarding the organ from cold injury,”
said Dr. Andreas Zuckermann, Principal Investigator of GUARDIAN and
Co-Director of Heart Transplantation at AKH Vienna, Austria. “We have
been an early adopter of the Paragonix SherpaPak™ CTS and it is an honor
to kick off this important registry.”

About the Paragonix SherpaPak™ Cardiac Transport System

The Paragonix SherpaPak™ Cardiac Transport System (CTS) safeguards
hearts during the journey from donor to recipient patient. Our device
incorporates clinically proven and medically trusted cold preservation
techniques in a novel suspension system to provide unprecedented
physical and thermal protection. Paragonix SherpaPak™ CTS is the only
commercially available FDA cleared and CE marked medical device for
heart transportation. More than 35 transplant centers throughout the
world are trained to use the Paragonix SherpaPak™ CTS for donor heart
transport. The System is currently marketed in the United States, United
Kingdom, France, Spain, Italy, Germany, Austria, Sweden, Switzerland,
Slovak Republic and The Netherlands.

About Paragonix Technologies, Inc.

Paragonix Technologies markets organ transportation devices that
safeguard organs during the journey between donor and recipient
patients. Our devices incorporate clinically proven and medically
trusted cold preservation techniques in a novel suspension system to
provide unprecedented physical and thermal protection. Paragonix
SherpaPak™ CTS is the only commercially available FDA cleared and CE
marked transport device for heart transportation. Paragonix is also
developing transport devices for the lung and kidneys designed to
improve donor organ quality and extending donor organ transport time.

Contacts

For Paragonix Technologies, Inc.:
Bill Edelman
781-436-0509
bill@paragonixtechnologies.com
www.paragonixtechnologies.com

Media Contact:
Lauren Arnold
MacDougall
781-235-3060
larnold@macbiocom.com