Paragonix Technologies Inc., Announces Presentation of the SherpaPak™ Cardiac Transport System during the 2016 American Transplant Congress June 11 - 15, 2016 in Boston, MA.

The Sherpa Pak™ Cardiac Transport System combines innovative cooling technology with a safe, consistent method for cold ischemic storage and transport of donor organs

BOSTON--()--Paragonix Technologies, Inc. today announced plans to present the SherpaPak™ Cardiac Transport System during the 2016 American Transplant Congress to be held at the Hynes Convention Center, Booth 1216, in Boston from June 11 - 15, 2016. The SherpaPak™ Cardiac Transport System1,2 combines innovative cooling technology with a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for implantation. The 2016 American Transplant Congress is the Joint Annual Meeting of the American Society of Transplant Surgeons and the American Society of Transplantation.

Bill Edelman, CEO and Chairman, for Paragonix commented, “We are looking forward to introducing the SherpaPak™ Cardiac Transport System to the clinical community during the upcoming 2016 American Transplant Congress. Recent market feedback studies suggest continuing demand and support for this innovative technology. The Paragonix SherpaPak devices for kidney and heart preservation are an important step in improving donor organ transportation. We believe that improving the utilization of donated hearts is critical to patients in end-stage heart failure who are desperate for this precious commodity.”

Previous Announcements

Paragonix previously announced on July 23, 2015, Publication of “Innovative Cold Storage Of Donor Organs Using The Paragonix SherpaPak™ Devices"3

Paragonix previously announced on February 9, 2015, Innovative Tracking Technology For Real-Time, National Location Tracking of Donor Organs

Paragonix previously announced on December 2, 2014, clearance of two 510(k) Premarket Notifications by the US Food and Drug Administration, allowing the Paragonix Sherpa Pak Transport Systems to be combined and distributed with any FDA-cleared, commercially-available preservation solution.

Paragonix previously announced on Nov 17, 2014, Receipt of ISO 13485:2003 Certification for the Paragonix Sherpa Organ Storage and Transport Systems

Paragonix previously announced on Nov 3, 2014, filing of two 510(k) FDA Pre-Market Notifications to combine the Paragonix Sherpa Pak Cardiac and Kidney Transport Systems with any effective organ preservation solution currently marketed under 510(k) Pre-market Clearance

Paragonix previously announced on Oct 27, 2014, joining of David D’Alessandro, MD, as Medical Director for Paragonix

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 American Society of Transplantation

The American Society of Transplantation (AST) represents more than 3,500 transplantation professionals dedicated to advancing the field and improving patient care by promoting research, education, advocacy, and organ donation. The AST’s diverse membership includes physicians, surgeons, scientists, nurses, allied health professionals, and administrators.

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”) guidelines4 for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours5,6, 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.7 With over 5.8 million Americans currently diagnosed with heart failure (HF), growing at an annual rate of 400,000 per year8, 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.9 The annual economic burden of treating heart failure exceeds $34.4 billion10, over 50% of which is due to the cost of hospitalization.11 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 $30,00012. 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 list for a heart transplant13. Based on 2011 data, just over 2,300 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 transplantation14, 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 ShepaPak™ Cardiac Transport System is protected by patents, both issued and pending

2 The ShepaPak™ Cardiac Transport System has received FDA 510(k) pre-market clearance

3 Michel et al. Heart, Lung and Vessels; 2015;7(3):246-55

4 ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)

5 J Heart Lung Transplant 2001; 20(2):212.

6 J Am Coll Cardiol 2004; 43(9):1553-1561.

7 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

8 Circulation 2010;121:e46-e215

9 http://about.datamonitor.com/media/archives/314

10 Circulation 2011;123(8):933-944

11 Circulation 2007;115(5)

12 http://www.transplantliving.org

13 http://optn.transplant.hrsa.gov

14 http://www.uptodate.com/contents/heart-transplantation-beyond-the-basics

Contacts

Paragonix Technologies Inc.
Bill Edelman, 781-436-0509 o/c
bill@paragonixtechnologies.com
www.paragonixtechnologies.com

Release Summary

Paragonix Technologies Inc., Announces Presentation of the SherpaPak™ Cardiac Transport System during the 2016 American Transplant Congress June 11 - 15, 2016 in Boston, MA.

Contacts

Paragonix Technologies Inc.
Bill Edelman, 781-436-0509 o/c
bill@paragonixtechnologies.com
www.paragonixtechnologies.com