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Paragonix Technologies Inc., Announces Clearance of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Paragonix Sherpa Pak™ Kidney Transport System

Companies mentioned in this article: Paragonix Technologies, Inc.

BRAINTREE, Mass. -- (BUSINESS WIRE) -- Paragonix Technologies, Inc. today announced that it received clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Sherpa Pak™ Kidney Transport System1,2. The Sherpa Pak™ Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with this organ. The Sherpa Pak™ Kidney Transport System can maintain donor organ storage temperature between 4°C and 8°C through 24 hours.

Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, “We are excited to have received clearance of a Pre-Marketing Notification (510(k)) from FDA for the Sherpa Pak™ Kidney Transport System. This 510(k) clearance will expand our product portfolio of organ preservation technologies. Following excellent market reaction to our Sherpa Pak™ Cardiac Transport System, we anticipate significant clinical interest for this innovative technology in the markets where the Sherpa Pak™ Kidney Transport System will be cleared for commercial distribution. This is the third in a series of regulatory clearances while we continue our development of several additional Sherpa products.”

Stefan G. Tullius3, MD, PhD, (Professor of Surgery, Harvard Medical School &Chief, Division of Transplant Surgery, Brigham and Women's Hospital, Boston) commented, "Organ preservation and effective means of transportation are key elements in managing clinical outcomes when dealing with patients requiring life saving organ transplantation. The Sherpa Pak™ Kidney Transport System has a temperature display and a timer used to monitor the organ storage temperature in real time and to display time elapsed during transport, respectively. Using innovative cooling technology, the System maintains the organ at the optimal storage temperature range of 4-8°C. In contrast, the conventional ice storage method can result in undesirable, and potentially injury-inducing temperatures of 0°C and below, within hours of organ storage. It is exciting to see the Sherpa Pak™ Kidney Transport System gain FDA pre-market clearance. I look forward to seeing this technology in the clinic."

About Stefan G. Tullius, MD, PhD

Dr. Tullius, Professor of Surgery at Harvard Medical School in Boston, Ma. is the Chief of Transplant Surgery & Director of the Transplant Surgery Research Laboratory at Brigham and Women's Hospital. The Transplant Surgery Research Laboratory (TSRL) investigates basic mechanisms of clinically relevant aspects in organ transplantation focusing on novel routes for the improvement of organ quality and an individualized immunosuppression.

Previous Announcements

Paragonix previously announced on February 24, 2014, clearance of a second 510(k) Premarket Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

Paragonix previously announced on December 18, 2013, closing of a $1.1M Convertible Debt Financing

Paragonix previously announced on December 17, 2013, filing of a third 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Pak Transporter

Paragonix previously announced on November 18, 2013, the filing of a second 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

Paragonix previously announced on July 22, 2013, Publication by the ASAIO (American Society for Artificial Internal Organs) Journal of "Oxygen Consumption during Oxygenated Hypothermic Perfusion as a Measure of Donor Organ Viability"

Paragonix previously announced on June 10, 2013, Presentation of "An Innovative, Novel 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, 8th – 11th September 2013

Paragonix previously announced on February 12, 2013, clearance of a 510(k) pre-marketing notification application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

Paragonix previously announced on July 16, 2012, award of a Phase I Small Business Innovation 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 Board for the Paragonix Sherpa™ Cardiac Transport System.

About the Paragonix Sherpa™ Technology

Currently, the availability of organs for transplantation is governed by the “ischemic time”, that being, the elapsed time from organ donation to recipient implantation. Paragonix Sherpa is designed to be used in conjunction with any of the currently available organ preservation solutions. Paragonix Sherpais fully disposable, eliminating problems associated with maintenance, device transport and contamination. Paragonix Sherpa is intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for implantation. The Sherpa Pak™ Kidney Transport System is intended for transport of kidneys and the Sherpa Pak™ Cardiac Transport System is intended for transport of hearts within the time frame currently considered as routine medical practice.

About the Kidney Transplant Market

Kidney transplantation is considered the most desired and cost-effective treatment solution for patients in end-stage renal disease (ESRD)4. The only alternative treatment for this patient population is life-long hemodialysis. Over 500,000 Americans are currently diagnosed with ESRD5. The annual economic burden of treating ESRD is estimated to be over $40 billion/year6. While the costs of a kidney transplant are substantial (approximately $262,9007), the yearly costs for treating a patient on hemodialysis are nearly three times the costs for treating a transplant patient8.

As of November 30, 2013, approximately 100,000 patients in the United States are on the waiting list for a kidney transplant9. Based on 2012 data, just over 16,500 patients received a kidney transplant (11,000 from deceased donor and 5,600 from living donors)10, which is reflective of the enormous donor heart shortage. Upon organ recovery, donor kidneys are either stored on ice (static cold storage or “SCS”) or are preserved until transplantation employing hypothermic machine perfusion (“HMP”). Approximately 30% of cadaver kidneys are stored on HMP, the balance is preserved using SCS.

About Paragonix Technologies, Inc.

Based in Braintree, Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix Sherpa™, a novel, single-use organ preservation device. Paragonix has exclusively licensed University of Texas Health Science Center San Antonio intellectual property from the Office of Technology Transfer and Commercialization. Paragonix has established a pipeline of donor organ transport devices that address the current donor organ shortage by maximizing donor organ utilization and improving donor organ quality throughout the entire United States.

1 On February 6, 2013, FDA cleared for commercial distribution the Sherpa Pak™ Cardiac Transport System 510(k) pre-market submission.

2 Patents pending.

3 Dr. Tullius is a Member of the Scientific Advisory Board for Paragonix Technologies, Inc.

4 http://cjasn.asnjournals.org/content/3/2/471.full

5 http://www.usrds.org/2013/slides/indiv/v2index.html

6 http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/#1

7 http://us.milliman.com/insight/research/health/2011-U_S_-organ-and-tissue-transplant-cost-estimates-and-discussion/

8 http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/#1

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

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


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Contact:

Paragonix Technologies Inc.
Bill Edelman, 781-436-0509
Chairman of the Board
bill@paragonixtechnologies.com
www.paragonixtechnologies.com