Paragonix Technologies Inc., Announces Filing Of A 510(k) Pre-Marketing Notification Application With FDA For The Paragonix Sherpa™ Pak Transporter
Paragonix Technologies, Inc. today announced that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Sherpa Pak™ Transporter1,2. The Sherpa Pak™ Transporter is indicated for the static hypothermic preservation of kidneys during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the kidney.
Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, “We are excited to have filed a Pre-Marketing Notification Application (510(k)) with FDA for the Sherpa Pak™ Transporter. This 510(k) pre-market application, when cleared by FDA, 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™ Transporter will be cleared for commercial distribution. This is the third in a series of regulatory applications while we continue our development of several additional Sherpa products.”
A. Benedict Cosimi, MD3 (Chief Emeritus, Department of Transplantation, Massachusetts General Hospital, Boston; Professor of Surgery at Harvard Medical School) commented, “I have devoted many decades to the science and clinical aspects of kidney transplantation. There has been, and continues to be, a persistent shortage of organs suitable for transplantation. Improvements in kidney preservation methods would greatly benefit the field. I am excited, therefore, to see advances such as these reach the pre-market submission stage.”
About A. Benedict Cosimi, MD
Dr. Cosimi is the Claude E. Welch Professor of Surgery at Harvard Medical School and Chief Emeritus of the Transplantation Unit at the Massachusetts General Hospital. He is the Past-President of the New England Surgical Society, President of the American Society of Transplant Surgeons as well as President of the 2006 World Transplantation Congress. He also currently on the Scientific Advisory Boards for the American Liver Foundation, the Massachusetts Kidney Foundation, and several biotechnology research foundations.
Previous Announcements
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 Sherpa™ is 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™ CTS is intended for transport of hearts and the Sherpa Pak™ Transporter is intended for transport of kidneys 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, improving donor organ quality and extending donor organ transport 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. Cosimi is a member of the Paragonix Scientific Advisory Board.
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/
Contacts
Paragonix Technologies Inc.
Bill Edelman, 781-436-0509
Chairman of the Board
bill@paragonixtechnologies.com
www.paragonixtechnologies.com
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