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TMCNet:  Paragonix Technologies Inc., Announces Clearance of a Second 510(k) Premarket Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

[February 24, 2014]

Paragonix Technologies Inc., Announces Clearance of a Second 510(k) Premarket Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

BRAINTREE, Mass. --(Business Wire)--

Paragonix Technologies, Inc. today announced that it has received clearance for its second Premarket Notification (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac Transport System1,2(CTS (News - Alert)).

The Sherpa Pak™ Cardiac Transport System is "intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Sherpa Pak Cardiac Transport System is up to 4 hours".

As described in the product's labeling, following assembly, the Sherpa Pak CTS™ is capable of maintaining cold storage solution temperature between 4° and 8° C for up to 12 hours. The current cleared indication further states that when using the device, "Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient".

Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, "We are thrilled to have received clearance of a second premarket notification from FDA for the Sherpa Pak™ CTS. Following excellent market reaction to our first 510(k) cleared product, we anticipate significant clinical interest for this innovative technology in the markets where the Sherpa Pak™ CTS will be cleared for commercial distribution. This is the second in a series of regulatory pre-market clearances while we continue our development of several additional Sherpa CTS products."

Leonard Golding3, MD, Chief Medical Officer at Paragonix, commented, "Clearance of a second Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for our Paragonix Sherpa Pak™ CTS, is an important step towards introducing this technology into clinical practice. The Sherpa Pak™ CTS will enable standardization of donor heart preservation and transportation."

Previous Announcements

Paragonix previously announced on January 27, 2014, presentation discussing the Sherpa Perfusion™ Cardiac Transport System during the 2014 Cutting Edge of Transplantation Meeting.

Paragonix previously announced on December 18, 2013, closing of the Company's convertible $1.1M debt financing.

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

Paragonix previously announced on November 18, 2013, filing of a second 510(k) Pre-Market 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 (News - Alert) of a Clinical Advisory Board for the Paragonix Sherpa™ Cardiac Transport System.

About the Paragonix Sherpa Pak™ Cardiac Transport System and the Sherpa Perfusion™ Cardiac Transport System

The Sherpa Pak™ CTS is intended to provide a safe, consistent method for cold ischemic storage and transport of donor hearts to recipients for implantation. The Sherpa Pak™ CTS is intended for transport of hearts within the time frame currently considered as routine medical practice.

Currently, however, 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. The Sherpa Perfusion™ Cardiac Transport System under development combines innovative oxygenated perfusion of organs and safe organ storage with the goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts. As with its predecessor the Sherpa Cardiac Transport System, Sherpa Perfusion™ is designed to be used in conjunction with any of the currently available organ preservation solutions indicated for use with donor hearts and is fully disposable, eliminating problems associated with maintenance, device transport and contamination.

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 Braintree, Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix Sherpa™ Cardiac Transport System. In addition to the products cleared for market, the company is developing a novel, single-use organ preservation device to improve donor organ quality and extend donor organ preservation times; Sherpa Perfusion™ Cardiac Transport System combines innovative oxygenated perfusion of organs and safe organ storage with the goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts. 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 first Sherpa Pak CTS 510(k) pre-market submission.
2 Patents issued and pending.
3 Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC, is on Staff in the Department of Biomedical Engineering at Cleveland Clinic and has a secondary appointment in the Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic's main campus.
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


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