Paragonix Technologies Inc. Announces Extension Of Product Portfolio With The Addition Of Sherpapak Lung Transport System

BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced expansion of its existing product portfolio of organ preservation and transport devices with the addition of SherpaPak™ Lung Transport System^1,2. The SherpaPak™ Lung Transport System combines optimal homogenous hypothermic cooling with dynamic equilibration of lung airway pressure and organ parameter monitoring during storage and transport of donor lungs to recipients for implantation. Based on the similar single-use, disposable product strategy of the Paragonix SherpaPak™ Cardiac and Kidney Transport System, SherpaPak™ Lung Transport System is a unique, easy-to-use transport device to ensure optimal donor lung preservation between organ recovery and transplantation. The SherpaPak™ Lung Transport System aims to prevent and limit organ injury that occurs during conventional ice storage due to excessively cold temperatures and barotrauma³, the latter of which results from pressure changes in the lung during transport. Only one out of every five lungs (20%) donated in the U.S. can be used for transplantation based on the current method of lung preservation and transportation.⁴

The Paragonix Team will be advised by pulmonary expert Dr. Steven Keller, MD, Ph.D., who specializes in lung transplantation and critical care medicine at Brigham and Women’s Hospital and is on faculty at the Harvard-MIT Biomedical Engineering Center, where his work is focused on artificial organ support technologies. Dr. Keller commented. “As a lung transplant pulmonologist and biomedical engineer, I believe that optimal preservation of the donor lung is extremely important for the long term outcome of lung transplant recipients. I believe that much of the morbidity associated with the peri-transplant clinical course can be directly attributed to sub-optimally preserved donor organs. A cost-effective and easy-to-use transport system to ensure best possible preservation of donor lungs is critically needed. To achieve this, it is paramount to address both temperature and pressure-related issues that can negatively impact donor lung quality during transport. I believe that a system aimed at improving lung transport will greatly enhance organ quality. ”

In addition to Dr. Keller, Paragonix’s Sherpa Lung Team will be supported by Dr. Hari Mallidi, who is the Co-Director for Lung Transplant, ECMO and Lung assist devices within the Surgical Program in Heart and Lung Transplantation and Mechanical and Circulatory Support at the Brigham and Women’s Hospital (Boston), a Harvard Medical School Teaching Hospital.

Jeff Goldstein, President and Founding Member of The Lung Transplant Foundation commented, “Our mission at The Lung Transplant Foundation is to promote and advance research in order to improve long-term outcomes among lung transplant recipients and to educate and promote awareness about organ donation. As a lung transplant recipient, I believe current methods of transportation and preservation of an extremely precious donor lung must be improved. The lung transplant field is in critical need of easy-to-use and effective preservation devices for the transport of lungs between organ donation and implantation.”

Lisa Anderson, PhD, President and COO, for Paragonix commented, “We are looking forward to working with a world-class team, all of whom bring incredibly valuable clinical experience to the Sherpa™ Lung Advanced Technology Expert Team. We are excited to expand our Sherpa™ platform with SherpaPak™ Lung Transport System.”

Previous Announcements
Paragonix previously announced April 24, 2017 Presentation of the SherpaPak™ Organ Transport Systems at the American Transplant Congress (ATC) (Chicago, April 29 – May 3, 2017).

Paragonix previously announced March 27, 2017 Presentation of the SherpaPak™ Organ Transport Systems and SherpaPerfusion™ Cardiac Transport System at the 37th Annual Meeting of the International Society for Heart and Lung Transplantation (San Diego, 5 – 8 April 2017).

Paragonix previously announced February 7, 2017 an exclusive distribution agreement with MBA Medical to market Paragonix Technologies’ SherpaPak™ Cardiac and Kidney Transport Systems, in the Southern United States.

Paragonix previously announced January 9, 2017 a Presentation of the SherpaPak™ Organ Transport Systems during the ASTS 17^th Annual State of the Art Winter Symposium January 26 to 29, 2017 in Miami, FL.

Paragonix previously announced January 4, 2017 an exclusive supply agreement with Sanbor Medical for the Manufacture and Assembly of SherpaPak™ Organ Transport Systems.

About The Lung Transplant Foundation
In June 2009, the national Lung Transplant Foundation (LTF) was founded as a non-profit organization by a group of lung transplant recipients from Durham and Chapel Hill, NC. These recipients from Duke University and UNC Hospitals realized promotion and funding of research to improve the post lung transplant experience and long term outcomes was severely lacking, so they created the LTF to tackle one of the most difficult and life-threatening issues facing transplant recipients, chronic rejection or bronchiolitis obliterans syndrome (BOS). The LTF now includes a Board of Directors comprised of lung transplant recipients, caregivers and connected individuals who graciously donate their time to further the mission of the LTF. What began as a small foundation has grown to become an outspoken advocate for the advancement of research to cure BOS and one of the most widely recognized organizations promoting lung transplant as a viable alternative to end-stage lung disease.

About the Paragonix SherpaPak™ and SherpaPerfusion™ Cardiac Transport System
Currently, the availability of transplantation is governed by the “ischemic time”, that being, the elapsed time from donation to recipient implantation. Paragonix SherpaPak™ is fully disposable, eliminating problems associated with maintenance, device transport and contamination. The Paragonix SherpaPerfusion™ System combines innovative oxygenated perfusion of organs and safe organ storage with the ultimate goal of extending ischemic time, significantly altering the transportation range of donor organs.

About the Lung Transplantation Market
Lung transplantation is considered gold standard therapy for patients in end-stage pulmonary failure⁵ due to Idiopathic Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease. Idiopathic pulmonary fibrosis (IPF) is a non-neoplastic pulmonary disease that is characterized by the formation of scar tissue within the lungs in the absence of any known provocation. IPF is a rare disease which affects approximately 5 million persons worldwide.⁶ Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with various clinical presentations. The basic abnormality in all patients with COPD is airflow limitation. COPD is a major public health problem. According to WHO estimates, 65 million people have moderate to severe chronic COPD. More than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally.⁷ According to data from the Organ Procurement and Transplantation Network, there have been more than 34,000 lung transplants completed in the United States since 1988. In 2016 2,400 lung transplants took place. The majority of those surgeries were in patients age 18 to 64 years old.⁸ The direct and indirect costs for single and double lung transplantation is estimated at $790,000 and over $1M, respectively.⁹ The costs for donor lung procurement are estimated at $90,000 - $130,000, respectively.¹⁰

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™ 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 SherpaPak™ Lung Transport System and the SherpaPak™ product line are protected by patents, both issued and pending.

² The SherpaPak™ Lung Transport System is not approved for sale in the U.S.

³ Ann Thorac Surg. 2010 May; 89(5): 1555–1562.

⁴ Organ Procurement and Transplant Network, http://optn.transplant.hrsa.gov

⁵ J Thorac Dis. 2010 Jun; 2(2): 111–116.

⁶ Orphanet J Rare Dis. 2008; 3: 8.

⁷ http://www.who.int/respiratory/copd/burden/en/

⁸ https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/

⁹ http://www.transplants.org/faq/how-much-does-transplant-cost

¹⁰ Milliman Research Report, “2014 US Organ and Tissue Transplant Cost Estimates and Discussion”