Paragonix Technologies, Inc. Announces Partnership with the Lung Transplant Foundation to Support Commercialization of Paragonix SherpaLung™ for Improved Donor Lung Transport

Paragonix SherpaLung™ is the Company’s latest innovative advancement to its donor organ transport portfolio. Based on the similar single-use, continuous monitoring and validated temperature control product design of the Paragonix SherpaPak™ Cardiac and Kidney Transport System, Paragonix SherpaLung™ is a unique, easy-to-use transport device to ensure optimal and cost effective donor lung preservation between organ recovery and transplantation.

The Paraognix SherpaLung™ 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, especially relevant during aircraft transport. Based on the current method of lung preservation and transportation, only one out of every five lungs (20%) donated in the U.S. can be used for transplantation.⁴ To uniquely address this critical need, the Paragonix SherpaLung™ 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.

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. Paragonix has developed Paragonix SherpaLung™ for the safe storage and transport of precious donor lungs destined for transplantation. The Paragonix approach to organ preservation is innovative and finally addresses the clinical needs for donor lung transportation. We are so incredibly excited about partnering with Paragonix Technologies to support these efforts.”

Dr. Matthew Hartwig, Associate Professor of Surgery, Duke Medical Center, Cardiovascular and Thoracic Surgery, and a lung transplant surgeon, stated: “An intuitive product to protect precious donor lungs during transport is critically needed. Every donor lung recovered from an organ donor should be monitored and controlled during transport from organ recovery to the transplant recipient. I look forward to evaluating Paragonix SherpaLung™ in the clinic.”

Bill Edelman, Chairman & CEO, for Paragonix commented, “We have found an incredibly supportive partner in The Lung Transplant Foundation. We are grateful and honored by the support of this incredible group of lung transplant recipients who have made it their goal to contribute to the field of lung transplantation. We are excited to see the support of Paragonix SherpaLung™ from the clinical community in the United States and in Europe.”

Previous Announcements

Paragonix previously announced April 3, 2018 Presentation of the SherpaPak™ Cardiac Transport Systems and SherpaPerfusion™ Cardiac Transport System at the 38th Annual Meeting of the International Society for Heart and Lung Transplantation (Nice, France, April 11 – 14, 2018).

Paragonix previously announced March 26, 2018 Appointment of Carl Rickenbaugh to the Board of Directors.

Paragonix previously announced February 20, 2018 European Conformity (“CE”)⁵ Premarket Clearance for the SherpaPak™ Cardiac Transport System and SherpaPerfusion™ Cardiac Transport System Family of Organ Transport Products.

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 and Kidney Transport Systems

Currently, the availability of transplantation is governed by the “ischemic time”, that being, the elapsed time from donation to recipient implantation. Paragonix SherpaPak^™ System 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 failure⁶ 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.⁷ 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.⁸ 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.⁹ The direct and indirect costs for single and double lung transplantation is estimated at $790,000 and over $1M, respectively.¹⁰ The costs for donor lung procurement are estimated at $90,000 - $130,000, respectively.¹¹

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™, Paragonix SherpaPerfusion™ Transport Systems and Paragonix SherpaLung™, which are novel, single-use organ preservation devices 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 The CE mark (Conformité Européenne, meaning “European Conformity,” formerly EC mark) according to the European Medical Directive (MDD) is a mandatory conformity mark for medical devices placed on the market in the European Economic Area (EEA). With the CE marking on a medical device, the manufacturer ensures that the product conforms to the essential requirements of the applicable EC medical device directives.
⁶ J Thorac Dis. 2010 Jun; 2(2): 111–116.
⁷ Orphanet J Rare Dis. 2008; 3: 8.
⁸ http://www.who.int/respiratory/copd/burden/en/
⁹ https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/
¹⁰ http://www.transplants.org/faq/how-much-does-transplant-cost
¹¹ Milliman Research Report, “2014 US Organ and Tissue Transplant Cost Estimates and Discussion”

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