FDA Clears Paragonix Technologies’ LUNGguard for Donor Lung Preservation

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Paragonix Technologies Inc.today announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard1,2.

The Paragonix LUNGguard Donor Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for LUNGguard is up to 8 hours. Donor lungs 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.3

LUNGguard is designed to function with ease in the often extremely stressful, fast-paced environments of donor and transplant centers. The current standard-of-care for donor lungs is to package the lungs in a series of sterile bags placed on crushed ice without the ability to maintain, monitor and report environmental conditions of the organ. LUNGguard is designed to overcome current preservation limitations and provide reporting of preservation and transport data. LUNGguard will be commercially available to all US lung transplant centers in Q2 of 2020.

“Donor lungs for transplant are fragile, precious cargo that are by necessity packaged and transported over great distances. Quality management and control over the environmental conditions of the donor lung is critical to the success of the operation,” commented Matthew Hartwig, MD, lung transplant surgeon at Duke University Lung Transplant Program. “We are looking forward to evaluating this innovative technology in clinical practice and implementing additional quality management over the donor lung transport process using LUNGguard.”

“Patients on the lung transplant waitlist must be given every possible advantage in their journey of becoming a lung transplant recipient,” commented Jeff Goldstein, CEO of the Lung Transplant Foundation. “Based on my own experience as a lung transplant recipient, technologies are critically needed that support and complement the incredible clinical effort afforded by surgical teams and Organ Procurement Organizations as well as the wonderful gift from a donor family.”

“The recent addition of LUNGguard to our expanding portfolio of organ preservation devices serving all solid organs will provide an important tool for the transplant community,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “We are thrilled to contribute to improved lung preservation with LUNGguard.”

About Lung Transplantation
Lung transplantation is considered the gold standard therapy for patients in end-stage pulmonary failure4 due to pulmonary fibrosis, Chronic Obstructive Pulmonary Disease (COPD) and other underlying lung diseases. 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.5 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.6 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.7 The direct and indirect costs for single and double lung transplantation is estimated at $790,000 and over $1M, respectively.8 The costs for donor lung procurement are estimated at $90,000 – $130,000, respectively.9

Duke University Hospital
Duke University Hospital is a 957-acute care bed academic tertiary care facility located in Durham, North Carolina. Since its establishment in 1930, the hospital has grown from a small regional hospital to a world-renowned academic medical center. Duke University Medical Center is the group of patient care, education and medical research facilities on the medical campus of Duke University in Durham, NC. The Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Established in 1925 by James B. Duke, the School of Medicine has earned its reputation as an integral part of one of the world’s foremost patient care and biomedical research institutions.

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 LUNGguard
LUNGguard safeguards lungs during the journey from donor to recipient patient. Our device incorporates clinically proven and medically trusted cold preservation to provide unprecedented physical and thermal protection.

About Paragonix Technologies, Inc.
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques to provide unprecedented physical and thermal protection. Paragonix is marketing and developing transport devices for hearts, lungs, pancreas, livers and kidneys designed to improve donor organ quality and extending donor organ transport time.

1O, January 16, 2020, FDA cleared for commercial distribution the SherpaPak™ Lung Preservation System 510(k) pre-market submission.
2Patents pending.
3Partial lungs can be transported via the LUNGguard Donor Lung Preservation Device by packaging lungs per institutional protocol and UNOS guidelines.
4Thorac Dis. 2010 Jun; 2(2): 111–116.
5Orphanet J Rare Dis. 2008; 3: 8.
6http://www.who.int/respiratory/copd/burden/en/
7https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/
8http://www.transplants.org/faq/how-much-does-transplant-cost
9Milliman Research Report, “2014 US Organ and Tissue Transplant Cost Estimates and Discussion”

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Contacts
For Paragonix Technologies, Inc.:
Bill Edelman
781-436-0509
bill@paragonixtechnologies.com
www.paragonixtechnologies.com

Paragonix Technologies, Inc
245 First Street, 18th Floor
Cambridge, Massachusetts 02142
info@paragonixtechnologies.com