Paragonix Technologies Inc. Extends its Product Portfolio

Paragonix Technologies Inc. has expaned 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 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 barotrauma,³ the latter of which results from pressure changes in the lung during transport. Only one out of every five lungs (20 percent) donated in the United States 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, M.D., 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. “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,” Keller said. “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 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, Mass.), a Harvard Medical School Teaching hospital.
 
Jeff Goldstein, president and founding member of The Lung Transplant Foundation, “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.”
 
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, N.C. 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.

Lisa Anderson, Ph.D., president and chief operating officer for Paragonix said, “We are looking forward to working with a 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.”
 
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.
 
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 people 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 percent 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 more than $1 million, respectively.⁹ The costs for donor lung procurement are estimated at $90,000 to $130,000, respectively.¹⁰
 
Based in Braintree, Mass., and founded in 2010, Paragonix Technologies Inc. is a privately held medical device company innovating the Paragonix SherpaPak and SherpaPerfusion Transport System, a 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.

References
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”