Paragonix Technologies, Inc. and the Lung Transplant Foundation (LTF) today announced an expansion of their partnership for the development of a series of innovative technologies for improved donor lung preservation.
At a joint meeting held during the International Society for Heart and Lung Transplantation (ISHLT) 2019 Annual Meeting in Orlando, FL, The Lung Transplant Foundation reviewed how the 2017 OPTN/UNOS policy1 covering the distribution of lungs donated for transplant has impacted waitlist removal, logistical burden on organ procurement, distances traveled to retrieve lungs and overall lung retrieval costs. Notably, the updated policy expanded the geographical boundaries for lungs to travel, with first priority offered to patients within a 250-mile radius of the donor’s hospital and then expanding within 575 miles, and then finally across the nation if a matching patient cannot be found. The expanded travel distances results in organs needing to be stored longer, making it imperative that as little damage as possible is done to the organ during transit.
Paragonix is currently completing commercial development of the Paragonix SherpaLung™ Preservation System and expects the filing of FDA pre-market notification and European CE clearance by Q4 2019. The Paragonix SherpaLung™ Preservation System is designed to ensure optimal lung preservation during its journey from donor to recipient patient by incorporating medically proven and clinically validated preservation techniques combined with lung inflation pressure control, ensuring stable inflation pressure on the ground or during air transport.
Jeff Goldstein, CEO and Founding Member of the Lung Transplant Foundation, commented, “There is no more urgent time than now to provide those patients on the lung transplant waitlist with any possible advantage they can get. With longer travel distances observed since implementation of the new lung distribution policy, there is a desperate need for better lung preservation: improved and controlled donor lung preservation technologies that will take into account more extensive travel by aircraft.2 And we applaud Paragonix for developing these types of technologies that will also work in a cost-conscious healthcare environment.”
“We are entering a new paradigm of broader geographic sharing in solid organ transplantation, and current technologies for lung preservation do not adequately address the extensive travel and longer transport times experienced by most lung transplant centers in the United States,” says Matthew Hartwig, MD, MHS, a lung transplant surgeon at Duke Medical Center and co-Director of the Duke Ex-Vivo Organ Perfusion Laboratory.
“We are thrilled to strengthen our partnership with the Lung Transplant Foundation and are highly encouraged that such a preeminent group as the LTF is working with us to accelerate our commercialization program for multiple products that will address improved lung preservation,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “Based on our positive clinical results reported for the Paragonix SherpaPak™ Cardiac Transport System, we believe the extension of our product line to lung transplantation will be an important contribution in this field and ensure the best possible practices for the preservation of the precious gift of life.”
References
1 Callahan and Uccellini. OPTN/UNOS Mini-Brief Broader Sharing of Adult Donor Lungs, Nov 2017.
2 https://medicine.wustl.edu/news/new-rules-for-lung-transplants-lead-to-unintended-consequences/?utm_source=linkedin&utm_medium=organic_social&utm_campaign=research&utm_content=new_rules_for_lung_transplants_lead_unintended_consequences&hootPostID=fba2caf8e15deca220b1c67b21280c2f
3 J Thorac Dis. 2010 Jun; 2(2): 111–116.
4 Orphanet J Rare Dis. 2008; 3: 8.
5 https://www.who.int/respiratory/copd/burden/en/
6 https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/
7 https://www.transplants.org/faq/how-much-does-transplant-cost
8 Milliman Research Report, “2014 US Organ and Tissue Transplant Cost Estimates and Discussion”