Paragonix Technologies and the Lung Transplant Foundation (LTF) are expanding their collaboration to drive the development of several technologies aiming to improve donor lung preservation for transplant.
These technologies include the Paragonix SherpaLung Preservation System, a special device designed to ensure lung preservation and viability during transport from donor to recipient.
Paragonix is wrapping up the commercial development of SherpaLung and is expecting regulatory clearances from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) by the end of 2019 to market the device in the U.S. and European Union.
“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,” Bill Edelman, chairman and CEO of Paragonix Technologies, said in a press release.
“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,” Edelman said.
During the International Society for Heart and Lung Transplantation (ISHLT) 2019 Annual Meeting, in Orlando, Florida, earlier this month, the LTF reviewed how the latest updates to the 2017 OPTN/UNOS policies affected the process of lung donation.
According to current policies, donor lungs may travel up to 250 miles from the donor’s hospital to be offered to first priority recipients; this distance can be increased to 575 miles, or even include the whole nation, if no matching recipients can be found.
These expanded policies have been implemented as an answer to the increasing demand for donor lungs for transplant, which has become a gold standard therapy for many patients facing respiratory failure due to idiopathic pulmonary fibrosis (IPF) or chronic obstructive pulmonary disease (COPD).
Since updated policies now enable lungs to travel much farther than before, this also means they must be stored and remain viable for longer periods of time. That’s why there is a need for solid lung preservation technologies.
“There is no more urgent time than now to provide those patients on the lung transplant waitlist with any possible advantage they can get,” said Jeff Goldstein, CEO and founding member of the LTF.
“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. And we applaud Paragonix for developing these types of technologies that will also work in a cost-conscious healthcare environment,” Goldstein said.