FDA approved Traferox Technologies' TorEx Lung Perfusion System on July 15. The PMA, P250025, covers continuous normothermic machine perfusion of adult donor lungs initially deemed unsuitable. Their function can be reassessed for up to six hours before transplant. The treating surgeon makes the final call. FDA received the application on July 7, 2025, a 373-day review; Traferox announced the decision on July 22.
TorEx is a combination product: a mobile cart with embedded software, a single-use sterile organ chamber and cannula set, and TorEx Lung Perfusate. Traferox and its partner transplant centers have run more than 400 TorEx procedures, and about 67% of the marginal lungs evaluated were accepted for transplant. The company says roughly 80% of U.S. donor lungs have historically gone unused because their suitability was uncertain.
Traferox was founded in 2021 as a spinout of University Health Network's Toronto General Hospital. Transplant surgeons Shaf Keshavjee and Marcelo Cypel are co-founders, and the Federal Economic Development Agency for Southern Ontario has funded it. Its X°Port cold preservation system, cleared under a 510(k) in May 2025, is already used by seven of the ten highest-volume U.S. lung transplant centers. FDA approved another normothermic lung system, Lung Bioengineering's LungFX, under P240033 on June 22. Selling the cold-storage box first gave Traferox a footprint in transplant programs before the PMA arrived. The perfusion launch starts with customers it already has.