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FDA approvedFDA approved. Stage 4 of 4 (Authorized)

FDA Approves Traferox's TorEx System for Reassessing Donor Lungs Outside the Body

The premarket approval covers normothermic perfusion of donor lungs first judged unsuitable, with two post-approval studies required.

By News DeskJuly 22, 20262 min read
Medical illustration showing a diseased right lung being removed and a donor lung stitched to the airway and blood vessels
An NIH illustration of a lung transplant. Not related to the TorEx system described in this article. National Heart, Lung, and Blood Institute (NIH), Public domain, via Wikimedia Commons · Public domain (work of the National Heart, Lung, and Blood Institute)
FDA approvedPMA, high-risk device · P250025FDA approved. Stage 4 of 4 (Authorized)

The FDA approved this high-risk device through premarket approval (PMA), after reviewing clinical evidence of safety and effectiveness.

Key points

  • The FDA approved PMA P250025 for the TorEx Lung Perfusion System on July 15, 2026; Traferox announced it on July 22.
  • The system perfuses donor lungs initially deemed unsuitable for up to six hours so their function can be reassessed; the transplanting surgeon makes the final call.
  • The FDA requires a five-year follow-up of the 221-patient premarket study group and a new multi-center US post-approval study.

The US Food and Drug Administration has approved Traferox Technologies' TorEx Lung Perfusion System, a platform that keeps donor lungs perfused outside the body so transplant teams can reassess lungs first judged unsuitable for transplant, the Mississauga, Ontario, company announced on July 22 in a release distributed by GlobeNewswire, read via BioSpace.

The FDA's approval letter for premarket approval application P250025 is dated July 15, 2026. The application was filed on July 7, 2025, and amended on April 14, 2026, and the device carries product code PHO.

What the FDA approved

According to the letter, the system is indicated for continuous normothermic machine perfusion of donor lungs "initially deemed unsuitable for transplantation," during which time the function of the lungs outside the body can be reassessed for transplantation in adults. It consists of a mobile cart with embedded software and a single-use sterile organ chamber and cannulae set, and is used with TorEx Lung Perfusate solution for up to six hours of perfusion. The letter states that the final decision on whether the lungs are suitable for transplant remains with the transplanting surgeon.

The FDA set two post-approval studies as conditions of approval. The first continues follow-up for up to five years of everyone in the premarket TorEx Study: 221 people who received TorEx-evaluated lungs at Toronto General Hospital between December 6, 2022, and November 7, 2025, and 379 people at the same site who received lungs preserved by conventional cold storage over the same period. Its primary endpoint is survival one year after transplant. The second is a prospective, multi-center study of recipients of TorEx-evaluated lungs at all US transplant centers that receive the device, with an external comparison group drawn from national transplant network data.

What the company says

Traferox, a 2021 spin-out of University Health Network's Toronto General Hospital, said that it and collaborating transplant centers have completed more than 400 TorEx procedures, with about 67% of evaluated marginal donor lungs accepted for transplantation. Those figures are company-reported.

"Historically, approximately 80% of donor lungs in the U.S. have been discarded because their suitability for transplantation could not be determined with confidence," said Shaf Keshavjee, chief of innovation at University Health Network and Traferox's co-founder and chief medical officer. The release discloses that Keshavjee and co-founder Marcelo Cypel hold roles at both the hospital network and the company.

TorEx is the company's second product in the US market. Traferox received FDA 510(k) clearance in May 2025 for its X°Port Lung Preservation System, which keeps donor lungs at 10°C during transport, and said X°Port is now used by more than half of US lung transplant programs.

"We look forward to working with transplant programs across the United States to expand access to this important technology," said chief executive Rick Mangat. The company said it is preparing for a US commercial launch; it did not give a date or pricing.

Sources

  1. Traferox Technologies Receives FDA Premarket Approval for the TorEx Lung Perfusion System (GlobeNewswire, read via BioSpace), Traferox Technologies, July 22, 2026
  2. PMA P250025 approval letter: TorEx Lung Perfusion System, US Food and Drug Administration, July 15, 2026