Canada-based medical device company Traferox Technologies has received US Food and Drug Administration (FDA) Premarket Approval (PMA) for its TorEx Lung Perfusion System with TorEx Lung Perfusate (TLP), an ex vivo lung perfusion (EVLP) platform designed to enable functional assessment of donor lungs outside the body before transplantation.
The TorEx Lung Perfusion System is indicated for use in continuous normothermic machine perfusion of donor lungs that were initially deemed unsuitable for transplantation, allowing clinicians to reassess lung function before transplantation in adult patients.
The system comprises a mobile cart with embedded software, a single-use sterile organ chamber and cannulae set, and TorEx Lung Perfusate, enabling ex vivo lung perfusion for up to six hours.
TorEx Lung Perfusate enables the safe perfusion and functional assessment of isolated donor lungs after retrieval from the donor and before transplantation. By supporting this evaluation, the solution can help increase the number of donor lungs available for transplant.
“FDA approval of TorEx represents an important milestone for Traferox and, more importantly, for the thousands of patients waiting for a life-saving lung transplant in the United States,” said Rick Mangat, CEO of Traferox Technologies.
Dr. Shaf Keshavjee, co-founder and chief medical officer of Traferox Technologies, said that historically, nearly 80% of donor lungs in the United States had been discarded because clinicians were unable to determine their suitability for transplantation with confidence.
“By evaluating donor lungs outside the body under physiologic conditions, clinicians can better understand organ function, allowing many donor lungs that might otherwise have been declined to be safely transplanted,” he added.
According to Dr. Marcelo Cypel, co-founder and chief scientific officer of Traferox Technologies, TorEx is the result of more than a decade of clinical research in ex vivo lung perfusion.
“Evaluating donor lungs under normothermic physiologic conditions provides transplant teams with critical functional information that cannot be obtained through conventional donor assessment alone. Combined with 10°C preservation technology, TorEx expands what is possible in donor lung preservation and transplantation,” he said.
TorEx is the second product Traferox has introduced to the US transplant market. In May 2025, the company received FDA 510(k) clearance for its X°PortLung Preservation System, a device designed to preserve donor lungs at 10°C during transportation.
Joe Kletzel, President of Traferox Technologies, said X°Port has been adopted by seven of the ten highest-volume lung transplant centers and by more than half of all US lung transplant programmes.
“We believe TorEx addresses another significant unmet clinical need and represents an important next step in expanding access to lung transplantation,” he added.
The company is now preparing for the commercial launch of the system across the United States.
