MISSISSAUGA, Ontario, July 22, 2026 (GLOBE NEWSWIRE) — Traferox Technologies, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the 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 prior to transplantation.
The TorEx Lung Perfusion System is indicated for use in continuous normothermic machine perfusion of donor lungs, initially deemed unsuitable for transplantation, during which time the ex vivo function of the lungs can be reassessed for transplantation in adults.
“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, Chief Executive Officer of Traferox Technologies. “This approval reflects years of collaboration among leading transplant clinicians, scientists, engineers, regulatory experts, and our industry partners. We are grateful to the clinicians, donor families, and patients who contributed to the clinical development of TorEx. We look forward to working with transplant programs across the United States to expand access to this important technology.”
“TorEx is the second product Traferox has introduced to the U.S. transplant market,” said Joe Kletzel, President of Traferox Technologies. “The rapid adoption of our 10°C X°Port Lung Preservation System has demonstrated that transplant programs value technologies that are intuitive to use, supported by robust clinical evidence, and which offer a sustainable value proposition for both patients and healthcare systems. Today, X°Port has been adopted by seven of the ten highest-volume lung transplant centers and by more than half of all U.S. lung transplant programs. We believe TorEx addresses another significant unmet clinical need and represents an important next step in expanding access to lung transplantation.”
Since the introduction of EVLP at Toronto General Hospital, part of University Health Network, the lung transplant program has doubled its transplant volume while maintaining clinical outcomes comparable to those achieved with standard-criteria donor lungs. Earlier transplantation also reduces time spent on the waiting list, allowing patients to undergo transplantation before further clinical deterioration. Health economic analyses estimate that implementation of EVLP has reduced healthcare costs in Ontario by more than $20 million annually, primarily through shorter waitlist times and reduced and postoperative costs1.
To date, Traferox and its collaborating transplant centers have completed more than 400 TorEx procedures, with approximately 67% of evaluated marginal donor lungs accepted for transplantation. The company is preparing for the commercial launch of the TorEx Lung Perfusion System across the United States.
“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 Dr. Shaf Keshavjee, Chief of Innovation at University Health Network and Co-founder and Chief Medical Officer of Traferox Technologies. “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.”
“TorEx builds on more than a decade of clinical research in ex vivo lung perfusion,” said Dr. Marcelo Cypel, Director of the Toronto Lung Transplant Program and Co-founder and Chief Scientific Officer of Traferox Technologies. “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.”
In May 2025, Traferox received FDA 510(k) clearance for its X°Port® Lung Preservation System, a device designed to preserve donor lungs at 10°C during transportation. A growing body of published clinical evidence supports the use of 10°C preservation together with EVLP to extend preservation time, increase utilization of donor lungs, and expand access to lung transplantation.
Traferox appreciates the dedication and professionalism of the FDA review team throughout the PMA review process and thanks its clinical collaborators, organ procurement organizations, donor families, and transplant recipients whose partnership made this milestone possible.
About the TorEx® Lung Perfusion System
The TorEx Lung Perfusion System is a normothermic ex vivo lung perfusion platform that enables transplant teams to assess donor lung function outside the body under physiologic conditions prior to transplantation. By providing clinically relevant functional information, TorEx supports informed decision-making regarding donor lung suitability and has the potential to increase utilization of donor lungs that might otherwise be declined.
About TorEx Lung Perfusate
TorEx Lung Perfusate is an acellular perfusion solution indicated for use in Ex Vivo Lung Perfusion (EVLP). It enables the safe perfusion and functional assessment of isolated donor lungs following removal from the donor, in preparation for eventual transplantation. By supporting this evaluation, the perfusate can help increase the number of donor lungs available for transplant.
IMPORTANT SAFETY INFORMATION
Indications for Use
The TorEx Lung Perfusion System is indicated for use in continuous normothermic machine perfusion of donor lungs, initially deemed unsuitable for transplantation, during which time the ex vivo function of the lungs can be reassessed for transplantation in adults. The TorEx Lung Perfusion System includes a mobile cart with embedded software, single-use sterile Organ Chamber and Cannulae set and is used with TorEx Lung Perfusate solution to perform ex vivo lung perfusion for up to 6 hours.
Note: The TorEx System is used to evaluate the quality of donated lungs, but the final determination of the suitability of the lungs for transplant remains with the transplanting surgeon.
Contraindications
There are no known contraindications.
Please refer to the Instructions for Use for complete indications, warnings, precautions, and operating instructions.
About Traferox Technologies
Traferox Technologies, Inc. is a medical device company headquartered in Mississauga, Ontario, Canada, dedicated to advancing organ transplantation through innovative preservation and organ assessment technologies. Founded in 2021 as a spin-out of University Health Network’s Toronto General Hospital, Traferox develops and commercializes technologies that expand access to transplantation through scientifically validated, clinically practical solutions that are easy to adopt and deliver sustainable value for healthcare systems worldwide.
The company’s growing portfolio includes technologies for donor lung and heart preservation and assessment, with a mission to improve transplant outcomes and increase access to life-saving organs for patients around the world.
Disclosures
Dr. Shaf Keshavjee is Chief of Innovation at University Health Network (UHN) in Toronto, Canada, and co-founder and Chief Medical Officer of Traferox Technologies. Marcelo Cypel is Director of the Toronto Lung Transplant Program at University Health Network (UHN) in Toronto, Canada, and co-founder and Chief Scientific Officer of Traferox Technologies. Traferox was founded to develop and commercialize organ preservation and assessment technologies originating from research conducted at UHN and the University of Toronto, including innovations in ex vivo lung perfusion and donor organ preservation.
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Traferox Technologies, Inc.
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Website: www.traferox.com
1 Peel, J. K., et al. (2023). Determining the impact of ex-vivo lung perfusion on hospital costs for lung transplantation: A retrospective cohort study. The Journal of Heart and Lung Transplantation, 42(3), 356–367.
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