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Traferox Technologies has received FDA Premarket Approval (PMA) for its TorEx® Lung Perfusion System, an ex vivo lung perfusion (EVLP) platform designed to assess donor lungs outside the body before transplantation.
The system enables transplant teams to evaluate the function of donor lungs initially considered unsuitable for transplantation, potentially increasing the number of organs available for patients awaiting life-saving procedures. Traferox said the technology has supported more than 400 procedures to date, with approximately 67% of evaluated marginal donor lungs accepted for transplantation.
“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. “We look forward to working with transplant programs across the United States to expand access to this important technology.”
The approval builds on Traferox’s existing lung preservation portfolio, including the X°Port® Lung Preservation System, which received FDA clearance in 2025. The company is now preparing for the commercial launch of TorEx across the U.S. as it aims to improve donor lung utilization and expand access to transplantation.
