Post by Traferox Technologies Inc.

We are proud to announce that the TorEx Lung Perfusion System has received U.S. FDA Premarket Approval (PMA).    TorEx is a normothermic ex vivo lung perfusion (EVLP) system designed to enable functional assessment of donor lungs initially deemed unsuitable for transplantation, giving transplant teams additional information to support the safe utilization of donor lungs that might otherwise be declined.    Built on more than a decade of clinical research and the pioneering work of the Toronto Lung Transplant Program, EVLP has helped Toronto General Hospital double its lung transplant volume while maintaining outcomes comparable to standard-criteria donor lungs. TorEx brings this clinically validated approach to transplant centers across the United States.    To date, Traferox and its collaborating centers have completed more than 400 TorEx procedures, with approximately 67% of evaluated marginal donor lungs accepted for transplantation.    This approval represents an important step forward for transplant programs and, most importantly, for the thousands of patients waiting for a life-saving lung transplant.    We are grateful to the clinicians, researchers, engineers, regulatory experts, organ procurement organizations, donor families, and transplant recipients whose collaboration made this achievement possible.    We look forward to partnering with transplant programs across the United States as we begin the commercial launch of TorEx.    Read the full announcement: https://lnkd.in/egVrEEXC