Mallinckrodt announces results from gNO with EVLP study
Mallinckrodt announced top-line results from its company-sponsored, proof-of-concept study of nitric oxide gas, or gNO, with ex-vivo lung perfusion compared to lung perfusion alone in human lung transplants. The study's primary objectives were to assess the effect of nitric oxide in perfused ex-vivo lungs using an experimental, proprietary grading system to evaluate improvements in lung function including oxygenation and transplantability, as well as the total ex-vivo perfusion time of the lungs through periodic assessments during ex-vivo lung perfusion, or EVLP, as compared to standard of care alone. Top-line results from the randomized and blinded portion of this proof of concept study showed improvement in lung function and oxygenation of lungs perfused with gNO, and a higher percentage of lungs were able to be preserved for a longer period in EVLP. The EVLP time period prior to lung transplantation in this study is longer than the current standard of four to six hours.