Mallinckrodt has initiated a company-sponsored, experimental, proof-of-concept study of nitric oxide gas with ex-vivo lung perfusion compared to lung perfusion alone in human lung transplants. The study has enrolled its first set of lungs, and the actual lungs to be evaluated are being assigned for research use, not for human lung transplantation.

The study's primary objectives are to assess the effects of nitric oxide in perfused ex-vivo lungs using a proprietary grading system and to evaluate the total ex-vivo perfusion time of the lungs through periodic assessments during Ex-Vivo Lung Perfusion (EVLP).

EVLP describes a process of evaluating and preparing donor lungs outside the body; nutrients are perfused, or circulated, through the organ, and the organ is ventilated to mimic physiologic function prior to transplant surgery. EVLP has the potential to increase the available donor pool through restoring and repairing donor lungs.

"Mallinckrodt is focused on providing treatment options for the unmet needs of and to improve outcomes for patients with severe and critical conditions. The company has more than 20 years of experience with and investment in nitric oxide as a signaling molecule," said Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are pleased to begin and learn from this important research evaluating nitric oxide gas for potential use in lung transplantation as the company seeks to establish and grow its presence in this therapeutic area."

This proof-of-concept randomized, multicenter, blinded study will assess the effects of nitric oxide in modified criteria human lung transplants via EVLP. It is planned to be conducted at four major U.S. lung transplant centers through the fourth quarter of 2018. The study will evaluate extended criteria bilateral donor lungs, not suitable for lung transplantation. Upon a successful proof-of-concept study, the company expects to initiate a safety study to assess use of nitric oxide in human lung transplantation in 2019.

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