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 (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 (up to 12 hours). The EVLP time period prior to lung transplantation in this study is longer than the current standard of four to six hours.
EVLP describes a process of evaluating, rehabilitating, and improving possible donor lungs outside the body. At normal body temperature, the lungs are perfused and 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.
About the Study
This proof-of-concept, randomized, multicenter, blinded study assessed the effects of gNO in modified criteria human lung transplants via EVLP. It was conducted at three major U.S. lung transplant centers. The study evaluated extended (modified) criteria bilateral donor lungs, not eligible for lung transplantation. The study is ongoing with a small open-label sub-study in a single center to be completed in the second quarter of 2019.
About Lung Transplantation in Humans
In the U.S. each year, over 2,200 people receive a lung transplant1 – the surgical replacement of either a single or two (double) severely diseased lungs with healthy lungs from a human organ donor. A variety of diseases and conditions can damage a person's lungs and hinder their ability to function effectively, such as chronic obstructive pulmonary disease (COPD) including emphysema; scarring of the lungs; pulmonary fibrosis; cystic fibrosis; sarcoidosis; and pulmonary hypertension.2 The major limiting factor to the number of transplants performed is donor lung shortage.3 According to Organ Procurement Transplant Network data, approximately 130.5 deaths per 100,000 persons with severe lung disease occurred in 2014, with about 1400 patients with severe lung disease on the waiting list in the U.S.4
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Cautionary Statements Related to Forward-Looking Statements
This release includes forward-looking statements concerning the study described in this release, including expectations with regard to the study, future research plans and the potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of
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1 Valapour M, Skeans MA, Smith JM, et al. OPTN/SRTR 2015 Annual Data Report: Lung.
2 Mayo Clinic Patient Care and Health Information, Lung Transplant. https://www.mayoclinic.org/tests-procedures/lung-transplant/about/pac-20384754 Accessed
3 Van Raemdonck D; Neyrinck A; Verleden GM, et al. Lung Donor Selection and Management. Annals of the
4 Organ Procurement and Transplant Network Data. https://optn.transplant.hrsa.gov/data/ Accessed
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