Beyond Air, Inc. (XAIR) Announces Delay in Approval Timeline for LungFit PH
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Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced an update to the expectations for U.S. Food and Drug Administration (FDA) approval of LungFit® PH for the treatment of persistent pulmonary hypertension of the newborn, or PPHN.
Based upon our ongoing communications with the FDA, the Company no longer believes that the U.S. commercial launch of LungFit® PH will take place prior to December 31, 2021. Beyond Air remains on track to receive CE Mark for LungFit® PH in Europe in the first half of calendar year 2022.
“The Beyond Air team continues to work towards our goal of bringing LungFit® PH, the groundbreaking nitric oxide generator and delivery system, to NICUs across the United States and the world as soon as possible,” commented Steve Lisi, Chairman and CEO of Beyond Air. “We commend the FDA for their continued commitment to provide us with a comprehensive review of our application. We shall continue to collaboratively work with the FDA to approve LungFit® PH.”
About Beyond Air, Inc.Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit®, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. The LungFit® can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit® for clinical trials for the treatment of severe lung infections such as acute viral pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM). Additionally, Beyond Air, through its affiliate, Beyond Cancer, is using ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.
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