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Beyond Air® Reports Financial Results for the First Quarter of Fiscal Year 2022
U.S. FDA reviewing premarket approval (PMA) submission for LungFit® PH to treat persistent pulmonary hypertension of the newborn (PPHN); On track for
About this update from Beyond Air, Inc.
[{"type":"text","content":"U.S. FDA reviewing premarket approval (PMA) submission for LungFit® PH to treat persistent pulmonary hypertension of the newborn (PPHN); On track for commercial launch in the fourth quarter of calendar year 2021 Anticipate reporting interim results from the LungFit® GO Nontuberculous Mycobacteria (NTM) lung infection at-home pilot study (self-administration) in Fall 2021 Positive data presented at American Thoracic Society in May 2021 from acute viral pneumonia (including COVID-19) study using LungFit® PRO at 150 ppm NO Solid tumor program expected to receive regulatory clearance to initiate first in human studies by the end of calendar year 2021 Conference call scheduled for today, August 10th, at 4:30 p.m. ET GARDEN CITY, N.Y., Aug. 10, 2021 (GLOBE NEWSWIRE) -- 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 gaseous NO (gNO) for the treatment of solid tumors, today announced financial results for its first fiscal quarter ended June 30, 2021. “Our commercial team is ready to introduce the LungFit® PH system to hospitals across the United States, with FDA approval anticipated to be received at the end of next month. I am confident in our ability to successfully bring to market what will be the first-ever FDA approved generator and delivery system that produces NO from ambient air. LungFit® PH is designed to offer a simple, safe, cost effective and convenient alternative to the NO delivery systems that are currently available to treat PPHN,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We are making progress in our other programs and anticipate reporting interim data from our at-home NTM pilot study using LungFit® GO in the fall. Our LungFit® PRO acute viral pneumonia study in adults, which includes COVID-19 patients, remains open and we expect to discuss our progress with FDA this fall in order to plan next steps. We also expect to receive regulatory clearance to start human studies in our solid tumor program using ultra-high concentration gNO around the end of calendar year 2021 and begin enrolling patients in early 2022.” Duncan Fatkin, Chief Commercial Officer of Beyond Air, stated, “O...