Business
Beyond Air® Reports Financial Results for First Quarter of Fiscal Year 2021 and Provides Business Update
U.S. COVID-19 study showing positive safety profile for patients enrolled to date PMA for LungFitTM PH to treat persistent pulmonary hypertension of the
About this update from Beyond Air, Inc.
[{"type":"text","content":"U.S. COVID-19 study showing positive safety profile for patients enrolled to date\n PMA for LungFitTM PH to treat persistent pulmonary hypertension of the newborn (PPHN) expected to be submitted to the FDA at the end of September 2020 LungFitTM HOME nontuberculous mycobacteria (NTM) lung infection pilot study expected to start by the end of calendar 2020 Commercial supply agreement executed for LungFitTM and LungFitTM PH Conference call scheduled for today, Thursday, August 6th at 8:30 am ET GARDEN CITY, N.Y., Aug. 06, 2020 (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 for the treatment of solid tumors, today announced financial results for its fiscal first quarter ended June 30, 2020. “Throughout the quarter ended June 30th, the entire Beyond Air team continued to show their exceptional capabilities as we initiated our U.S. COVID-19 study, released positive data in bronchiolitis showing vastly improved benefit with the 150 ppm nitric oxide compared to the 85 ppm nitric oxide and control arms and revealed our potentially ground-breaking data in solid tumors. This positive momentum is set to continue over the next few quarters with a planned submission of the PMA for the LungFitTM PH to treat persistent pulmonary hypertension of the newborn (PPHN), continued enrollment in the U.S. study of the LungFit in COVID-19 patients, initiation of our AT-Home NTM study using the LungFitTM HOME system and progress in our solid tumor program,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We believe that nitric oxide can be an effective treatment for mild-to-moderate COVID-19 patients, and the LungFitTM is by far the optimal system to deliver the 150 parts per million concentration needed in order for nitric oxide to be effective against SARS-CoV-2. Given the progress we are making, we anticipate the opportunity this fall to evaluate the efficacy of nitric oxide delivered by LungFitTM to COVID-19 patients,” concluded Mr. Lisi. Fiscal First Quarter and Recent Highlights Initiated U.S. clinical study using the LungFit™ system to treat COVID-19 patients with NO therapy.Comp...