Business
Beyond Air® Reports Financial Results for Third Quarter of Fiscal Year 2021 and Provides Business Update
U.S. FDA reviewing premarket approval (PMA) submission for LungFitTM PH to treat persistent pulmonary hypertension of the newborn (PPHN), as Company prepares
About this update from Beyond Air, Inc.
[{"type":"text","content":"U.S. FDA reviewing premarket approval (PMA) submission for LungFitTM PH to treat persistent pulmonary hypertension of the newborn (PPHN), as Company prepares for commercialization Interim results from the acute viral pneumonia (including SARS-CoV-2) pilot study using 150 ppm nitric oxide (NO) with LungFitTM PRO expected in Spring 2021 Interim results expected mid-calendar year 2021 for Nontuberculous Mycobacteria (NTM) lung infection at-home pilot study where NO is self-administered at concentrations up to 250 ppm nitric oxide with LungFitTM GO Conference call scheduled for today, February 9th, at 4:30 p.m. ET GARDEN CITY, N.Y., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric 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 third fiscal quarter ended December 31, 2020. “Over the past several months, Beyond Air has made significant clinical and regulatory progress across several indications, led by the filing of our PMA for LungFitTM PH to treat PPHN. This PMA is currently undergoing the 180-day review process at FDA, and if approved, LungFitTM PH will be the first and only commercially available product able to generate NO from ambient air. Commercial preparations are underway for a launch this summer,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “The Beyond Air team has continued to deliver on the R&D front throughout 2020 and into 2021, with interim data expected from two additional pilot trials over the next six months: the acute viral pneumonia (including COVID-19) study using LungFitTM PRO, and the at-home NTM study with LungFitTM GO. Success in these indications will further validate the safety and efficacy of the broader LungFitTM platform technology and allow us to move to high concentration NO in hospitals as well as the large, untapped home market where we can help patients with other severe lung infections with various underlying conditions such as COPD. We also continue to make progress in our solid tumor program using ultra-high concentration gNO, with the goal of starting human studies by the end of 2021....