Business
Beyond Air® Reports Financial Results for Second Quarter of Fiscal Year 2021 and Provides Business Update
Submitted a premarket approval (PMA) to the FDA for LungFit™ PH to treat persistent pulmonary hypertension of the newborn (PPHN) Expect patient enrollment to
About this update from Beyond Air, Inc.
[{"type":"text","content":"Submitted a premarket approval (PMA) to the FDA for LungFit™ PH to treat persistent pulmonary hypertension of the newborn (PPHN)\n Expect patient enrollment to begin next week for the acute viral pneumonia (including SARS-CoV-2) study; Patients will be treated with 150 ppm nitric oxide with LungFit™ PRO LungFit™ GO nontuberculous mycobacteria (NTM) lung infection at-home pilot study expected to start in December 2020 Conference call scheduled for today, November 11th at 4:30 pm ET GARDEN CITY, N.Y., Nov. 11, 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 (gNO) for the treatment of solid tumors, today announced financial results for its second fiscal quarter ended September 30, 2020. “Over the past few months we have achieved several significant milestones, both regulatory and clinical, across our development pipeline. Most notably, we filed a PMA for the LungFit™ PH system for the treatment of PPHN, which will be subject to the standard 180-day FDA review. If approved, LungFit™ PH will be our first commercially available product from the LungFit™ platform technology that generates nitric oxide from ambient air. I am very proud and humbled by the resilience and execution of the Beyond Air team, as we have faced many pandemic related setbacks. We are now on a clear path towards recognizing the potential of our LungFit™ platform for the treatment of respiratory conditions with the goal of improving the lives of patients,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “As the coronavirus pandemic continues to adversely affect everyday life in the United States and around the world, the Beyond Air team has adapted. Site initiation visits are ongoing for the acute viral pneumonia study, which includes patients infected with SARS-CoV-2, and we have overcome significant logistical challenges with our at-home NTM lung infection study, which is expected to begin next month. The team also identified a new opportunity in the development pipeline for ultra-high concentration gNO to treat solid tumors. This program has generated exciting preclinical data demonstrating...