Business
Beyond Air® Reports Financial Results for Fourth Fiscal Quarter and Year-End 2021
Submitted first premarket approval (PMA) application in the Company’s history to FDA for LungFit® PH to treat persistent pulmonary hypertension of the newborn
About this update from Beyond Air, Inc.
[{"type":"text","content":"Submitted first premarket approval (PMA) application in the Company’s history to FDA for LungFit® PH to treat persistent pulmonary hypertension of the newborn (PPHN); Company preparing for commercial launch in the fourth quarter of calendar year 2021 Expanded the commercial and business development teams by appointing executives with extensive nitric oxide (NO) experience Presented positive data for 150 – 160 ppm NO from LungFit® PRO programs in hospitalized patients (adults and infants) with viral lung infections at CHEST 2020 and at ATS 2021 Received grant from the Cystic Fibrosis Foundation (CFF) for ongoing nontuberculous mycobacteria (NTM) at-home pilot study delivering up to 250 ppm NO via LungFit® GO Presented positive preclinical data for the solid tumor program at three scientific conferences; data suggest exogenous ultra-high concentration gaseous NO (gNO) can trigger anti-tumor immunity Conference call scheduled for today, Thursday, June 10th, at 4:30 p.m. ET GARDEN CITY, N.Y., June 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 fourth quarter and fiscal year ended March 31, 2021. “The submission of the first PMA application to the FDA in our Company’s history has placed us on a clear path for the transformative year ahead. I am confident that when approved to treat PPHN, LungFit® PH will revolutionize the market as the first and only commercially available system that is capable of generating NO from ambient air. In preparation for commercial launch, our organization has grown considerably over the past twelve months, recruiting unparalleled talent with extensive experience in the NO market. I believe our team is more than prepared to bring our first NO generator and delivery system to NICUs across the United States later this year,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Looking beyond PPHN, we have made progress in our other potential indications for the LungFit® platform, which have much larger underserved patient populations. We recently present...