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Beyond Air® Reports Financial Results for Fourth Fiscal Quarter and Year-End 2022
LungFit® PH received FDA approval for the treatment of term and near-term neonates with hypoxic respiratory failure on June 28, 2022 and the first phase of
About this update from Beyond Air, Inc.
[{"type":"text","content":"LungFit® PH received FDA approval for the treatment of term and near-term neonates with hypoxic respiratory failure on June 28, 2022 and the first phase of U.S. commercial launch has begun Presented positive data for high-concentration nitric oxide (NO) with LungFit® PRO in hospitalized patients with community-acquired viral pneumonia, including COVID-19, at ECCMID 2022 Presented positive long-term safety data for high-concentration NO at PAS 2022 in infants hospitalized with bronchiolitis Presented positive updated interim data from the ongoing at-home LungFit® GO pilot study for nontuberculous mycobacterial lung disease at ATS 2022 Patient screening has begun for the Phase I trial of ultra-high concentration gaseous NO (UNO) being conducted by the Company’s oncology affiliate, Beyond Cancer™ Conference call scheduled for 4:30 p.m. ET today, June 28th GARDEN CITY, N.Y., June 28, 2022 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced financial results for its fiscal fourth quarter and year ended March 31, 2022. “Through hard work and dedication, we have achieved the goal of FDA approval for our first LungFit® system,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We believe the introduction of this groundbreaking system, LungFit PH, will transform the way nitric oxide is used by hospital staff and provide numerous benefits related to safety and cost. In addition, we are on track to receive CE Mark for LungFit PH in Europe during the second half of calendar year 2022. Looking beyond LungFit PH, we believe receiving this initial regulatory approval in the U.S. validates our patented Ionizer™ technology and creates a path forward for the other devices in the LungFit platform, including LungFit PRO and LungFit GO, to address other respiratory indications with even larger patient populations with unmet medical needs.” Mr. Lisi added, “Over the past few months we have taken significant strides in our other clinical programs, presenting new dat...