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Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023
Commercial launch underway for LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure, which received FDA approval on
About this update from Beyond Air, Inc.
[{"type":"text","content":"Commercial launch underway for LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure, which received FDA approval on June 28, 2022 Presented favorable safety, tolerability, and efficacy results from the pilot study of at-home LungFit® GO for nontuberculous mycobacterial (NTM) lung infection at the American College of Chest Physicians (CHEST) Preclinical data showing prolonged survival for ultra-high concentration nitric oxide (UNO) in combination with anti-PD1 to be unveiled at the Society for Immunotherapy of Cancer (SITC) on November 10, 2022 Conference call scheduled for 4:30 p.m. ET today, November 8th GARDEN CITY, N.Y., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) a 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, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced financial results for its second fiscal quarter ended September 30, 2022. “Our commercial team continues to successfully execute the initial phase of the LungFit PH launch following FDA approval in late-June 2022. Over the past few months, the demand for product evaluations and demonstrations have exceeded expectations. We are pleased to report that participating hospital staff have provided a steady flow of positive feedback,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit® PH system to the FDA.” “During the quarter, we presented positive data that support the development programs for the LungFit system using high dose NO as a potential treatment for several indications. At the CHEST Annual Meeting 2022 we presented favorable safety, tolerability, and efficany data for our LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease, which further support development of intermittent high dose NO for the treatment of NTM as well as other chronic respiratory infections. We believe this study breaks new ground in the development of NO therapy by successfully showing the ability of our at-home ...