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Beyond Air® Reports Financial Results for the First Quarter of Fiscal Year 2023
Initiated U.S. commercial launch of LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure, which received FDA approval
About this update from Beyond Air, Inc.
[{"type":"text","content":"Initiated U.S. commercial launch of LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure, which received FDA approval on June 28, 2022 Will present data from the pilot study of at-home LungFit® GO for nontuberculous mycobacterial lung infection at the American College of Chest Physicians (CHEST) in October 2022 Anticipate dosing the first patient in the Phase I trial of ultra-high concentration gaseous NO (UNO) being conducted by Beyond Cancer™, the Company’s oncology affiliate, during the current quarter Conference call scheduled for 4:30 p.m. ET today, August 11th GARDEN CITY, N.Y., Aug. 11, 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, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced financial results for its first fiscal quarter ended June 30, 2022. “Our sales team has quickly ramped up the initial phase of the commercial launch for the LungFit® PH, which received FDA approval in late-June. This initial activity includes conducting product demonstrations at numerous U.S. hospitals, which we are pleased to report have generated positive feedback from the participating hospital staff. We are also highly encouraged by the feedback received during the medical conferences our team has attended since approval. The early success of this program and initial feedback received is expected to put us on schedule to equip the first small group of hospitals with LungFit® PH systems over the next several months. We look forward to the upcoming American Association for Respiratory Care (AARC) in November and encourage investors to come see us in New Orleans,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We continue to expect to receive CE Mark for LungFit® PH in Europe during the second half of calendar year 2022. In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit® PH system to the U.S. FDA.” Recent Highlights and Upcoming Milestones LungFit® PH Received U.S. FDA approval on June 28, 2022 to treat term and near...