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Beyond Air’s LungFit® PH Receives FDA Approval to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure
First and only nitric oxide generator and delivery system indicated for the treatment of term and near-term neonates with hypoxic respiratory failure that
About this update from Beyond Air, Inc.
[{"type":"text","content":"First and only nitric oxide generator and delivery system indicated for the treatment of term and near-term neonates with hypoxic respiratory failure that uses ambient air to provide unlimited, on-demand nitric oxide Eliminates the need for traditional nitric oxide tanks from the hospital setting and the associated burdens to providers LungFit® PH is the first FDA-approved product from Beyond Air’s LungFit® therapeutic platform of nitric oxide generators targeting pulmonary disease Beyond Air scheduled to host investor conference call today, June 28th at 4:30 PM ET 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 that the U.S. Food and Drug Administration (FDA) has approved LungFit® PH to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN) (prescription use only). LungFit PH is the initial device from the LungFit therapeutic platform of nitric oxide generators that use our patented Ionizer™ technology and is the first FDA-approved product for Beyond Air. LungFit PH is the first FDA-approved product that generates on-demand nitric oxide from ambient air for the treatment of term and near-term neonates with hypoxic respiratory failure The LungFit platform uses unique patented Ionizer™ technology to generate nitric oxide on-demand from ambient air, designed and built by the same inventors that developed the first nitric oxide delivery system and subsequent systems still in use today as the current global market leader Steve Lisi, Chairman and CEO of Beyond Air, commented, “The FDA approval of LungFit PH enables a new era of nitric oxide therapy and marks a pivotal event for Beyond Air as we officially enter the U.S. market. As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers healthcare providers to maximize the efficiency of a hospital when treating PPHN by moving beyond their reliance on traditiona...