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Coronavirus / Medical Device Stock News Bites: Beyond Air (NASDAQ: $XAIR) Submits Investigational Device Exemption (IDE) to the United States Food and Drug Administration (FDA) for the Treatment of COVID-19 Patients


GARDEN CITY, N.Y. and REHOVOT, Israel - March 16, 2020 ( Newswire) Coronavirus / Medical Device Stock News Bites - 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 for the treatment of solid tumors, today announced submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) for use of its LungFit™ BRO system in the treatment of COVID-19 patients. Typically, the FDA responds within 30 days of an IDE submission.

"There is a mounting body of evidence that inhaled NO, including NO generated and delivered by our LungFit™TM BRO system, is safe and well-tolerated in animals and in human subjects at concentrations of 150 ppm and higher. In vitro evidence1 points to inhibition of viral replication in a variety of viruses, including coronaviruses, as well as anti-inflammatory properties of nitric oxide," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We believe that our LungFit™TM BRO system may, given the three completed pilot clinical studies in bronchiolitis, be a significant tool in the battle against this coronavirus that has reached global pandemic status. In response to the unprecedented nature of the COVID-19 situation, Beyond Air is taking all necessary steps to make this potential solution available as quickly as possible to ensure that clinicians have access to NO therapy as a treatment option."

"Nitric oxide therapy at high concentrations is an innovative and potentially ground breaking treatment option against COVID-19. The LungFit™TM BRO system is a practical and effective mode of delivery of nitric oxide for both patients and medical teams," added Andrew Colin, M.D., Batchelor Family Professor of Cystic Fibrosis and Pediatric Pulmonology Director, Division of Pediatric Pulmonology Miller School of Medicine University of Miami. "Combatting this pandemic is of crucial importance and having the LungFit™TMBRO system tested and available as expeditiously as possible should be a priority for all parties."

COVID-19 trial design highlights
Subject to FDA approval of our IDE, the Company plans to test the LungFit™TM BRO for use in the treatment of patients suffering from COVID-19 in an open label study of 75 patients between the ages of 22 and 75 years confirmed with COVID-19 that require hospitalization. Subjects would be randomized 2:1 and treated with 150 ppm NO administered over 40 minutes, 4 times per day, in addition to standard of care (SOC) or SOC alone. The primary endpoint is time to clinical improvement based on key parameters such as fever and oxygen support. Other endpoints include reduction in viral load, fever resolution, oxygen support, hospital length of stay, requirement of mechanical ventilation, mortality, and various biomarkers. Final trial design is subject to FDA approval of our IDE.

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