Beyond Air, Inc. (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 LungFitTM 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 LungFitTM 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 LungFitTM 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 LungFitTM 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 LungFitTM BRO system tested and available as expeditiously as possible should be a priority for all parties.”
“There is a mounting body of evidence that inhaled NO, including NO generated and delivered by our LungFitTM 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 LungFitTM 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 LungFitTM 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 LungFitTM BRO system tested and available as expeditiously as possible should be a priority for all parties.”
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The information and publications are not meant to be, and do not constitute, financial, investment, trading, or other types of advice or recommendations supplied or endorsed by TradingView. Read more in the Terms of Use.