Beyond Air Scores First FDA Approval For LungFit PH In Respiratory Failure

  • The FDA has approved Beyond Air Inc's XAIR 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). 
  • LungFit PH is the initial device from the LungFit therapeutic platform of nitric oxide generators. It is the first FDA-approved product for Beyond Air.
  • LungFit PH uses the Ionizer technology to generate unlimited on-demand nitric oxide from ambient air and deliver it to a ventilator circuit, regardless of dose or flow. 
  • Related: Beyond Air Presents Encouraging Update From At-Home LungFit GO Pilot Study In Lung Disease.
  • The device uses a compressor to drive room air through a plasma chamber where electrical discharge pulses are created between two electrodes. 
  • For the treatment of PPHN, the novel LungFit PH system is designed to deliver a dosage of nitric oxide (NO) to the lungs that are consistent with the current standard of care for the delivery of 20 ppm NO with a range of 0.5 ppm – 80 ppm (low concentration NO) for ventilated patients. 
  • Each Smart Filter will last 12 hours regardless of ventilator demands.
  • The Beyond Air commercial team will be actively working with select hospitals beginning this month to make LungFit PH available to them, with a broader U.S. hospital launch expected in 1H of 2023. 
  • The company ended the March quarter with cash and cash equivalents of $80.2 million.
  • Price Action: XAIR shares were up 17.3% at $6.80 during the premarket session on the last check Wednesday.
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