Why Beyond Air Shares Are Trading Higher Premarket Today - Beyond Air (NASDAQ:XAIR)

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