Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 493

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 493
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 ppm is the
minimum therapeutic dose to achieve the desired pulmonary antimicrobial effect of NO. To date, neither the FDA nor comparable foreign
regulatory agencies in other countries or regions have approved any NO formulation and/or delivery system for >80 ppm NO.

LungFit® PH for the treatment of
Persistent Pulmonary Hypertension of the Newborn (PPHN)

In June 2022, the FDA approved
LungFit® PH to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34
weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
in conjunction with ventilatory support and other appropriate agents.

On November 26, 2024, the company received European
CE mark approval of the LungFit PH® system for the following:

    ●
    The treatment of infants >34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; and 
  
    ●
    The treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function

LungFit® PH is
the inaugural device from the LungFit® platform of NO generators that use patented ionizer technology and is the first
FDA-approved and CE Marked product for Beyond Air.

We submitted a
PMA supplement to the FDA in November 2023 for the expansion of the label to include certain cardiac surgeries. According to the
most recent year-end report from Mallinckrodt Pharmaceuticals (“Mallinckrodt”), sales of NO were $261.4 million in 2024
(down from $303.2 million in 2023) for the United States, Canada, Japan, Mexico and Australia, with ~90% in the United States.
Outside of the U.S. there are multiple market participants which translates to considerably lower relative sales than in the U.S. We
believe the U.S. sales potential of LungFit® PH to be approximately $350 million and worldwide sales potential to be
approximately $700 million or greater. We initiated the first phase of our commercial launch in July 2022 (the limited launch phase
to introduce Lungfit® PH and Beyond