Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 98

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part II, Item 8
Chunk 98
---
 (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.

24

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 Air to hospitals), and entered into phase 2 (target initial market share gains in certain geographies) with an expanded
commercial presence during the spring of 2023 in the U.S. We recently entered the final phase of our launch process where we will equip
our commercial organization to become