Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 123

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part II, Item 8
Chunk 123
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 the use of a high-pressure cylinder, does not require cumbersome purging procedures and places less burden on hospital staff
in carrying out safety procedures.

Our
novel LungFit® platform can also deliver a high concentration (>150 ppm) of NO directly to the lungs, which
we believe has the potential to eliminate microbial infections including bacteria, fungi and viruses, among others. We believe that current
FDA-approved NO vasodilation treatments would have limited success in treating microbial infections given the low concentrations of NO
being delivered (<100 ppm). Given that NO is produced naturally by the body as an innate immunity mechanism, at a concentration of
200 ppm, supplemental high dose NO should aid in the body’s fight against infection. Based on our preclinical studies and clinical
trials, we believe that 150 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. LungFit® PH is
the inaugural device from the LungFit® platform of NO generators that use patented ionizer technology and is the first
FDA-approved product for Beyond Air.

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We
submitted a PMA supplement to the FDA in November 2023 for the expansion of the label to include certain cardiac surgeries and on December
2, 2024 we received the CE mark under the Medical Device Regulation (“MDR”) in the EU. According to the most recent year-end
report from Mallinckrodt Pharmaceuticals (“Mallinckrodt”), sales of NO were $303.2 million in 2023 (down from $339.7 million
in 2022) 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 sales than in the U.S. We believe the addressable U.S. market for
L