Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 54

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 1
Chunk 54
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 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
LungFit® PH to be approximately $350 million and worldwide to be approximately $700 million. We initiated the first phase
of our commercial launch (the limited launch phase to introduce Lungfit PH and Beyond Air to hospitals) in July 2022, and entered into
phase 2 (to target initial market share gains in certain geographies) with an expanded commercial presence during the spring of 2023
in the U.S. and will continue to work towards a launch in the EU and globally in 2025 and beyond. We anticipate entering the
final phase of our launch process in calendar 2025 where we intend to equip our commercial organization to become the market leader in
the U.S. in a few years.

LungFit®
PRO for the treatment of viral lung infections in hospitalized patients

Viral
Community-Acquired Pneumonia (including COVID-19)

Viral
pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (“RSV”) and influenza virus. However,
newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing
to the overall burden of adult viral pneumonia. COVID-19 is an infectious disease caused by SARS-CoV-2, that resulted in a global pandemic,
causing millions of hospitalizations and over 7 million deaths worldwide reported as of January 2024, according to the World Health Organization.
Excluding the pandemic, there are approximately 350,000 annual viral pneumonia hospitalizations in the U.S., and up to 16 million annual
viral pneumonia hospitalizations globally. For the broader annual viral pneumonia hospitalizations, we believe U.S. market potential
to be greater than $1.5 billion and worldwide market potential to be greater than $3 billion.

We
initiated a pilot clinical trial in late 2020 using our novel LungFit® PRO system at 150 ppm to treat patients with VCAP. The trial
was a multi-center, open-label, randomized clinical