Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 494

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 494
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 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 the market leader in the U.S. in a few years. Since
receiving CE Mark in late November, 2024, we have received regulatory approvals in Australia, New Zealand, Hong Kong and Thailand
with our partner Getz Healthcare and are awaiting approvals in several other countries in South East Asia. Additionally, we have
signed new distribution agreements covering France, Italy, Turkey, India, Saudi Arabia, and Morocco,
among others. We anticipate significant contribution to revenues in fiscal 2026 and beyond from these and future partnerships.

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 6.6 million deaths worldwide as of January 2023 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 trial in Israel, including patients infected with COVID-19. Patients were randomized in a 1:1 ratio to receive either
inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive
t