Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 126

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part II, Item 8
Chunk 126
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 the second half of calendar 2023 in the United States and has made the decision to pause this study pending future
funding.

Bronchiolitis
(BRO)

Bronchiolitis
is the leading cause of hospital admission in children less than 1 year of age. The incidence is estimated to be 150 million new cases
a year worldwide, with 2-3% (over 3 million) of them severe enough to require hospitalization. Worldwide, 95% of all cases occur in developing
countries. In the U.S., there are approximately 120,000 annual bronchiolitis hospitalizations and approximately 3.2 million annual child
hospitalizations globally. Currently, there is no approved treatment for bronchiolitis. The treatment for acute viral lung infections
that cause bronchiolitis in infants is largely supportive care and is based primarily on prolonged hospitalization during which the infant
receives a constant flow of oxygen to treat hypoxemia, a reduced concentration of oxygen in the blood. In addition, systemic steroids
and inhalation with bronchodilators are sometimes utilized until recovery, but we believe that these treatments do not successfully reduce
hospital LOS. We believe the U.S. market potential for bronchiolitis to be greater than $500 million and worldwide market potential to
be greater than $1.2 billion.

The
pivotal clinical trial for bronchiolitis was originally set to be performed in the winter of 2020/21 but was delayed due to the pandemic.
We have completed three successful pilot studies for bronchiolitis. A further analysis of the three previously reported pilot studies
was presented at the ATS International Conference 2021, which was held virtually from May 14, 2021 through May 19, 2021. Analysis across
the studies (n=198 infants, mean age 3.9 months) showed that 150 ppm – 160 ppm NO administered intermittently was generally safe
and well tolerated with adverse event rates similar among treatment groups with no reported treatment-related serious adverse events.
The short course of treatments with intermittent high concentration inhaled NO was effective in shortening hospital LOS and accelerating
time to fit for discharge – a composite endpoint of clinical signs and symptoms to indicate readiness to be evaluated for hospital
discharge. This treatment was also effective in accelerating time to stable oxygen saturation – measured as SpO2 ≥ 92% in room
air. Additionally, NO at a dose of 85 ppm NO