Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 562

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 562
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 would adversely affect our
business, operating results and prospects.

Our products may cause or contribute to adverse
medical events or be subject to failures or malfunctions that we are required to report to the FDA or comparable foreign regulatory authorities,
and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of
operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction
of the FDA or comparable foreign regulatory authorities, could have a negative impact on us.

As a commercial-stage company,
we are subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to
the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed
to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death
or serious injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the
nature of the event. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to
recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it
is an adverse event that is unexpected or removed in time from the use of the product. If we fail to comply with our reporting obligations,
the FDA could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil
monetary penalties, revocation of our device clearance or approval, seizure of our products or delay in clearance or approval of future
products.

The FDA and comparable foreign
regulatory authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects
in design or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to
require a recall must be based on a finding that there is reasonable probability that the device could cause serious injury or death.
We may also choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by us
could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design
deficiencies, packaging defects or other deficiencies or failures to comply with