Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 571

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 571
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 foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

    ●
    the approval policies or regulations of the FDA or comparable foreign regulatory authorities and notified bodies may significantly change in a manner rendering our clinical data insufficient for certification or approval; and

This lengthy certification or
regulatory approval process, as well as the unpredictability of the results of clinical trials, may result in our failing to obtain certification
or regulatory approval to market any of our product candidates, which would significantly harm our business, results of operations and
prospects.

47

Our business and sale of our approved product
and product candidates are subject to extensive regulatory requirements, including compliance with labelling, manufacturing and reporting
controls. If we fail or are unable to timely obtain the necessary 510(k) clearances, de-novo authorizations, or PMA approvals for new
products, or equivalent steps in third countries including the EEA, our ability to generate revenue could be materially harmed.

Our approved product and product
candidates are classified as medical devices and are subject to extensive regulation in the United States by the FDA and other federal,
state and local authorities and by comparable foreign regulatory authorities. The FDA can delay, limit or deny 510(k) clearance, authorization
of a de novo application, or PMA approval of a device for many reasons, including:

    ●
    we may not be able to demonstrate to the FDA’s satisfaction that our systems are safe and effective for its intended use;

    ●
    the data from our preclinical studies and clinical trials may be insufficient to support clearance or approval, where required;

    ●
    the manufacturing process or facilities we use or contract to use may not meet applicable requirements; and

    ●
    disruptions at the FDA caused by funding shortages or global health concerns, including the COVID-19 pandemic.

The FDA may refuse our requests
for 510(k) clearance, de-novo or PMA of new products, new intended uses or modifications to existing products.

From time to time, legislation
is drafted and introduced in the United States that could significantly change the statutory provisions governing any regulatory approval
or clearance that we receive in the United States. In addition, the FDA may change its clearance and approval policies, adopt additional
regulations or revise existing regulations, or take other actions which may prevent or delay approval or clearance of our test kits under
development or impact our ability to modify our currently approved