Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 568

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 568
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 were small and conducted outside the US, so it is unlikely that the FDA will view
them as significant because of their size and scope. Therefore, we intend to conduct larger clinical trials aiming for statistically and
clinically significant favorable results, or we will not be able to obtain certification or regulatory approval to market such product
candidates. It may be some time before a pivotal trial is initiated, if at all, for such product candidates. Before a medical device clinical
trial can be undertaken in the U.S., the sponsor of the trial must submit an IDE application for a medical device and the FDA must permit
the trial to go forward. We cannot assure that we will obtain such agency acquiescence in a timely manner, or at all. In addition to our
respiratory program using the LungFit® device, we have programs in Cancer and Autism which require significant further development
before submission to the FDA.

Although
we received approval of LungFit® PH from the FDA, we can make no assurances as to what any other comparable foreign regulatory
authorities and notified bodies where we are seeking certification or regulatory approval will do. We are expending significant resources
to commercialize LungFit® PH in the U.S. and we can make no assurances that our efforts will be successful. We cannot be
certain that any of our product candidates will be successful in clinical trials or receive certification or regulatory approval. Further,
our product candidates may not receive certification or regulatory approval even if they are successful in clinical trials. If we do not
receive certification or regulatory approvals for our other product candidates, we may not be able to continue our operations.

45

We generally
plan to seek certification or regulatory approval to commercialize our approved product and product candidates in the U.S., the EU and
in additional foreign countries, as applicable. To obtain certification or regulatory approvals we must comply with the numerous and varying
regulatory requirements of such countries regarding safety, efficacy, chemistry, manufacturing and controls, clinical trials, commercial
sales, pricing and distribution of our approved product and product candidates. Even if we are successful in obtaining marketing certification
or regulatory approval in one jurisdiction, we cannot ensure that we will obtain certification or regulatory approval in any other jurisdictions.
If we are unable to obtain certification, clearance or approval for our product candidates in multiple jurisdictions, our revenue and
results of operations would be negatively affected.

Some
of our product candidates may be considered a drug/device combination and the process for obtaining regulatory approval in the U.S. on