Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 570

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 570
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46

The certification or regulatory approval processes
of the FDA and comparable foreign regulatory authorities and notified bodies are lengthy, time-consuming and inherently unpredictable.
If we are ultimately unable to obtain certification or regulatory approval for our product candidates, our business will be substantially
harmed.

The time required to obtain certification
or regulatory approval by the FDA or notified bodies in the EU is unpredictable, typically takes many years following the commencement
of clinical trials and depends upon numerous factors. In addition, certification or regulatory approval policies, regulations or the type
and amount of clinical data necessary to gain certification or regulatory approval may change during the course of a product candidate’s
clinical development and may vary among jurisdictions, which may cause delays in the certification or regulatory approval or the decision
not to certify or approve an application. We have not obtained certification or regulatory approval for any product other than LungFit®
PH, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will
ever obtain certification or regulatory approval.

The process required by the FDA
before a new medical device may be marketed in the U.S. generally involves the following:

    ●
    completion of or reference to extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice (“GLP”);

    ●
    performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the medical device candidate for each proposed indication; and

    ●
    submission to the FDA of a 510(k), de novo application, or PMA, after completion of all pivotal clinical trials.

Applications for our product candidates could
fail to receive regulatory approval for many reasons, including but not limited to the following:

    ●
    the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

    ●
    we may be unable to demonstrate to the FDA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;

    ●
    the FDA may determine that the population studied in the clinical program was not sufficiently broad or representative to assure safety in the full population for which we seek approval;

    ●
    the FDA may disagree with our interpretation of data from preclinical studies or clinical trials;

    ●
    the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a PMA in the U.S. or elsewhere;

    ●
    the FDA or comparable