Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 37

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 37
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 our products could be delayed or prevented entirely.

Our Hemopurifier product is
subject to extensive government regulations related to development, testing, manufacturing and commercialization in the United States
and other countries. The determination of when and whether a product is ready for large-scale purchase and potential use will be made
by the U.S. Government through consultation with a number of governmental agencies, including the FDA, the National Institutes of Health,
the CDC and the Department of Homeland Security. Our Hemopurifier has not received required regulatory approval from the FDA, or any foreign
regulatory agencies, to be commercially marketed and sold. The process of obtaining and complying with FDA and other governmental regulatory
approvals and regulations in the United States and in foreign countries is costly, time consuming, uncertain and subject to unanticipated
delays. Obtaining such regulatory approvals, if any, can take several years. Despite the time and expense exerted, regulatory approval
is never guaranteed. We also are subject to the following risks and obligations, among others:

    ·
    the FDA may refuse to approve an application if it believes that applicable regulatory criteria are not satisfied;

    ·
    the FDA may require additional testing for safety and effectiveness;

    ·
    the FDA may interpret data from pre-clinical testing and clinical trials in different ways than we interpret them;

    ·
    if regulatory approval of a product is granted, the approval may be limited to specific indications or limited with respect to its distribution; and

    ·
    the FDA may change its approval policies and/or adopt new regulations.

 22 

Failure to comply with these
or other regulatory requirements of the FDA may subject us to administrative or judicially imposed sanctions, including:

    ·
    warning letters;

    ·
    civil penalties;

    ·
    criminal penalties;

    ·
    injunctions;

    ·
    product seizure or detention;

    ·
    product recalls; and

    ·
    total or partial suspension of productions.

Delays in successfully commencing or completing
our planned clinical trials could jeopardize our ability to obtain regulatory approval and sustain our operations.

Our business prospects depend
on our ability to complete studies, commence and complete our planned clinical trials, including our ongoing and planned studies in solid
tumors in cancer, obtain satisfactory results, obtain required regulatory approvals and successfully commercialize our Hemopurifier product
candidate. Completion of our clinical trials, announcement of results of the trials and our ability to obtain regulatory approvals could