Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 30

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 30
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    updating of manufacturing specifications;

    ·
    product quality success rates and yields; and

    ·
    global viruses and pandemics.

Any future interruption in
the manufacture and supply of our Hemopurifier could delay shipments of our Hemopurifier for use in clinical trials in the United States,
Australia and India.

Our products are
manufactured with raw materials that are sourced from specialty suppliers with limited competitors and we may therefore be unable to access
the materials we need to manufacture our products.

Specifically, the Hemopurifier
contains three critical components with limited supplier numbers. The base cartridge on which the Hemopurifier is constructed is sourced
from Medica S.p.A and we are dependent on the continued availability of these cartridges. We currently purchase the diatomaceous earth
from Janus Scientific Inc., our distributor; however, the product is manufactured by Imerys Minerals Ltd., which is the only supplier
of this product. The GNA is sourced from Vector Laboratories, Inc. and also is available from other suppliers; however, Sigma Aldrich
is our only potential back up supplier at this time and we are in the process of working with the FDA to obtain regulatory approval for
this supplier. A business interruption at any of these sources, including the interruption resulting from the delay in obtaining FDA approval
of our new GNA supplier, has and may continue to have a material impact on our ability to manufacture the Hemopurifier.

 18 

We face intense competition in the medical device industry.

We compete with numerous U.S.
and foreign companies in the medical device industry, and many of our competitors have greater financial, personnel, operational and research
and development resources than we do. We believe that because the field of exosome research is burgeoning, multiple competitors are or
will be developing competing technologies to address exosomes in cancer. Progress is constant in the treatment and prevention of viral
diseases, so the opportunities for the Hemopurifier may be reduced there as well. Diagnostic technology may be developed that can supplant
diagnostics we are developing for viruses and cancer. Our commercial opportunities will be reduced or eliminated if our competitors develop
and market products for any of the diseases we target that:

    ·
    are more effective;

    ·
    have fewer or less severe adverse side effects;

    ·
    are better tolerated;

    ·
    are more adaptable to various modes of dosing;

    ·
    are easier to administer; or

    ·