Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 29

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 29
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, or GNA, used in the manufacture of our Hemopurifier. We have not received
the required FDA approval of our IDE supplement for a new qualified supplier of the GNA and are working with the FDA to gain approval
of this supplier. Although we have resumed purchasing GNA from our prior supplier, it is possible that we could experience future disruptions
from this supplier as we work to qualify a second supplier. FDA review of the new second supplier could take several additional months
to obtain.

In addition, an uncorrected
impurity, a supplier’s variation in a raw material or testing, either unknown to us or incompatible with its manufacturing process,
or any other problem with our materials, testing or components, could prevent or delay the release of our Hemopurifiers for use in our
clinical trials. For example, in late 2020, we identified during our device quality review procedures prior to product release that one
of our critical suppliers had produced a Hemopurifier component that was not produced to our specifications, although no affected Hemopurifiers
were released into our inventory or to any clinical trial sites. Any such future supplier issues could have a material adverse impact
on our business, results of operations and financial condition.

 17 

Difficulties in manufacturing our Hemopurifier
could have an adverse effect upon our expenses, our product revenues and our ability to complete our clinical trials.

We received approval from
the FDA for our IDE supplement to manufacture Hemopurifiers at our site in San Diego. The manufacturing of our Hemopurifier is difficult
and complex. To support our current clinical trial needs, we comply with and intend to continue to comply with current Food Manufacturing
Practices, or cGMP in the manufacture of our product. Our ability to adequately manufacture and supply our Hemopurifier in a timely matter
is dependent on the uninterrupted and efficient operation of our facilities and those of third parties producing raw materials and supplies
upon which we rely in our manufacturing. The manufacture of our products may also be impacted by:

    ·
    availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier;

    ·
    our ability to comply with new regulatory requirements, including our ability to comply with cGMP;

    ·
    natural disasters;

    ·
    changes in forecasts of future demand for product components;

    ·
    potential facility contamination by microorganisms or viruses;

    ·