Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 199

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1A
Chunk 199
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. A PMA
submission, which is a higher standard than a 510(k) clearance, is used to demonstrate to the FDA that a new or modified device is safe
and effective. The 510(k) is used to demonstrate that a device is “substantially equivalent” to a predicate device, that is,
one that has been cleared by the FDA. We expect that any product we seek regulatory approval for, including the Hemopurifier, will require
a PMA. The FDA approval process involves, among other things, successfully completing clinical trials and filing for and obtaining a PMA.
The PMA process requires us to prove the safety and effectiveness of our products to the FDA’s satisfaction. This process, which
includes preclinical studies and clinical trials, can take many years and requires the expenditure of substantial resources and may include
post-marketing surveillance to establish the safety and efficacy of the product. Notwithstanding the effort and expense incurred, the
process may never result in the FDA granting a PMA. Data obtained from preclinical studies and clinical trials are subject to varying
interpretations that could delay, limit or prevent regulatory approval. Delays or rejections may also be encountered based upon changes
in governmental policies for medical devices during the period of product development. The FDA can delay, limit or deny approval of a
PMA application for many reasons, including:

    ·
    our inability to demonstrate safety or effectiveness of the Hemopurifier, or any other product we develop, to the FDA’s satisfaction;

    ·
    insufficient data from our preclinical studies and clinical trials, including for our Hemopurifier, to support approval;

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    ·
    failure of the facilities of our third-party manufacturer or suppliers to meet applicable requirements;

    ·
    inadequate compliance with preclinical, clinical or other regulations;

    ·
    our failure to meet the FDA’s statistical requirements for approval; and

    ·
    changes in the FDA’s approval policies, or the adoption of new regulations that require additional data or additional clinical trials.

Modifications to products
that are approved through a PMA application generally need FDA approval. Similarly, some modifications made to products cleared through
a 510(k) may require a new 510(k). The FDA’s 510(k) clearance process usually takes from three to 12 months, but may last longer.
The process of obtaining a PMA is much costlier and more uncertain than the 510(k) clearance process and generally takes