Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 61

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 61
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functions, manufacturing errors, design
or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and
have an adverse effect on our reputation, results of operations and financial condition, which could impair our ability to produce our
products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be subject to liability claims,
be required to bear other costs, or take other actions that may have a negative impact on our future sales and our ability to generate
profits. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA or another third-country
competent authority. We may initiate voluntary recalls involving our products in the future that we determine do not require notification
of the FDA or another third-country competent authority. If the FDA disagrees with our determinations, they could require us to report
those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect our sales. In addition,
the FDA could take enforcement action for failing to report recalls. We are also required to follow detailed recordkeeping requirements
for all firm-initiated medical device corrections and removals.

Even though we have received breakthrough
device designation for the Hemopurifier for two independent indications, this designation may not expedite the development or review of
the Hemopurifier and does not provide assurance ultimately of PMA submission or approval by the FDA.

The Breakthrough Devices Program
is a voluntary program intended to expedite the review, development, assessment and review of certain medical devices that provide for
more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions for which no approved
or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives. All submissions for devices
designated as Breakthrough Devices will receive priority review, meaning that the review of the submission is placed at the top of the
appropriate review queue and receives additional review resources, as needed.

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Although breakthrough designation
or access to any other expedited program may expedite the development or approval process, it does not change the standards for approval.
Although we obtained breakthrough device designation for the Hemopurifier for two indications, we may not experience faster development
timelines or achieve faster review or approval compared to conventional FDA procedures. For example, the time required to identify and
resolve issues relating to manufacturing and controls, the acquisition of a sufficient supply of our product for clinical trial purposes
or the