Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 55

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 55
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 one or more large claims against us that exceeds our available insurance coverage, or results
in changes to our insurance policies, including premium increases or the imposition of large excess or deductible or co-insurance requirements,
could have a material adverse impact on our business, results of operations and financial condition.

In addition to experiencing
a Security Breach, third parties may gather, collect, or infer Sensitive Information about us from public sources, data brokers, or other
means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or
market position.

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Should our products be approved for commercialization,
lack of third-party coverage and reimbursement for our devices could delay or limit their adoption.

In both the U.S. and international
markets, the use of medical devices is dependent in part on the availability of reimbursement from third-party payors, such as government
and private insurance plans. Healthcare providers that use medical devices generally rely on third-party payors to pay for all or part
of the costs and fees associated with the medical procedures being performed or to compensate them for their patient care services. Should
our products under development be approved for commercialization by the FDA, any such products may not be considered cost-effective, reimbursement
may not be available in the United States or other countries, if approved, and reimbursement may not be sufficient to allow sales of our
future products, including the Hemopurifier, on a profitable basis. The coverage decisions of third-party payors will be significantly
influenced by the assessment of our future products by health technology assessment bodies. These assessments are outside our control
and any such evaluations may not be conducted or have a favorable outcome.

If approved for use in the
United States, we expect that any products that we develop, including the Hemopurifier, will be purchased primarily by medical institutions,
which will in turn bill various third-party payors for the health care services provided to patients at their facility. Payors may include
the Centers for Medicare & Medicaid Services, or CMS, which administers the Medicare program and works in partnership with state governments
to administer Medicaid, other government programs and private insurance plans. The process involved in applying for coverage and incremental
reimbursement from CMS is lengthy and expensive. Further, Medicare coverage is based on our ability to demonstrate that the treatment
is “reasonable and necessary” for Medicare beneficiaries. Even if products utilizing our Aethlon Hemopurifier technology receive
FDA and other regulatory clearance or approval