Company: AEMD
Filing Date: 2025-08-29
Form Type: S-1/A
Source: 0001683168-25-006537
Chunk: 33

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-29
Form: S-1/A
Chunk 33
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 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 Hemopurifier or any other 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 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. 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 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 Hemopurifier technology receive FDA and other regulatory
clearance or approval, they may not be granted coverage and reimbursement by any payor, including by CMS. Many private payors use coverage
decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies and amounts. However,
no uniform policy for coverage and reimbursement for medical devices exists among third-party payors in the United States. Therefore,
coverage and reimbursement can differ significantly from payor to payor.

Manufacturing

Historically, manufacturing of
our Hemopurifier occurred in collaboration with a contract manufacturer based in California under current Good Manufacturing Practice,
or cGMP, regulations promulgated by the FDA. Our contract manufacturer is registered with the FDA. To date, our manufacture of the
Hemopurifier has been limited to quantities necessary to support our clinical studies.

In May 2024, the FDA approved the use of our own manufacturing
facility to manufacture Hemopurifiers.

Our costs of compliance with federal, state and local
environmental laws have been immaterial to date.

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Sources and Availability of Raw Materials and the Names of Principal Suppliers

Aethlon personnel assemble