Company: AEMD
Filing Date: 2025-09-05
Form Type: 424B4
Source: 0001683168-25-006701
Chunk: 30

Company: AETHLON MEDICAL INC
Filing Date: 2025-09-05
Form: 424B4
Chunk 30
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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 the
various components of the Hemopurifier with materials from our various suppliers, which are purchased and released by Aethlon. Specifically,
the Hemopurifier contains three critical components with limited available suppliers. The GNA lectin is sourced from Vector Laboratories
Inc. and also is available from other suppliers. Our intended transition from Vector Laboratories to a new supplier for GNA is delayed
as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing change. The base cartridge
on which the Hemopurifier is constructed is sourced from Medica S.p.A and we are dependent on the continued availability of these cartridges.
Although there are other suppliers, the process of qualifying a new supplier takes time and regulatory approvals must be obtained. We
currently purchase the diatomaceous earth from Janus Scientific, Inc., as the distributor; however, the product is manufactured by Imerys
Minerals Ltd. There potentially are other suppliers of this product, but as with the cartridges, qualifying and obtaining required regulatory
approvals takes time and resources.

Sales and Marketing

We do not currently have