Company: AEMD
Filing Date: 2025-08-20
Form Type: S-1
Source: 0001683168-25-006352
Chunk: 25

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-20
Form: S-1
Chunk 25
---
 was used as the basis application for a Madrid registration, and the corresponding above-listed designated country registrations
can be converted to national applications to avoid abandonment.

Trademarks

In addition to the Tausome, Sansagitta
and Hemosagitta trademarks noted in the above table, we also have trademark registrations in the United States for Hemopurifier and Aethlon
Medical, Inc., and obtained a trademark registration in India for Hemopurifier. We also have common law trademark rights in Aethlon ADAPT™
and ELLSA™.

| 10 |

Industry & Competition

The industry for treating infectious
disease and cancer is extremely competitive, and companies developing new treatment procedures face significant capital and regulatory
challenges. As our Hemopurifier is a clinical-stage device, we have the additional challenge of establishing medical industry support,
which will be driven by treatment data resulting from human clinical studies. Should our device become market cleared by the FDA or the
regulatory body of another country, we may face significant competition from well-funded pharmaceutical organizations. Additionally, we
would likely need to establish large-scale production of our device in order to be competitive. Our competitors include blood filters
produced by ExThera Medical Corporation.

Government Regulation

The Hemopurifier is subject to
regulation by numerous regulatory bodies, primarily the FDA, and comparable international regulatory agencies. These agencies require
manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling,
marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting of medical devices. As the primary
mode of action of the Hemopurifier is attributable to the device component of this combination product, the CDRH has primary jurisdiction
over its premarket development, review and approval. Failure to comply with applicable requirements may subject a device and/or its manufacturer
to a variety of administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial
sanctions, such as product seizures, injunctions and criminal prosecution.

FDA’s Pre-market Clearance and Approval Requirements

Each medical device we seek to
commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, or a pre-market approval
from the FDA. Generally, if a new device has a predicate that is already on the market under a 510(k) clearance, the FDA will allow that
new device to be marketed under a 510