Company: AEMD
Filing Date: 2025-07-25
Form Type: DRS
Source: 0001683168-25-005397
Chunk: 11

Company: AETHLON MEDICAL INC
Filing Date: 2025-07-25
Form: DRS
Chunk 11
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, and the reconstructed 1918 Spanish flu virus. In several cases, these studies
were conducted in collaboration with leading government or non-government research institutes.

The Hemopurifier has previously
been studied under FDA and international regulatory frameworks for the treatment of severe SARS-CoV-2 infection. While we terminated our
U.S. and India-based COVID-19 studies due to low ICU patient volume and shifting priorities, these programs demonstrated real-world use
of the Hemopurifier in critically ill patients. We maintain an open IDE for viral indications to preserve optionality for future outbreaks
or emergent pathogens.

We have sufficient inventory
of Hemopurifiers to support our ongoing oncology trial in Australia as well as any near-term expansion of that study or potential trial
activity in India. While we have received FDA approval to begin manufacturing at our San Diego facility under our IDE supplement, we are
still awaiting FDA approval of a separate supplement to qualify an additional supplier of a key Hemopurifier component. We continue to
work with the FDA on this process.

Pre-Clinical Exploration of Additional Clinical Uses for the Hemopurifier

The Aethlon R&D laboratory
continues to explore potential new indications for the Hemopurifier. We have published in the peer-reviewed journal Transplant Immunology the ability of the device to remove extracellular vesicles and their microRNA cargo from acellular perfusates of discarded
kidneys that had undergone normothermic machine perfusion.

On May 12, 2025, the results
of our pre-clinical ex vivo study entitled “Ex Vivo Removal of CD41 positive platelet microparticles from Plasma by a Medical Device
containing a Galanthus nivalis agglutinin (GNA) affinity resin” were published in the pre-print vehicle bioRxiv. This manuscript
has been submitted to a peer-reviewed publication for review.

Platelet-derived extracellular
vesicles (PD-EVs) are the most numerous EV population in the body and are released by platelets in response to a variety of stimuli. The
cargo contained within these EVs have been noted to take part in damage to blood vessels, activation of immune cells and spread of tumor
cells. Excessive levels of PD-EVs have been implicated in a myriad of diseases including cancer, lupus, systemic sclerosis, multiple sclerosis,
Alzheimer’s disease, sepsis, acute and Long COVID.

We hypothesized that
the Aethlon Hemopurifier