Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 1492

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 9B
Chunk 1492
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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 which contains