Company: AEMD
Filing Date: 2025-02-12
Form Type: 10-Q
Source: 0001683168-25-000960
Chunk: 10

Company: AETHLON MEDICAL INC
Filing Date: 2025-02-12
Form: 10-Q
Item: Item 1
Chunk 10
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 virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related
viruses, and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with
leading government or non-government research institutes.

On June 17, 2020, the FDA approved a supplement
to our open Investigational Device Exemption (“IDE”) for the Hemopurifier in viral disease to allow for the testing of the
Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a new feasibility study. In June 2022, the first patient in this
study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to the lack of COVID-19 patients in the ICUs of
our trial sites, we terminated this study in 2022. However, our IDE for this indication remains open, as we have an active COVID-19 trial
in India and wish to preserve the option of enrolling patients if the situation with COVID-19 changes.

Under Single Patient Emergency Use regulations,
Aethlon has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier
in our COVID-19 clinical trial discussed above.

We also obtained ethics review board (“ERB”)
approval from and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India,
for a COVID-19 clinical trial at that location. In May 2023, we received ERB approval from the Medanta Medicity Hospital and Maulana
Azad Medical College (“MAMC”), for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established
in 1958 and is located in New Delhi, India. MAMC is affiliated with the University of Delhi and is operated by the Delhi government.
In November 2024, Aethlon terminated the COVID-19 clinical trial in India due to lack of enrollment of COVID patients.

Additionally, based on preclinical data with acellular
kidney perfusates, we believe that the Hemopurifier has potential applications in organ transplantation. We are investigating whether
the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules,
cytokines