Company: AEMD
Filing Date: 2025-08-29
Form Type: S-1/A
Source: 0001683168-25-006537
Chunk: 17

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-29
Form: S-1/A
Chunk 17
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in exosomal microRNAs associated with the development of coagulopathy and acute lung injury.

The second patient case study
demonstrated in vivo removal of SARS-CoV-2 virus from the blood stream of an infected patient. This patient completed a six-hour Hemopurifier
treatment without complications and subsequently was placed on continuous renal replacement therapy, or CRRT. The patient ultimately expired
three hours after being placed on CRRT because of the advanced stage of the patient’s disease.

On June 17, 2020, the FDA approved
a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19
in a New Feasibility Study. That study was designed to enroll up to 40 subjects at up to 20 centers in the United States. Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an ICU, and have acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition to safety, include reduction in circulating virus, as well as clinical outcomes (NCT 

# 04595903). In June 2022, the Company completed the treatment protocol for its first patient in this study.
In June 2022, the Company completed the treatment protocol of the only participant enrolled in the study. study. The patient received one HP treatment daily for 4 days. This patient died following cardiac arrest (not related to the HP treatment) as a consequence of severe COVID-19 pneumonia. Blood samples taken from the patient did not reveal any evidence of viremia. Plasma sent for cytokine analysis revealed a numeric decrease in the levels of IP-10, MCP-1, and IL-10.

| 6 |

A similarly designed trial was
also conducted in India. One patient was enrolled on February 16, 2022, at Medanta Medicity Hospital, Gurugram, Haryana 12200, India.
The patient tolerated one HP treatment daily for three days. On 19 February 2022, in the first 15 min during the 3rd treatment, one nonserious
Grade 2 AE was reported (hemolysis and leaking of the filter). The filter was replaced, and therapy resumed without sequalae. On Day #4
the patient suffered asystole and died due to clinical deterioration unrelated to the device. During the