Company: AEMD
Filing Date: 2025-07-25
Form Type: DRS
Source: 0001683168-25-005397
Chunk: 16

Company: AETHLON MEDICAL INC
Filing Date: 2025-07-25
Form: DRS
Chunk 16
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ations by the treating physician indicated that 242 million copies
of Ebola virus were captured within the Hemopurifier during treatment. The patient made a full recovery. Based on this experience, the
Company filed an Expanded Access protocol with the FDA to treat Ebola virus infected patients in up to ten centers in the United States
and a corresponding protocol was approved by HealthCanada. These protocols remain open, allowing Hemopurifier treatment to be offered
to patients presenting for care in both countries. In 2018, the FDA designated the Hemopurifier as a Breakthrough Device “…
for the treatment of life-threatening viruses that are not addressed with approved therapies.”

Severe Acute SARS-CoV-2/COVID-19 Infection–
Emergency Use and Clinical Trials

SARS-COV-2, the causative
agent of COVID-19 is a member of the coronavirus family, which includes the original SARS virus, SARS-CoV, and the MERS virus. SARS-CoV-2,
found to contain mannose on the envelope surface. This suggests that the Hemopurifier could potentially clear it from biological fluids,
including blood.

Under Single Patient Emergency
Use regulations, we have treated two patients with COVID-19 with the Hemopurifier. We published a manuscript reviewing case studies covering
those two Single Patient Emergency Use treatments entitled “Removal of COVID-19 Spike Protein, Whole Virus, Exosomes and Exosomal
microRNAs by the Hemopurifier® Lectin-Affinity Cartridge in Critically Ill Patients with COVID-19 Infection” in the peer-reviewed
journal Frontiers in Medicine.

The manuscript described the
use of the Hemopurifier for a total of nine sessions in two critically ill COVID-19 patients. The first case study demonstrated the improvement
in the patient who was a SARS-COV-2 positive COVID-19 present at entry to the hospital, with associated coagulopathy, or CAC, lung injury,
inflammation, and tissue injury despite the absence of demonstrable COVID-19 viremia at the start of treatment at Day 22.This patient
received eight Hemopurifier treatments without complications and eventually was weaned from a ventilator and was discharged from the hospital.
Plasma samples from this patient revealed a decrease in extracellular vesicle counts over the course of the eight treatments and decreases
in exosomal microRNAs associated with the development of coagulopathy and acute lung injury.

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