Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 5

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1
Chunk 5
---
 premarket approval of all
medical devices.

In our current applications,
our Hemopurifier can be used with approved dialysis machines serving as a blood pump. It could also potentially be developed as part of
a proprietary closed system with its own pump and tubing set, negating the requirement for dialysis infrastructure.

The Hemopurifier - Clinical Experience

Hepatitis C and HIV

The initial clinical development
of the Hemopurifier focused on the viral infections Hepatitis C and HIV. Clinical trials conducted in India and a safety trial demonstrated
the removal of both viruses from the bloodstream with a benign safety profile. Prior to FDA approval of the IDE feasibility study, we
conducted investigational HCV treatment studies at the Apollo Hospital, Fortis Hospital, and the Medanta Medicity Institute in India.
In the Medanta Medicity Institute study, 12 HCV-infected individuals were enrolled to receive three six-hour Hemopurifier treatments during
the first three days of a 48-week peginterferon+ribavirin treatment regimen. The study was conducted under the leadership of Dr. Vijay
Kher. Dr. Kher’s staff reported that Hemopurifier therapy was well tolerated and without device-related adverse events in the 12
patients treated.

 3 

Of these 12 patients, ten
completed the Hemopurifier-peginterferon+ribavirin treatment protocol, including eight genotype-1 patients and two genotype-3 patients.
Eight of the ten patients achieved a sustained virologic response, which is the clinical definition of treatment cure and is defined as
undetectable HCV in the blood 24 weeks after the completion of the 48-week peginterferon+ribavirin drug regimen. Both genotype-3 patients
achieved a sustained virologic response, while six of the eight genotype-1 patients achieved a sustained virologic response, which defines
a cure of the infection. Our IDE safety study in end stage renal disease patients on dialysis who were infected with HCV was conducted
at DaVita MedCenter Dialysis in Houston, Texas. We reported that there were no device-related adverse events in enrolled subjects who
met the study inclusion-exclusion criteria. We also reported that an average capture of 154 million copies of HCV (in International Units,
I.U.) within the Hemopurifier during four-hour treatments.

The initial clinical development
of the Hemopurifier was focused on the