Company: AEMD
Filing Date: 2025-08-20
Form Type: S-1
Source: 0001683168-25-006352
Chunk: 14

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-20
Form: S-1
Chunk 14
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 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.

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 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 Hemop