FDA OKs Aethlon to Export Hemopurifier to India

@font-face { font-family: “Times”; }@font-face { font-family: “Cambria”; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: “Times New Roman”; }div.Section1 { page: Section1; }

Aethlon Medical, Inc. received the OK from the U.S. Food and Drug Administration (FDA) to export its Hemopurifier medical device to India.

The FDA’s approval was granted under Section 801 (e) of the Federal Food, Drug, and Cosmetic Act, as amended (the Act). Section 801 (e) of the Act covers class III medical devices, such as the Hemopurifier, that have not yet been approved in the United States by the FDA. Section 801 (e) applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices.

“The granting of our export license by FDA represents a critical step in our strategy to initiate future commercialization of our Hemopurifier in India,” said Jim Joyce, Aethlon’s chairman and CEO.

San Diego, Calif.-based Aethlon currently is conducting a clinical study called: “Use of the Aethlon Hemopurifier in Treating Chronic HCV Infection in Combination with Standard of Care Drug Therapy” at the Medicity Institute (Medicity) near Delhi, India. HCV is the medical abbreviation for Hepatitis C. Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India.

A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier is able to accelerate the benefit of HCV standard-of-care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy, according to the company. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates. Upon demonstration of treatment efficacy, Aethlon plans to commence commercialization of its Hemopurifier in India.

Clinical studies also are ongoing in the United States and Europe.