SAN DIEGO, March 8, 2011 /PRNewswire/ — Aethlon Medical, Inc.
(OTC Bulletin Board:
AEMD), the pioneer in developing therapeutic filtration devices
to address infectious disease and cancer, announced today that the
U.S. Food and Drug Administration (FDA) has granted Aethlon’s
request to export its Hemopurifier® medical device to
India.
(Photo: http://photos.prnewswire.com/prnh/20090325/LA88762LOGO-b)
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 received an
approved Premarket Approval in the US 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,” stated Jim Joyce, Aethlon Chairman and
CEO.
Aethlon is currently conducting a clinical study entitled: “Use
of the Aethlon Hemopurifier® in Treating Chronic HCV Infection
in Combination with Standard of Care (SOC) Drug Therapy” at the
Medicity Institute (Medicity) near Delhi, India. The 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 t
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