Aethlon Medical Submits Investigational Device Exemption To The FDA
SAN DIEGO - Aethlon Medical, Inc. (OTCBB:AEMD), a pioneer in developing therapeutic devices for infectious disease, has announced it has submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) requesting permission to initiate human safety studies of the Aethlon Hemopurifier® as a treatment countermeasure against select category “A” bioterror threats. Category “A” bioterror threats are defined by The Centers for Disease Control and Prevention (CDC) as agents that pose a risk to national security, are easily disseminated or transmitted from person to person, result in high mortality rates, could cause public panic and social disruption, and require special action for public health preparedness.
“The submission of our IDE represents a significant milestone in our effort to commercialize the Hemopurifier® in the United States,” stated James A. Joyce, Chairman and CEO of Aethlon Medical. “I am extremely proud of our team,” continued Joyce. “They managed to deliver the IDE ahead of schedule, while advancing new collaborations with researchers representing the United States and the Government of India,” concluded Joyce.
Aethlon also announced that Dr. Nathan Levin, Director of the Renal Research Institute (RRI) in New York City, has agreed to be Principal Investigator of the studies. The RRI is a joint venture between Fresenius Medical Care, the global leader in the dialysis industry, and Beth Israel Medical Center. Pending internal review board approval, the proposed study is to occur at Beth Israel Medical Center, also based in New York City. “We are very pleased to have Dr. Levin serve as our principal investigator,” stated Dr. Hal Handley, President of Aethlon Medical. “Dr. Levin is a world-renowned authority in renal care and a recognized thought leader in advancing new technologies for the betterment of medical care in the United States and abroad,” concluded Handley.
Additional studies to demonstrate the utility of the Hemopurifier® as a countermeasure against category “A” bioterror threats have been initiated with researchers at the CDC, The United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and the Southwest Foundation for Biomedical Research (SFBR).
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