Aethlon Medical Announces FDA Submission.SAN DIEGO -- Aethlon Medical, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AEMD), a pioneer in developing therapeutic devices for infectious disease, announced today it has submitted an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) requesting permission to initiate human safety studies of the Aethlon Hemopurifier([R])as a treatment countermeasure against select category "A" bioterror threats. Category "A" bioterror threats are defined by The Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (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([R])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 The Government of India (Hindi: भारत सरकार [3]Bhārat Sarkār), officially referred to as the Union Government, and commonly as Central Government ," concluded Joyce. Aethlon also announced that Dr. Nathan Levin, Director of the Renal Research Institute (RRI) in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , has agreed to be Principal Investigator of the studies. The RRI is a joint venture between Fresenius Medical Care Fresenius Medical Care is a German company specializing in the production of medical supplies, primarily to facilitate or aid renal dialysis. It is 37%-owned by the health care company Fresenius SE. , the global leader in the dialysis industry, and Beth Israel Medical Center Beth Israel Medical Center is a hospital in New York City. It has four major locations providing health services. It acts as University Hospital and Manhattan Campus for the Albert Einstein College of Medicine of Yeshiva University. . 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([R])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 The United States Army Medical Research Institute of Infectious Diseases (USAMRIID, pronounced you-SAM-rid) is a military research institute for medicine based at Fort Detrick, Frederick, Maryland used for research of infectious disease that may have defensive applications against (USAMRIID USAMRIID United States Army Medical Research Institute of Infectious Diseases (US DoD) ), and the Southwest Foundation for Biomedical Research Southwest Foundation for Biomedical Research (SFBR) is a large private research institute located in San Antonio Texas. With 400 staff and a 397 acre campus, SFBR is "one of the world's leading independent biomedical research institutions. (SFBR). About Aethlon Medical Aethlon Medical has developed a first-in-class medical device to treat infectious disease. The device, known as the Hemopurifier([R]), is a broad-spectrum treatment countermeasure against drug- and vaccine-resistant bioweapons, naturally evolving pandemic threats, and chronic infectious disease targets including Hepatitis-C (HCV) and the Human Immunodeficiency Virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. (HIV). Global researcher Frost & Sullivan awarded Aethlon the 2006 Technology Innovation Award for its advances in the field of biodefense. The company has also initiated research on a second-generation Hemopurifier([R]) that targets the capture of growth factors inherent in the spread of Cancer. More information on Aethlon Medical and the Hemopurifier(TM) technology can be found at www.aethlonmedical.com. Certain of the statements herein may be forward looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. |
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