Healthcare Industry News: Fresenius Medical Care
News Release - March 6, 2007
Aethlon Medical Announces FDA SubmissionSAN DIEGO--(HSMN NewsFeed)--Aethlon Medical, Inc. (OTCBB:AEMD ), a pioneer in developing therapeutic devices for infectious disease, announced today 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).
About Aethlon Medical
Aethlon Medical has developed a first-in-class medical device to treat infectious disease. The device, known as the Hemopurifier®, 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 (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® 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.
Source: Aethlon Medical
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