Research & Development
FDA Grants Aethlon Medical EAP Designation for its Hemopurifier as Treatment for Life-Threatening Viruses
13 September 2017 - - San Diego, California-based medical device company Aethlon Medical, Inc. (NASDAQ: AEMD) has received an Expedited Access Pathway (EAP) designation from the United States Food and Drug Administration to support the advancement of the Aethlon Hemopurifier to treat life-threatening viruses, the company said. 
The Aethlon Hemopurifier was designed to reduce the presence of life-threatening viral pathogens from the circulatory system of infected individuals. The technology provides a first-line candidate defense against viruses that are not addressed with approved therapies, including a broad-spectrum of naturally occurring pandemic threats and agents of bioterrorism.
Aethlon proposed the following indication for use in its EAP submission: "The Hemopurifier is a single-use device indicated for the treatment of life-threatening highly glycosylated viruses that are not addressed with an approved treatment." 
To date, the Hemopurifier has been validated to capture a broad-spectrum of viruses that are highly glycosylated, including life-threatening strains of pandemic influenza viruses, mosquito-borne viruses as well as hemorrhagic viruses that are not addressed with an approved treatment.
Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA's PMA approval standard of reasonable assurance of safety and effectiveness.
Aethlon Medical is focused on addressing unmet needs in global health and biodefense. The company is also investigating the potential use of the Hemopurifier to reduce the presence of tumor-derived exosomes, which contribute to immune-suppression and the spread of metastasis in cancer patients. 
Aethlon Medical is the majority owner of Exosome Sciences, Inc., which is a diagnostic company focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disorders, including Alzheimer's disease and chronic traumatic encephalopathy. 
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