Aethlon Medical, Inc., a pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, has submitted a Humanitarian Use Device (HUD) submission to the United States Food and Drug Administration (FDA) to support potential market clearance of the Aethlon Hemopurifier as a treatment for Ebola virus.  

The Hemopurifier is a first-in-class bio-filtration device designed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals. The device targets antiviral drug resistance and could serve as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.

A Humanitarian Use Device is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. If the HUD application is designated by the FDA, Aethlon may then submit a Humanitarian Device Exemption (HDE) marketing application to the Center for Devices and Radiological Health (CDRH) for marketing review. There is no assurance that Aethlon will receive HDE approval to market the Hemopurifier as a treatment for Ebola virus.

Aethlon Medical creates medical devices that target unmet therapeutic needs in infectious disease and cancer.