AETHLON MEDICAL, INC. (NASDAQ:AEMD) Files An 8-K Other EventsITEM 8.01 Other Events
On August 14, 2017, Aethlon Medical, Inc. (the “Company”) received a formal receipt from the U.S. Food and Drug Administration (FDA) for its Expedited Access Pathway (EAP) program submission that was submitted to the FDA last week. The submission formally requests that the Aethlon Hemopurifier be included in the FDA EAP program.
The FDA established the EAP programformedical devices that demonstrate thepotential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. 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.
A criterion for EAP program eligibility includes medical devices that represent breakthrough technologies with the potential to address life threatening disease conditions for which no approved or cleared treatment alternatives exist. The Aethlon Hemopurifier is a medical devicedesigned for the single-use removal of viral pathogens from circulatory system of infected individuals. Based on clinical and preclinical study outcomes, the Hemopurifier is a candidate to treat abroad-spectrum oflife threatening virusesfor which no approved or cleared treatment alternativesexist.
About AETHLON MEDICAL, INC. (NASDAQ:AEMD)
Aethlon Medical, Inc. is a medical device company focused on creating devices for cancer, infectious disease and other life-threatening conditions. The Company operates through two segments: Aethlon, which represents its therapeutic business activities, and ESI, which represents its diagnostic business activities. The Company’s lead product is the Aethlon Hemopurifier, which is a device that selectively targets the elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression. The Aethlon Hemopurifier sheds glycoproteins to treat infectious viral pathogens. In oncology indications, the Hemopurifier targets the removal of circulating exosomes, which are released to promote cancer progression and to seed the spread of metastasis. Through its subsidiary, Exosome Sciences, Inc. (Exosome), the Company is also developing exosome-based product candidates to diagnose and monitor neurological disorders and cancer.