AETHLON MEDICAL, INC. (NASDAQ:AEMD) Files An 8-K Other EventsITEM 8.01 Other Events
On November 13, 2017, the Food and Drug Administration (“FDA”) confirmed receipt of Aethlon Medical, Inc.’s (the “Company”) Investigational Device Exemption (IDE) Final Report (IDE G070038/R3) concerning the use of the Aethlon Hemopurifier® Device in the treatment of chronic end-stage renal disease patients with Hepatitis-C (HCV) infection. The primary objective of the study was to determine whether therapy with the Hemopurifier is safe in health-compromised virally-infected individuals based on a relative absence of device-related adverse events. Based on the review of reported adverse events, there were no significant device related adverse events in enrolled subjects who met the study inclusion/exclusion criteria. Additionally, there was no significant difference in the hematology, clinical chemistry, and inflammatory marker results between the control period and treatment period of enrolled subjects. There were also no significant changes related to BMI or other vital signs when comparing pre-and post-treatment values. The clinical trial authorized by the above-referenced IDE was a single site study conducted at DaVita Medical Center in Houston, Texas. The study enrolled and treated eight subjects who met the inclusion/exclusion criteria and was concluded in March 2017.
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.
