The contract, funded in phases and could be as large as $22.83 million and last as long as four years -- is for leading one of DARPA's DLT System Integration projects. The project calls for Battelle and key subcontractors, NxStage and Aethlon, to design, develop, test and validate an advanced, portable medical device that exhibits the technical innovation for which DARPA projects are known, and to coordinate integration of key technologies developed during the overall DLT program. This funding does not include human clinical trials that may be required prior to military use and/or United States Food and Drug Administration clearance for sepsis-treatment technologies.
The company also reported in July FDA approval of an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in the United States. The Hemopurifier ® is a first-in-class medical device that targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation.
Under the feasibility study protocol, Aethlon will enroll ten end stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease conditions.
About Aethlon Medical (OTCQB: AEMD)
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT product pipeline includes the Aethlon Hemopurifier to address infectious disease and cancer, and a medical device being developed under a 5-year contract with DARPA to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
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