Aethlon Medical, Inc.

Aethlon Medical, Inc. is a medical therapeutic company that develops the Hemopurifier® (HP), a clinical-stage investigational immunotherapeutic device. This device is designed to address unmet needs in oncology, life-threatening infectious diseases, organ transplantation, and other disease states where extracellular vesicles (EVs) contribute to disease progression. The Hemopurifier uses a proprietary lectin-based technology to bind and remove enveloped viruses and EVs from biological fluids. EVs have been linked to immune suppression, metastasis, and therapy resistance in cancer, as well as the progression of severe infectious diseases. Pre-clinical studies have shown the Hemopurifier can bind disease-associated EVs and a range of enveloped viruses. The Hemopurifier has been evaluated in human studies, involving 173 treatment sessions in 44 patients with either viral infections or cancer. The device was well tolerated, with an adverse event profile consistent with extracorporeal therapy. Certain human studies designed to evaluate viral clearance from biological fluids demonstrated the removal of enveloped viruses. The U.S. Food and Drug Administration (FDA) has granted the Hemopurifier "Breakthrough Device" designation for two indications: the treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy, and the treatment of life-threatening viruses not addressed with approved therapies. Aethlon Medical, Inc. is currently advancing clinical development activities for the Hemopurifier in oncology and evaluating its potential in additional applications based on its mechanism of action and preclinical studies. The company is evaluating the Hemopurifier as a potential treatment for patients with advanced and metastatic cancer by binding to and removing EVs that may promote tumor growth and metastasis. In October 2022, a wholly-owned subsidiary was formed in Australia to support oncology-related clinical research and pursue regulatory approval and potential regulatory and commercialization opportunities for the Hemopurifier.