Aethlon Medical has announced that new pre-clinical data demonstrating their Hemopurifier device's ability to bind extracellular vesicles from Long COVID patients will be presented at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes in August 2025. The research, conducted in collaboration with the University of California San Francisco Medical Center Long COVID clinic, represents a potential breakthrough in addressing a condition that affects millions of Americans with no proven treatments.
Targeting Extracellular Vesicles in Long COVID
Long COVID, characterized by persistent symptoms following acute SARS-CoV-2 infection, affects between 44 and 48 million people in the United States alone, with a projected economic burden of $2 billion for those with symptoms lasting a year. Despite over $1 billion allocated to Long COVID research funding, no treatment has proven effective.
The condition manifests through symptoms including fatigue, post-exertional malaise, shortness of breath, chest pain, and cognitive difficulties such as "brain fog" that may persist for weeks or months after the initial illness. Recent research has implicated extracellular vesicles (EVs) in the pathogenesis of Long COVID. These nanoparticles, measuring 50-500nm in diameter and released from all cell types, are involved in cell-to-cell communication and have been found to contain viral particles and other cargo associated with abnormal blood clotting and inflammation.
Hemopurifier Technology and Mechanism
The Hemopurifier is an investigational extracorporeal device designed to bind and remove harmful EVs from the blood through a combination of plasma separation, size exclusion, and binding to a proprietary affinity resin containing the plant lectin Galanthus nivalis agglutinin (GNA). This lectin has previously been found to bind to the sugar mannose.
The device has previously demonstrated the ability to remove EVs in a patient with severe acute COVID-19 infection. The current study examined whether individuals with Long COVID would have EVs with the mannose target on their surface that would bind to the affinity resin in the device.
Study Design and Findings
Aethlon Medical collaborated with UC San Francisco Medical Center's Long COVID clinic to evaluate plasma samples from participants with Long COVID and control participants who had fully recovered from COVID-19. The research examined the binding capacity of both larger and smaller EVs to GNA lectin and the lectin-based affinity resin, respectively.
The study findings, to be presented in a poster titled "Extracellular Vesicles from Participants with Long COVID are Mannosylated and Bind to the Galanthus Nivalis Agglutinin Resin in the Aethlon Hemopurifier," will be presented by Dr. Steven P. LaRosa, Chief Medical Officer of Aethlon Medical, on August 12, 2025.
FDA Breakthrough Device Status
The Hemopurifier holds FDA Breakthrough Device designation for multiple indications. It is indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, specifically for cancer types in which EVs have been shown to participate in disease development or severity. The device also maintains an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.
Clinical Applications Beyond Long COVID
In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses, and in pre-clinical studies, it has shown the ability to remove harmful EVs from biological fluids using its proprietary lectin-based technology. This mechanism has potential applications in cancer, where EVs may promote immune suppression and metastasis, and in life-threatening infectious diseases.
The device is designed as a clinical stage immunotherapeutic for combating cancer and life-threatening viral infections, with additional applications in organ transplantation. The technology's ability to target EVs represents a novel approach to addressing diseases where these cellular communication vehicles play a pathogenic role.
