Aethlon Medical (NSDQ:AEMD) said today it is submitting an expedited access pathway application to the FDA seeking a breakthrough technology designation for its hemopurifier.
Aethlon’s Hemopurifier device is a single-use, disposable cartridge designed to target and filter out viruses or tumor-secreted exosomes. Blood flows through the cartridge into nearly 3,000 hollow fibers with pores 250 nanometers in diameter. A pressure deferential in the 1st third of the fiber pushes particles below 250 nanometers through the pores into a space between the fibers and the cartridge.
The San Diego, Calif.-based company said that in a recent study, the Hemopurifier was shown to successfully capture Ebola, Zika, HIV, Hepatitis C, West Nile and Flu viruses with no adverse impacts on subjects.
Aethlon said that the Hemopurifier has been verified by CDC officials to isolate and remove smallpox, Dengue, Herpes, Swine Flu and Bird Flu. The company said it hopes the initial studies will help support FDA approval for wider use.
In March, Aethlon medical said it finished the FDA-approved feasibility study for its Hemopurifier device in health-compromised patients.
The feasibility study demonstrated that the Hemopurifier was well tolerated with patients with end-stage renal disease who were also infected with Hepatitis C. There were also no device-related adverse events, according to Aethlon.
