Breakthrough designation for HemopurifierFebruary 4, 2019
Aethlon Hemopurifier for the treatment of cancer has been granted breakthrough device designation from the US FDA. The Hemopurifier is a first-in-class technology designed for the rapid depletion of cancer-promoting exosomes and life-threatening viruses.
FDA’s Breakthrough Device programme was established under the 21st Century Cures Act to facilitate more rapid patient access to breakthrough technologies with the potential to address life-threatening disease conditions for which no approved or cleared treatment alternatives exist.
Aethlon has recently demonstrated the ability of the Hemopurifier to capture exosomes underlying several forms of cancer, including breast, ovarian and metastatic melanoma.
The Hemopurifier is a single-use device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of the standard of care therapy and with cancer types in which exosomes have been shown to participate in the development or severity of the disease, according to the company.