Aethlon Medical, Inc. (NASDAQ: AEMD) loomed large Tuesday morning, after the company's cancer therapy received Breakthrough Device designation from the U.S. Food and Drug Administration.
The San Diego-based company points to the Aethlon Hemopurifier as a first-in-class technology designed for the rapid depletion of cancer-promoting exosomes and life-threatening viruses.
FDA's Breakthrough Device program 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.
CEO Jim Joyce said, "We are honored to receive this breakthrough designation in oncology as it establishes an opportunity to expand the market for our Hemopurifier and advance our vision for addressing a significant unmet need in cancer care.
"By reducing the presence of tumor-derived exosomes from the circulatory system of cancer patients, we believe our Hemopurifier can improve the benefit of existing cancer treatment regimens and emerging immuno-oncology drugs, thus providing a rationale for potential partnering opportunities."
The World Health Organization calls cancer the second leading cause of death globally and is estimated to account for 9.6 million deaths in 2018
Tumor-derived exosomes, which are not addressed with an approved therapy, have been discovered to promote immune suppression, seed the spread of metastasis and inhibit the benefit of many leading cancer therapies. Aethlon has recently demonstrated the ability of the Hemopurifier to capture exosomes underlying several forms of cancer, including breast, ovarian and metastatic melanoma.
AEMD shares raced higher 31 cents, or 26.3% to $1.48
