Aethlon Medical Inc (AEMD)

[TRUISM]

11/27/18-Aethlon Medical's Cancer Therapy Receives "Breakthrough Device" Designation from the U.S. Food and Drug Administration
Published: Nov 27, 2018 7:21 a.m. ET
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SAN DIEGO, Nov. 27, 2018 /PRNewswire/ -- Aethlon Medical, Inc. AEMD, a therapeutic technology company focused on unmet needs in global health, announced today that it has received a "Breakthrough Device" designation from the U.S. Food and Drug Administration (FDA) to support the advancement of the Aethlon Hemopurifier® for the treatment of cancer. The Aethlon Hemopurifier is 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 21 [st] 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.

"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," stated Aethlon Medical founder and CEO, Jim Joyce. "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."

Cancer is the second leading cause of death globally and is estimated to account for 9.6 million deaths in 2018 (source:World Health Organization). 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. To learn more about the Hemopurifier in cancer, click here: https://tinyurl.com/Aethlon-White-Paper.

The proposed indications for use (IFU) under the Breakthrough Device designation includes, "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 standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. Therapy with the Hemopurifier device should be an adjunct to standard of care for cancer."

Aethlon is also advancing the Hemopurifier as a candidate to treat life-threatening viruses. In this regard, the Hemopurifier was designated as a Breakthrough Device indicated for the treatment of life-threatening highly glycosylated viruses that are not addressed with an approved treatment.





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