Medical Technology Breaking News: Aethlon Medical (OTCBB:
AEMD) Announces Ebola Humanitarian Use Device Submission to the FDA
SAN DIEGO - April 9, 2015 (Investorideas.com newswire)
Aethlon Medical, Inc. (OTCBB:AEMD), a pioneer in developing targeted therapeutic
devices to address infectious diseases and cancer, announced today that it has
submitted a Humanitarian Use Device submission to the United States Food and
Drug Administration (FDA) to support potential market clearance of the Aethlon
Hemopurifier® as a treatment for Ebola virus. The Hemopurifier is a
first-in-class bio-filtration device designed for the single-use removal of
viruses and shed glycoproteins from the circulatory system of infected
individuals. The device targets antiviral drug resistance and could serve as a
first-line countermeasure against Ebola and other viruses that are not
addressed with proven drug therapies.
A Humanitarian Use Device (HUD) is intended to benefit
patients by treating or diagnosing a disease or condition that affects or is
manifested in fewer than 4,000 individuals in the United States per year. If
the HUD application is designated by the FDA, Aethlon may then submit a
Humanitarian Device Exemption (HDE) marketing application to the Center for
Devices and Radiological Health (CDRH) for marketing review. There is no
assurance that Aethlon will receive HDE approval to market the Hemopurifier as
a treatment for Ebola virus.
Read this release
in full at http://www.investorideas.com/CO/AEMD/news/2015/04091.asp
About Aethlon Medical, Inc.
Aethlon
Medical creates medical devices that target unmet therapeutic needs in
infectious disease and cancer. The company's lead product is the Aethlon
Hemopurifier®, a first-in-class device that selectively targets the rapid elimination
of circulating viruses and tumor-secreted exosomes that promote cancer
progression. Exosome Sciences, Inc. is a majority owned subsidiary that is
advancing exosome-based products to diagnose and monitor cancer, infectious
disease and neurological disorders. Additional information can be found on-line
at http://www.aethlonmedical.com/ and connect with
the Company on Twitter, LinkedIn, Facebook and Google+.
Certain
statements herein may be forward-looking and involve risks and uncertainties.
Such forward-looking statements involve assumptions, known and unknown risks,
uncertainties and other factors which may cause the actual results, performance
or achievements of Aethlon Medical, Inc. to be materially different from any
future results, performance, or achievements expressed or implied by the
forward-looking statements. Such potential risks and uncertainties include,
without limitation, that Exosome Sciences, Inc. will not be able to
commercialize its future products, including any that can be described as a
liquid biopsy, that the FDA will not approve the initiation of the Company's
clinical programs or provide market clearance of the company's products, future
human studies whether revenue or non-revenue generating of the Aethlon ADAPT™
system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient
responsiveness to established cancer or hepatitis C therapies or as a
standalone cancer or hepatitis C therapy or as a broad spectrum defense against
viral pathogens, including Ebola, the Company's ability to raise capital when
needed, the Company's ability to complete the development of its planned
products, the Company's ability to manufacture its products either internally
or through outside companies and provide its services, the impact of government
regulations, patent protection on the Company's proprietary technology, the
ability of the Company to meet the milestones contemplated in the DARPA contract,
product liability exposure, uncertainty of market acceptance, competition,
technological change, and other risk factors. In such instances, actual results
could differ materially as a result of a variety of factors, including the
risks associated with the effect of changing economic conditions and other risk
factors detailed in the Company's Securities and Exchange Commission filings.
The Company undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events, or otherwise.
Contacts:
David
Zazoff
MDM Worldwide Solutions
646-403-3554
MDM Worldwide Solutions
646-403-3554
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