Ebola
Outbreak Spotlights Aethlon Medical’s (Nasdaq: $AEMD) Advanced Preparedness
Technology
(Investorideas.com Newswire) Investorideas.com, a
leading investment platform for retail investors reports breaking Medical Tech
Stock news for Aethlon Medical, Inc. (Nasdaq: AEMD),
a medical therapeutic company focused on developing products to treat
cancer and life-threatening infectious diseases.
Aethlon Medical, Inc. (NASDAQ: AEMD) today announced that it is actively
monitoring developments related to the current Bundibugyo Ebola virus outbreak
in Democratic Republic of the Congo and Uganda and remains prepared to engage
with global healthcare and regulatory authorities regarding the potential
investigational use of its Hemopurifier® technology.
According to recent reports from the World Health
Organization (“WHO”) and other public health agencies, the current outbreak has
been identified as involving the Bundibugyo strain of Ebola virus, a strain for
which we are not aware of any approved treatments beyond supportive care, as of
the date of this release. Health authorities continue to express concern
regarding cross-border transmission and the potential for broader regional
spread. Public health
assessments, including regarding potential cross-border transmission, are
evolving and subject to change.
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Aethlon’s Hemopurifier is an investigational
medical device designed to remove enveloped viruses and tumor-derived EVs from
circulation. During the 2014 Ebola (Zaire strain) outbreak, the Hemopurifier
was successfully administered to a critically ill Ugandan physician treated at
Frankfurt University Hospital under emergency-use circumstances.
At the time Hemopurifier therapy was initiated, the
physician was unconscious and suffering from multiple organ failure requiring
mechanical ventilation, vasopressor support and continuous dialysis. Following a
single 6.5-hour Hemopurifier treatment, the patient’s viral load reportedly
declined from approximately 400,000 Ebola virus copies per milliliter of blood
to approximately 1,000 copies per milliliter of blood. The Ebola virus
subsequently became undetectable five days following treatment. Testing
performed after this treatment indicated that the Hemopurifier captured Ebola virus during therapy;
quantitative estimates reported at the time, were approximately 242 million
virions. The patient ultimately made recovered and returned home to Uganda.
That treatment data was presented at the American
Society of Nephrology Annual Meeting on November 14, 2014 by Helmut Geiger,
M.D., Chief of Nephrology at Goethe University, Frankfurt University Hospital.
In the United States, Hemopurifier therapy has
previously been made available for Ebola patients through FDA expanded access
emergency-use provisions applicable to life-threatening circumstances where
alternative therapies may not be available. In January 2015, the U.S. Food and
Drug Administration approved an Investigational Device Exemption (“IDE”)
supplement that established a regulatory pathway for the potential
investigational use of Hemopurifier therapy in Ebola-infected individuals in
the United States, subject to applicable institutional approvals and patient
protection procedures.
Investigational use of medical technologies such as
the Hemopurifier may proceed through physician-directed emergency and
compassionate-use procedures subject to applicable hospital and regulatory
oversight.
“We believe the current Ebola outbreak reinforces
the ongoing need for broad-spectrum therapeutic approaches capable of
addressing viral threats where approved drug therapies or vaccines may be
limited,” stated James B. Frakes, Chief Executive Officer of Aethlon Medical.
“While the Hemopurifier remains investigational for Ebola treatment, the prior
clinical experience on one patient in Germany demonstrated the potential for
rapid viral reduction in a critically ill patient under emergency-use
conditions.”
The Company stated that it will continue to monitor
the evolving Ebola situation and will respond to questions or requests from
treating clinicians.
About the Hemopurifier®
The Aethlon Hemopurifier is an investigational
medical device designed to remove enveloped viruses and tumor-derived EVs from
circulation. It is used extracorporeally with a blood pump and combines plasma
separation, size exclusion, and affinity binding using a plant lectin resin
that targets mannose-rich surfaces found on EVs and viruses. EVs released by
solid tumors are believed to play a role in metastasis and the resistance to
immunotherapies and chemotherapy. Removal of enveloped viruses and
extracellular vesicles has been demonstrated in both vitro studies and human
subjects.
The Hemopurifier holds a U.S. Food and Drug
Breakthrough Device for:
·
The
treatment of individuals with advanced or metastatic cancer unresponsive to or
intolerant of standard-of-care therapy; and
·
The
treatment of life-threatening viruses not addressed with approved therapies.
The Hemopurifier is being developed under an open IDE
for both indications.
About Aethlon Medical, Inc.
Aethlon Medical, Inc. (Nasdaq: AEMD) is a clinical
stage medical device company headquartered in San Diego, California. Aethlon is
advancing the Hemopurifier, to address unmet needs in oncology and infectious
disease, using a novel platform designed to selectively remove circulation
pathogenic targets from biologic fluids. For more information visit www.AethlonMedical.com and follow the company on LinkedIn.
Forward Looking Statements
This press release
contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934
that involve risks and uncertainties. Statements containing words such as
"may," "believe," "anticipate,"
"expect," "intend," "plan," "project,"
"will," "projections," "estimate,"
"potentially" or similar expressions constitute forward-looking
statements. Forward-looking statements in this press release include but are not limited to statements
regarding Aethlon’s active monitoring of developments related to the current
Bundibugyo Ebola virus outbreak in the Democratic Republic of the Congo and
Uganda; potential engagement and responsiveness to inquiries from treating
clinicians and hospitals; potential interactions with global healthcare and
regulatory authorities concerning potential investigational use of the Hemopurifier
technology; the investigational status of the Hemopurifier for Ebola;
references to prior emergency-use and FDA expanded access pathways; and the
Company’s development plans, regulatory pathway, and potential applications of
the Hemopurifier, including its Breakthrough Device designation and ongoing
development under an (IDE for oncology and life‑threatening viral indications. Such
forward-looking statements are subject to significant risks and uncertainties
and actual results may differ materially from the results anticipated in the
forward-looking statements. These forward-looking statements are based upon
Aethlon's current expectations and involve assumptions that may never
materialize or may prove to be incorrect. Factors that may contribute to such
include, without limitation, the need for and availability of
physician-directed emergency or compassionate-use procedures; the requirement
for and timing of applicable hospital and regulatory oversight, including
institutional approvals and patient protection procedures; uncertainties
inherent in investigational use of medical technologies; device performance,
deficiencies, or immediate complications; clinical operations, logistics, and
timing (including enrollment and access to eligible patients); the status of
alternative therapies or supportive care; and the Company’s development plans,
regulatory pathway, and potential applications of the Hemopurifier. The
foregoing list of risks and uncertainties is illustrative but is not
exhaustive. Additional factors that could cause results to differ materially
from those anticipated in forward-looking statements can be found under the
caption "Risk Factors" in the Company's Annual Report on Form 10-K
for the year ended March 31, 2025, and in the Company's other filings with the
Securities and Exchange Commission, including its quarterly Reports on Form
10-Q. All forward-looking statements contained in this press release speak only
as of the date on which they were made. Except as may be required by law, the
Company does not intend, nor does it undertake any duty, to update this
information to reflect future events or circumstances. Breakthrough Device
designation expedites interaction with FDA but does not represent FDA clearance
or approval and does not, by itself, establish safety or effectiveness. The
findings described herein are preliminary in nature, have not been
peer-reviewed, and may not be replicated in subsequent studies or clinical
trials. Additional data would be required to assess safety and effectiveness.
Company Contact:
Jim Frakes
Chief Executive
Officer and Chief Financial Officer
Aethlon Medical,
Inc.
Jfrakes@aethlonmedical.com
Investor Contact:
Susan Noonan
S.A. Noonan
Communications, LLC
susan@sanoonan.com
Aethlon Medical Inc. (Nasdaq:AEMD) is
a featured biotech stock on Investorideas.com
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