Investorideas.com (www.investorideas.com newswire) a trusted platform for investing ideas including biotech and
medical tech stocks reports breaking 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(R) 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.
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(R)
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
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