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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