Aethlon Medical, Inc. (AEMD), a clinical-stage medical device firm, announced that it is prepared to engage with global healthcare and regulatory authorities regarding the potential investigational use of its Hemopurifier technology, as it is currently monitoring developments related to the current Bundibugyo Ebola virus outbreak in the Democratic Republic of the Congo and Uganda.
Following the news, AEMD is trading up 6.36% at $2.34 in the pre-market.
Aethlon's Hemopurifier is an investigational extracorporeal medical device designed to remove enveloped viruses and tumour-derived EVs from circulation. Notably, Hemopurifier has the FDA's Breakthrough Device Designation for the treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy, and for the treatment of life-threatening viruses not addressed by approved therapies.
As per WHO reports, the current Ebola outbreak involves the Bundibugyo strain, for which there are no licensed vaccines or strain-specific treatments, and clinical management is primarily based on supportive care.
The firm highlighted the incident in 2014, in which the Hemopurifier was administered to a critically ill Ugandan physician treated at Frankfurt University Hospital under emergency-use circumstances.
The firm noted that the patient's viral load reportedly declined from approximately 400,000 Ebola virus copies per millilitre of blood to approximately 1,000 copies per millilitre of blood following a single 6.5-hour Hemopurifier treatment. The findings were also presented at the American Society of Nephrology Annual Meeting in 2014.
Meanwhile, investigative 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 on a case-by-case basis.
The firm added that it will continue to monitor the evolving Ebola situation and respond accordingly to any requests from treating clinicians.
AEMD has traded between $1.36 and $32.00 over the last year. The stock closed Friday's trade at $2.2O, up 4.76%.
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