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Investorideas.com (www.investorideas.com newswire) is a trusted platform for investment ideas including biotech and medical tech stocks, reporting breaking news for Athlon Medical, Inc. (Nasdaq: AEMD) today announced that it is actively monitoring developments related to the current Bundibugyo Ebola virus outbreak in the Democratic Republic of Congo and Uganda and stands ready to engage with global healthcare and regulatory authorities regarding the potential investigational use of its Hemopurifier\u00ae technology.\n <\/p>\n According to recent reports from the World Health Organization (“WHO”) and other public health agencies, the current outbreak has been identified as the Bundibugyo strain of Ebola virus, a strain for which we are not aware of any approved treatment beyond supportive care as of the date of this release. Health officials continue to express concern about the possibility of cross-border transmission and widespread regional spread. Public health assessments, including potential cross-border transmission, are evolving and subject to change.\n <\/p>\n Athlon’s Hemopurifier is an investigational medical device designed to remove circulating viruses and tumor-derived EVs from the circulation. During the 2014 Ebola (Zaire strain) outbreak, a hemopurifier was successfully given to a critically ill Ugandan physician being treated at Frankfurt University Hospital under emergency use circumstances.\n <\/p>\n 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. After a single hemopurifier treatment of 6.5 hours, the patient’s viral load reportedly dropped from approximately 400,000 Ebola virus copies per milliliter of blood to about 1,000 copies per milliliter of blood. Ebola virus could not be detected five days after treatment. Testing after this treatment showed that the hemopurifier captured Ebola virus during treatment; The quantitative estimate reported at that time was approximately 242 million virions. The patient eventually recovered and returned home to Uganda.\n <\/p>\n That treatment data was presented by Helmut Geiger, MD, chief of nephrology at Goethe University, Frankfurt University Hospital, at the annual meeting of the American Society of Nephrology on November 14, 2014.\n <\/p>\n In the United States, hemopurifier therapy is already made available to Ebola patients through the FDA’s expanded-access emergency-use provisions, which apply in life-threatening situations where alternative treatments may not be available. In January 2015, the US Food and Drug Administration approved an investigational device exemption (“IDE”) supplement, which established a regulatory pathway for the potential investigational use of hemopurifier therapy in Ebola-infected individuals in the United States, subject to applicable institutional approval and patient safety procedures.\n <\/p>\n Investigational use of medical technologies such as hemopurifiers may proceed through physician-directed emergency and compassionate-use procedures subject to applicable hospital and regulatory oversight.\n <\/p>\n
<\/p>\n Athlon Medical Chief Executive Officer James B. “We believe the current Ebola outbreak reinforces the ongoing need for broad-spectrum therapeutic approaches capable of addressing viral threats where approved drug treatments or vaccines may be limited,” Frakes said. “While the hemopurifier remains investigational for Ebola treatment, preclinical experience on a patient in Germany has demonstrated the potential for rapid viral reduction in a critically ill patient under emergency use conditions.”\n <\/p>\n
\n <\/p><\/blockquote>\n The company said it would continue to monitor the evolving Ebola situation and respond to questions or requests from treating physicians.\n <\/p>\n About Hemopurifier(R)<\/strong><\/p>\n The Athlon Hemopurifier is an investigational medical device designed to remove circulating viruses and tumor-derived EVs from the circulation. It is used exogenously with a blood pump and combines plasma separation, size exclusion and affinity binding using plant lectin resins that target the mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and resistance to immunotherapy and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both in vitro studies and human subjects.\n <\/p>\n The Hemopurifier has a US Food and Drug Breakthrough Device designation for:\n <\/p>\n
\n Athlon Medical, Inc.<\/a>(Nasdaq: AEMD<\/a>), a medical therapeutics company focused on developing products to treat cancer and life-threatening infectious diseases.\n <\/p>\n