Aethlon Medical (OTC:AEMD) said that it plans to make its Hemopurifier blood-filtration device available to U.S. healthcare providers for the treatment of Ebola under the FDA’s compassionate use provision.
"Based on guidance from FDA, the treatment of Ebola virus infection provides for a unique circumstance where a physician or healthcare provider may wish to pursue the compassionate use of Hemopurifier therapy based on the serious nature of the disease and absence of alternative therapies," according to a press release.
"Compassionate use provisions are typically approved by FDA on an individual patient basis, but may be expanded to include a small group," Aethlon added.
In mid-October, Aethlon revealed Hemopurifier was being used to treat an Ebola patient hospitalized in Frankfurt, Germany. Aethlon is planning to submit treatment data to the FDA in hopes of expanding use of the device under the agency’s emergency use provision.
“The administration of Hemopurifier therapy in Germany has reinforced the need to clarify defined regulatory pathways that might allow us to treat Ebola infection in the United States," founder & CEO Jim Joyce said in a statement. "As it relates to the patient treated in Germany, we respect patient confidentiality and will report on his response to therapy after Frankfurt University Hospital officials provide an update on his condition."
Aethlon added that it plans to initiate U.S. clinical testing of the device under a previously filed investigational device exemption. Last year, the FDA approved IDE testing of the product for the treatment of hepatitis C.
Laboratory studies have shown Hemopurifier can be effective in filtering such dangerous viral pathogens as Ebola, Dengue, avian flu and West Nile, Aethlon said.
