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news.Aethlon Medical, a medical device company, has entered into a non-exclusive agreement with Bioserv doing business as NextPharma Technologies, to establish manufacturing of the Aethlon Hemopurifier under good manufacturing practice requirements set forth in quality system regulations for medical device commercialization.
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According to Aethlon, the Hemopurifier is a medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins from the entire circulatory system.
Safety of the Hemopurifier has been demonstrated in multi-site human studies, with robust viral load reductions observed in enrolled Hepatitis-C infected patients. In addition to establishing good manufacturing practice (GMP), market clearance of the Hemopurifier will be required by the FDA prior to mainstream commercialization in the US.
Jim Joyce, chairman and CEO of Aethlon, said: “While GMP may not be required for clinical studies, it will position us to export our Hemopurifier for sale as demand becomes established in India and other practitioner driven markets. Additionally, the manufacturing of our Hemopurifier under GMP improves our readiness to respond to emergency and humanitarian use requests, including the sudden emergence of bioterror and pandemic threats.”