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Aethlon gets US FDA EAP designation to accelerate US access to Hemopurifier to treat life-threatening viruses

San Diego
Thursday, September 14, 2017, 16:00 Hrs  [IST]

Aethlon Medical, a therapeutic technology company focused on unmet needs in global health and biodefense, announced that it has received an Expedited Access Pathway (EAP) designation from the United States Food and Drug Administration (FDA) to support the advancement of the Aethlon Hemopurifier to treat life-threatening viruses. The FDA EAP programme was established to facilitate more rapid patient access to breakthrough technologies with the potential to address life threatening disease conditions for which no approved or cleared treatment alternatives exist.

"We are honored to have our Hemopurifier designated to the Expedited Access Pathway and additionally are pleased that FDA has also allowed our proposed "indication for use," which provides the possibility of treating a wide-range of life-threatening viruses versus a single disease condition," said Jim Joyce, Chairman and CEO of Aethlon Medical.

Aethlon proposed the following "indication for use" in its EAP submission; "The Hemopurifier is a single-use device indicated for the treatment of life-threatening highly glycosylated viruses that are not addressed with an approved treatment." To date, the Hemopurifier has been validated to capture a broad-spectrum of viruses that are highly glycosylated, including life-threatening strains of pandemic influenza viruses, mosquito-borne viruses as well as hemorrhagic viruses that are not addressed with an approved treatment.

The FDA established the EAP program for medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA's PMA approval standard of reasonable assurance of safety and effectiveness.

 

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