Aethlon Medical wins FDA EAP designation for Hemopurifier

Aethlon Medical (NSDQ:AEMD) said today it received an Expedited Access Pathway designation for its Aethlon Hemopurifier designed for treating life-threatening viruses. The San Diego-based company said its Hemopurifier has been validated to capture a “broad spectrum of viruses that are highly glycosylated”, which includes lethal strains of pandemic influenza, mosquito-borne viruses and hemorrhagic viruses with no currently approved treatment. “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,” CEO & chair Jim Joyce said in a prepared statement. Aethlon submitted its application for EAP designation in June after having finished its FDA-approved feasibility trial for the device in March. The feasibility study demonstrated that the Hemopurifier was well tolerated with patients with end-stage renal disease who were also infected with Hepatitis C. There were also no device-related adverse events, according to Aethlon. The post Aethlon Medical wins FDA EAP designation for Hemopurifier appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Aethlon Medical Inc. Source Type: news