Aethlon Medical, Inc., a medical device company, has submitted an investigational device exemption, or IDE, to the FDA that requests permission to initiate a clinical feasibility study of Hepatitis-C, or HCV, infected individuals enrolled to receive Hemopurifier therapy.
Upon approval by FDA, an IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application.
The Aethlon Hemopurifier is a first-in-class medical device that targets the rapid clearance of HCV from the entire circulatory system. The goal of therapy is to improve the benefit of interferon-based or all-antiviral HCV drug regimens.
Aethlon's IDE submission included clinical data from Hemopurifier studies of HCV-infected individuals conducted at the Apollo Hospital, Fortis Hospital, and the Medanta Medicity Institute, all located in India.
As requested by FDA during a Pre-IDE meeting, Aethlon also provided data that quantified the capture of HCV within the Hemopurifier during treatment. The proposed feasibility study would enroll 10 patients with End Stage Renal Disease (ESRD) and concomitant HCV infection.
The study would be conducted by the Renal Research Institute (RRI), which was established in 1997 as a partnership between Fresenius Medical Care (FMC) and Beth Israel Medical Center, New York City.