IDE Submitted Seeking Approval of U.S. Feasibility Study
By Brian Marckx, CFA
This morning Aethlon Medical (OTC BB:) announced that they have submitted an Investigational Device Exemption (IDE) to the FDA seeking approval to commence a 10-patient safety and effectiveness feasibility study of Hemopurifier. We view this as a meaningful step towards AEMD's goal of bringing Hemopurifier to the U.S. market. The company notes that data from the recent and ongoing studies at hospitals in India were used to support the IDE submission and also included HCV capture data, the latter which that the FDA had requested at a pre-IDE meeting in 2011.
The proposed trial, which we expect would begin shortly following an approval by FDA of the IDE, would enroll 10 end stage renal disease patients infected with HCV and be conducted by the Renal Research Institute, a partnership between Fresenius Medical Care (FMS), a leader in dialysis products and services, and Beth Israel Medical Center in NYC.
Click here to view our most recent report on AEMD.
About Renal Research Institute*
Renal Research Institute (RRI) was established in 1997 as a partnership between Fresenius Medical Care (FMC) and Beth Israel Medical Center, New York City. It is an administratively distinct institution which collaborates with a select group of US based dialysis facilities with strong ties to academic research including the University of Michigan, the University of North Carolina, the University of Rochester, Yale University through St. Raphael Hospital in New Haven, CT and their dialysis facilities. RRI trains Research fellows from countries around the world in kidney disease-related clinical research. Its research spans a full spectrum of interests from molecular biology, clinical research, and pharmaceutical trials to epidemiology. The network of international collaborators has made it a global research institution with ties to Europe, Asia, Central and South America and Africa. The Institute is dedicated to improving the outcomes of patients with kidney disease requiring dialysis. RRI members participated in the NIH funded, NCDS, HEMO, CHOICE and FHN trials.
*SOURCE: Renal Research Institute
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