IDE Submitted Seeking Approval of U.S. Feasibility Study - Analyst Blog
03 Janvier 2013 - 11:59AM
Zacks
IDE Submitted Seeking Approval
of U.S. Feasibility Study
By Brian Marckx, CFA
This morning Aethlon Medical
(OTC BB:AEMD) 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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