AEMD's Positive Recent Developments
We have updated our 20-page report on Aethlon Medical (OTC BB:AEMD) for several recent developments. See below for access to our full report on the company.
Hemopurifier Status Update
AEMD appears to be close to getting an answer from FDA on their application for Investigational Device Exemption (IDE). As a reminder, in early January 2013 AEMD announced that they submitted an IDE to the FDA seeking approval to commence a 10-patient safety and effectiveness feasibility study of Hemopurifier. Included in the submission was data from the recent and ongoing studies at hospitals in India as well as HCV capture data, the latter which that the FDA had requested at a pre-IDE meeting in 2011. Then in late-March, following response from FDA which included comments and study design considerations, AEMD resubmitted the IDE.
FDA has since communicated that they are withholding clearance of the IDE until AEMD addresses the agency's safety concern, namely that the company detail their training and monitoring procedures for heparinization - the anticoagulant used during dialysis and with the Hemopurifier. AEMD noted in early May that they were gathering the requested information and expected to have it submitted to FDA in the coming week (i.e. - by mid-May). This will hopefully be the final step and initiation of the U.S. study will be forthcoming.
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