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On August, 28, 2008, Prof. Johannes Zacherl from the Medical University of Vienna, Austria, confirmed Medigus' Medical Director's report regarding positive results from additional human clinical trials that the company has performed with its SRS system for the treatment of gastroesophageal reflux disease (GERD).
On June 11-12, 2008, Prof. Zacherl performed clinical trials in 6 patients together with Prof. Sebastian Schoppmann.
The report shows that one month post procedure follow-up results are very encouraging.
According to the follow-up, all of the 6 patients who underwent the procedure are functioning well, are not suffering from any heartburn symptoms, and their satisfaction of the procedure is very high.
Moreover, right after the procedure, 5 of the patients have completely stopped taking any medications for heartburn, and the last patient stopped taking his medications approximately one month after procedure.
The aforementioned clinical trials are part of a human multi-center study that the company is currently conducting towards FDA 510(k) clearance for marketing the SRS system in the US.
[Non-binding translation of the company's Hebrew announcement.]
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