Medigus

16-03-2008

Medigus hereby announces that it has received an immediate approval from The US Food and Drug Administration (FDA) to perform a multi-center human clinical study in the US (IDE – Investigational Device Exemption), using an endoscope and the company’s SRS system for treatment of Gastro Esophageal Reflux Disease (GERD).

According to the FDA approval, the company may immediately initiate the clinical study in the US. In parallel, the company was requested to complete various details in its documents submitted to the FDA.

Following receipt of the FDA approval, the company intends to initiate the clinical study as part of the process of approval of the SRS system for marketing in the US, via the short regulatory process (the 510k process).

[Non-binding translation of the company's Hebrew announcement.]

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