Medigus Ltd. (TASE:MDGS) has completed all procedures mandated by the European and Canadian health authorities for obtaining CE Mark certification to market the company’s SRS System treatment device for Gastroesophageal Reflux Disease (GERD).
The CE Mark is a manufacturer’s declaration that the product meets the relevant criteria and technical specifications of the relevant authorities, but it does not necessarily constitute confirmation by the European authorities that the product is effective. Medigus has already obtained similar approval for certain components of its SRS System; the current CE Mark is for the complete system.
Medigus intends to defer marketing of the SRS System in Europe and Canada until it obtains updated data from upcoming clinical trials it plans to undertake in Australia, Austria, and the US. If favorable, the results of these tests will help the company market the product and obtain insurance coverage for it.
Medigus has a market cap of NIS 180 million. The company held its IPO on the Tel Aviv Stock Exchange (TASE) in March at a value of NIS 84 million, after money. The company’s SRS System for treating GERD is a flexible endoscope guided by ultrasound and a camera. At the tip of the device is a stapler that staples stomach tissue surrounding the esophagus, thereby preventing reflux. This stapling is normally done by a surgical procedure, which Medigus wants to replace with a non-invasive procedure. This is the device that has now obtained CE Mark certification, and the company believes that it will obtain the stricter US Food and Drug Administration (FDA) certification in early 2007.
Published by Globes [online], Israel business news - www.globes.co.il - on June 5, 2006
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