Medigus looks to FDA approval

The company reports positive results in trials of its GERD treatment.

Medigus Ltd. (TASE:MDGS) yesterday reported good results in the clinical trial of its SRS endoscope for the treatment of Gastro-esophageal Reflux Disease (GERD). The company says that, while statistical analysis of the results is still incomplete, the results were positive and will likely enable the company to meet US Food and Drug Administration (FDA) requirements for approving the endoscope for marketing.

Medigus CEO Dr. Elazar Sonnenschein expects to receive the FDA's answer in the fourth quarter of this year or in the first quarter of 2012.

Medigus already sells the SRS endoscope in Europe, and has signed two agreements with minimum amounts of several hundred thousand dollars. The company expects to sign two or three similar agreements next year.

"It took ten years to develop the device," Sonnenschein told "Globes". "We won't develop another product that costs so much and takes so long. In recent years, the medical device industry has changed before our eyes, and the threshold has risen wherever you look - regulation, marketing, insurance indemnification, production. From now on, we will focus on products that cost no more than $2 million."

In the coming years, Medigus hopes to complete the licensing for two other independent products. The SRS endoscope is the company's leading product, but its business plan for the coming years is based on additional products. "It's hard to know which fields will yield the largest income in 2012," says Sonnenschein.

In 2012, Medigus also expects revenue from the miniature cameras that it is developing with Tower Semiconductor Ltd. (Nasdaq: TSEM; TASE: TSEM). The cameras are already being sold through three long-term agreements to medical devices companies.

Medigus's share price rose 4% in early trading today to NIS 0.98, giving a market cap of NIS 70 million.

Published by Globes [online], Israel business news - - on July 11, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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