Medigus Ltd. (TASE:MDGS) yesterday announced that it has completed a multicenter study of its SRS endoscope for the treatment of Gastroesophageal reflux disease (GERD). The decision was made on the basis of seven successful additional procedures carried out with the SRS endoscope at Indiana University, the University of California San Diego (UCSD), and the University Medical Center of the Johannes Gutenberg University Mainz in Germany.
Medigus said that it is now preparing to conduct a statistical analysis of the results of these procedures, and that the results will be available six months after completion of the last procedure.
Medigus CEO Dr. Elazar Sonnenschein said, "After hard work over several years, I am pleased and proud to announce the end of the study and successful interim results obtained so far. Medigus will now begin the final stages of the US Food and Drug Administration (FDA) regulatory process for obtaining marketing approval for the SRS in the US."
Medigus also received interim results from UCSD and Indiana University on 29 procedures undertaken as part of the multicenter study. The results are based on at least three months monitoring following the procedures, out of the six-month monitoring period set out in the FDA study protocols. 80% of the patients met the primary end-points set by the protocols, 90% of the patients reported that they more than halved the use of Proton Pump Inhibitor (PPI) medications, and 50% reported that they ceased using the drugs altogether. The researchers are due to publish the results at the Digestive Disease Week conference in May 2011.
More than 500,000 surgical procedures for GERD are carried out globally each year, and the number is rising by 9% a year. The average price of the surgical procedure is $12,000. More than one million people take PPI medications, and 40% of patients do not respond well to the medication and require alternative treatments.
Medigus plans to play a role in the GERD surgery market within a few years. Its minimally invasive SRS endoscope is aimed to replace current invasive procedures, and will speed up patient recovery.
Medigus' share price rose 1.7% in morning trading to NIS 1.46, giving a market cap of NIS 108 million.
Published by Globes [online], Israel business news - www.globes-online.com - on December 15, 2010
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