Medigus

The trials were conducted in the Deenanath Mangeshkar Hospital and Research Center in India.

The SRS system developed by the company is designed to replace the invasive surgery (laparoscopic), which is currently accepted as the common procedure for treatment of GERD.

The clinical results were obtained from the medical center after a 6 months follow up of 4 patients who took part in the trial during April, 2007, a 3 months follow up of 4 patients who took part in the trial during August, 2007, and a 6 weeks follow up of 5 patients who took part in the trial during October 2007 (a total of 13 patients).

The follow up results were summarized in a detailed report prepared by Dr. Aviel Shapira, Medical Director of the company, who took part in all the above trials performed in the medical center. The report describes the medical tests and assessments performed during the follow up period and summarizes the findings.

The report compares the results obtained in clinical trials with the SRS system of Medigus with those achieved by the standard surgery in GERD treatment, based on the medical literature.

According to the report, there are several endpoints for evaluating the results of GERD treatment by the standard surgery. The primary endpoint analysis recommended by the FDA for evaluating the results of GERD treatment is based on HRQL (Health Related Quality of Life - a scale of 10 disease related quality of life parameters). Secondary endpoints for evaluating the results of GERD treatment include consumption of PPI drugs (Proton Pump Inhibitor – drugs for treatment of chronic heartburn), duration of esophageal acid exposure and the major adverse event – dysphagia (difficulty swallowing).

According to the report, the clinical results achieved by the SRS system of Medigus in the above 13 patients were similar to those known to be obtained by the standard surgery commonly used in GERD treatment.

The primary endpoint analysis of all the 13 patients demonstrated a significant improvement, indicating a 100% success with respect to this endpoint.

In addition, the secondary endpoint analysis demonstrated 92% improvement in the PPI consumption endpoint (as compared to 91% improvement achieved by the standard surgery), and a statistically significant reduction in the duration of esophageal acid exposure. Furthermore, none of the patients experienced the adverse event of dysphagia after treatment by the SRS system (as compared to about 15%-25% of patients experiencing dysphagia after treatment by the standard surgery).

Finally, Dr. Shapira concludes that although the follow up study included a relatively small number of patients treated by the Medigus procedure (13 patients), the results of 6 week, 3 month and 6 month follow up studies are sustained over prolonged time periods. Thus, we may conclude that the primary endpoint results obtained in these trials are at least as good as those achieved by the standard surgery, and that part of the secondary endpoint results are similar to those observed after the standard surgery.