The firm will seek FDA approval for its GERD treatment.
Medigus Ltd. (TASE:MDGS) will apply to the US Food and Drug Administration (FDA) under the 510K abbreviated regulatory procedure for marketing approval for the company's SRS esophageal endoscope for the treatment of gastroesophageal reflux disease (GERD). The application is based on favorable results on a clinical trial in India.
The trial included 13 patients in three groups at the Deenanath Mangeshkar Hospital and Research Center. The patients were monitored for six months. The primary measurements of results were recommended by the FDA on the basis of Health-Related Quality of Life (HRQL) measures.
Medigus's SRS is designed to replace invasive laparoscopic surgical procedures currently used to treat GERD.
Medigus soared over 40% by midday on the TASE following the results.
Published by Globes [online], Israel business news - www.globes-online.com - on December 26, 2007
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