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Multi-Centre European Clinical Trial Shows Advanced Dysplasia and Early Cancer of Esophagus Cured With Combined Endoscopic Resection and Radiofrequency Ablation With HALO Ablation System
Date:10/19/2008

Non-surgical intervention cures 96% of patients with advanced esophagus

condition

SUNNYVALE, Calif., Oct. 19 /PRNewswire/ -- BARRX Medical, Inc. today announced clinical trial results presented at the United European Gastroenterology Week (UEGW) in Vienna, Austria, October 18-22, 2008. In a plenary presentation entitled, "Stepwise circumferential and focal radiofrequency energy ablation of Barrett's esophagus with early neoplasia: First European Multi-centre trial" patients with the most advanced stages of Barrett's esophagus, dysplasia and early cancer, were staged with endoscopic mucosal resection and then treated with the endoscopic radiofrequency ablation using the HALO Ablation System. After treatment, 96% of patients were cured of all diseased tissue, with average follow-up exceeding one year.

Population-based studies estimate that Barrett's esophagus affects approximately six million European and US adults and is a complication of a disorder called gastroesophageal reflux disease or GERD. Once diagnosed, Barrett's can worsen over time, developing dysplasia and esophageal adenocarcinoma (cancer), as in this study. Once dysplasia or cancer occurs, an esophagectomy (surgical removal of the entire esophagus) has been the first-line therapy. Esophageal cancer of this type is the fastest growing cancer in industrialized countries.

Jacques Bergman, M.D., Associate Professor, Department of Gastroenterology, Academic Medical Centre, Amsterdam, the Netherlands, was the senior investigator for this study. "In several back to back studies now, we have been successful in using the HALO Ablation System in conjunction with endoscopic resection to cure patients with advanced dysplasia or early cancer of the esophagus," says Dr. Bergman. "Until now, these patients would receive an esophagectomy or more invasive endoscopic therapies, which often have associated safety risks. In this study, the complete response rate
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SOURCE BARRX Medical, Inc.
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