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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 was quite high, over 95%."

In this study, patients with the most advanced stages of Barrett's esophagus (dysplasia and early cancer) were first staged with endoscopic resection where a large tissue biopsy was obtained to confirm absence of deeply invasive cancer. The patient then received ablation using the HALO360 Ablation System, a balloon-based ablation device designed to remove the diseased cells using controlled heat. Procedures were performed non-surgically, using endoscopy and sedation, which allowed the patient to return to normal activity after the procedure. Patients then underwent focal ablation with the HALO90 Ablation System, a smaller device that mounts on the endoscope and is designed to treat small residual areas of Barrett's esophagus. Patients had endoscopy with biopsy to confirm elimination of the disease.

The study was conducted at three European centres, including the Academic Medical Centre, Amsterdam; Evangelisches Krankenhaus, Dusseldorf; and Erasme University Hospital, Brussels.

About the United European Gastroenterology Week (UEGW)

The UEGW is sponsored by the United European Gastroenterology Federation and is the venue where scientists and clinicians present and learn about the latest advances in the fields of gastroenterology, endoscopy, hepatology, and gastrointestinal surgery.

About BARRX Medical, Inc.

BARRX Medical, Inc. develops non-surgical, endoscopic treatment solutions for Barrett's esophagus. The company's HALO360 Ablation System uses a balloon-based electrode to ablate Barrett tissue circumferentially within the esophagus. The HALO90 Ablation System is an electrode system that is mounted on the end of an endoscope, allowing the physician to treat focal areas of diseased tissue. Both HALO Systems provides uniform and controlled therapy at a consistent depth to remove Barrett's esophagus and allow the regrowth of normal cells. Both systems are cleared by the U.S. Food and Drug Administration and have CE Mark in Europe. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is a privately held company. Additional information about BARRX Medical, Inc. and the HALO System is available at http://www.barrx.com.


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SOURCE BARRX Medical, Inc.
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