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Researchers Present Safety and Efficacy Results of 429 Patients Treated With Radiofrequency Ablation for Pre-Cancerous Barrett's Esophagus
Date:6/1/2009

tiary referral centers."

Study centers were comprised of large community practices with expertise in therapeutic endoscopy and the management of Barrett's esophagus. Radiofrequency ablation was applied with a balloon-based circumferential device and an endoscope mounted focal device. Patients underwent biopsy sampling of tissue from the esophagus at regular intervals to determine if all Barrett's disease had been eradicated. To be considered a "complete responder," all biopsy samples had to be normal.

"This study is highly relevant and represents an important contribution to the science related to Barrett's esophagus therapy," commented David S. Utley, M.D., chief medical officer for BARRX Medical. "The study's strengths lie in its large number of studied patients, relatively long follow-up and objective histology endpoints. This evidence suggests that ablative therapy can be delivered by the expert endoscopist in the community setting, with an expectation for comparable results as seen in prospective trials from tertiary referral centers."

About BARRX Medical, Inc.

BARRX Medical, Inc. develops treatment solutions for Barrett's esophagus, a precancerous condition of the lining of the esophagus (swallowing tube) caused by gastroesophageal reflux disease, or GERD. Its main product, the HALO360 System, provides a uniform and controlled ablation effect, which removes the diseased tissue and allows regrowth of normal cells. The HALO90 System is the company's second ablation product, which is mounted on the end of an endoscope and used to treat smaller, non-circumferential areas of disease.

A multi-center randomized, sham-controlled study, published in the New England Journal of Medicine, studied radiofrequency ablation applied in the highest risk Barrett's population (those having dysplasia). The ablation group had a high rate of complete eradication of dysplasia and
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SOURCE BARRX Medical, Inc.
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