Presentation of Landmark Clinical Trial Evaluating Endoscopic Treatment for Pre-cancerous Condition of...( Superiority of Ablation Therapy ...)

Superiority of Ablation Therapy Using HALO System Demonstrated for Eradicating Barrett's Esophagus and Reducing Risk for Disease Progression

SAN DIEGO, May 19 /PRNewswire/ -- Booth #2349 -- Digestive Disease Week -- BARRX Medical, Inc., a technology leader in the design and manufacture of medical devices for digestive diseases, today announced the presentation of a landmark study entitled, "A Randomized, Multicenter, Sham-Controlled Trial of Radiofrequency Ablation (RFA) for Subjects with Barrett's Esophagus (BE) Containing Dysplasia: Interim Results of the AIM Dysplasia Trial." The study was presented by Nicholas J. Shaheen, M.D., Associate Professor of Medicine and Epidemiology, The University of North Carolina, during the clinical plenary session of the American Gastroenterological Association at the Digestive Disease Week meeting in San Diego, California.

"This is a very well-designed trial conducted in a rigorous manner at 19 expert U.S. centers, each having experience in the management of Barrett's esophagus and dysplasia," said Dr. Shaheen. "Our interim results are highly promising, demonstrating superiority for ablation therapy for eliminating Barrett's and dysplasia, as well as reducing the risk for disease progression. Although we continue to complete the trial, these results may ultimately change the paradigm for how gastroenterologists manage their patients with Barrett's esophagus."

Beginning in 2006, the AIM Dysplasia Trial enrolled 127 patients with a diagnosis of dysplastic Barrett's esophagus, the most advanced stage of this precancerous condition. As a result of injury from gastroesophageal reflux disease or GERD, the normal esophageal lining is replaced with abnormal cells (Barrett's tissue), predisposing the patient to a higher risk for developing cancer of the esophagus. Patients with Barrett's who develop cancer, typically do so through a series of steps, starting with Barrett's, then Barrett's with low-grade dyspl
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