Healthcare Industry News:  esophageal cancer 

Devices Gastroenterology

 News Release - May 15, 2007

Genetic Abnormalities Associated With Esophageal Cancer Eliminated After Treatment With HALO Ablation System

HALO Ablation System cures 96% of patients with dangerous esophagus condition

SUNNYVALE, Calif., May 15 (HSMN NewsFeed) -- BARRX Medical, Inc. today announced clinical trial results to be presented at Digestive Disease Week in Washington, DC, May 19-24, 2007. In one of the studies, patients with the most advanced stages of Barrett's esophagus, dysplasia and early cancer, were treated with the HALO Ablation System, an endoscopic device which removes diseased tissue without the need for surgery. After treatment, 96% of patients were cured of the disease, with average follow-up exceeding one year. Most importantly, all genetic abnormalities associated with developing cancer of the esophagus were eliminated after treatment.

Barrett's esophagus affects at least three million U.S. 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). 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 Center, Amsterdam, the Netherlands, was the senior investigator for this study. "We have been successful in using the HALO Ablation System for the treatment of patients with dysplasia and early cancer of their esophagus," says Dr. Bergman. "Until now, the patient with advanced stages of Barrett's esophagus would receive an esophagectomy or various endoscopic therapies, which are often associated safety risks. The results of this study suggest that not only can we safely and completely remove the diseased esophageal tissue, but we can also eliminate all the genetic abnormalities associated with developing esophageal cancer in the future."

In this study, patients with the most advanced stages of Barrett's esophagus (dysplasia and early cancer) 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, as well as genetic testing of the new healed tissue to determine if genetic abnormalities had been eliminated.

"The results of this important study demonstrate that the HALO Ablation System can avoid the need for surgical removal of the esophagus by eliminating dysplasia and early cancer," said David S. Utley, M.D., Chief Medical Officer, BARRX Medical, Inc. "Dr. Bergman and his group have also shown that they can eliminate the genetic abnormalities that have accumulated in the esophageal cells over time, due to acid reflux and esophageal injury. By returning the

esophagus to its original healthy state, we believe that this may reduce or even eliminate the risk for cancer development in these patients."

About BARRX Medical, Inc.

BARRX Medical, Inc. develops treatment solutions for Barrett's esophagus. Its first product, the HALO360 Ablation System, uses a balloon-based electrode to ablate Barrett's tissue circumferentially within the esophagus. A newer product from BARRX Medical, the HALO90 Ablation System, is an electrode 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, which can remove Barrett's esophagus and allow the regrowth of normal cells. Both systems are cleared by the U.S. Food and Drug Administration, have the CE Mark for Europe, and are commercially available. Based in Sunnyvale, Calif., BARRX Medical, Inc. is a privately held company. Additional information about BARRX Medical, Inc. and the HALO Ablation Systems is available at http://www.barrx.com.

About Digestive Disease Week

Digestive Disease Week is considered the largest and most prestigious meeting in the world for the gastroenterology professional. Every year it attracts more than 16,000 physicians, researchers and academics from around the world who desire to stay up-to-date in their respective fields. The meeting is the year's best opportunity to learn about the latest advances in gastroenterology, hepatology, endoscopy and gastrointestinal surgery; prevention, diagnosis and treatment of digestive disorders; and cutting-edge technological advances.


Source: BARRX Medical

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