Healthcare Industry News:  HALO90 

Devices Gastroenterology

 News Release - May 20, 2007

Presentation of Long-term Results for Treating Barrett's Esophagus with HALO Ablation System

Barrett's Esophagus Eliminated in 98.4% of Patients in Longest-Term Study to Date

SUNNYVALE, Calif., May 20 (HSMN NewsFeed) -- BARRX Medical, Inc. today announced that 98.4% of patients with Barrett's esophagus treated with the HALO Ablation System have no residual Barrett's esophagus tissue after a follow up period of more than two and a half years. The presentation of these long-term clinical trial results was made at the Digestive Disease Week (DDW) meeting this week, an international meeting of more than 16,000 gastrointestinal physicians and researchers, held in Washington D.C. Barrett's esophagus is a pre-malignant condition of the esophagus resulting from chronic gastroesophageal reflux disease or GERD.

One prominently featured scientific presentation was the long-term follow- up of the "Ablation of Intestinal Metaplasia" clinical trial. Patients with Barrett's esophagus underwent treatment with the HALO360 device, a balloon- based ablation catheter which removes diseased cells with controlled heat. After one year, any residual disease was further treated with the HALO90 device, an endoscope-mounted device that removes diseased cells with focal application of heat. Multiple tissue samples, or biopsies, were performed to assess the response to treatment and, at two and one half years follow-up, 98.4% of patients had no remaining Barrett's disease.

David E. Fleischer, M.D., Professor of Medicine, Mayo Clinic in Arizona, is the first author on this study. "That we can safely and completely remove all of the diseased Barrett's tissue from a patient's esophagus using this ablative technology is a very important advance for gastrointestinal medicine," says Dr. Fleischer. "Our results suggest that we can proactively eliminate Barrett's esophagus at the very earliest stage, rather than simply observing for progression over time. Physicians working with this exciting new technology will need to study how this treatment can best be applied and for what group of patients. The appeal of the HALO treatment is that we can simultaneously prevent cancer and reduce patient anxiety caused by their having to live with a premalignant condition."

Barrett's esophagus affects about 3 million U.S. adults and is related to the chronic injury to the esophagus from GERD. This disorder predisposes the patient to the development of esophagus cancer, which has demonstrated the fastest rise in new cases per year of all human cancers. Once Barrett's progresses to more advanced stages of the disease or to cancer, the standard therapy has been to surgically remove the esophagus.

Several other important studies were presented this week at the DDW meeting, including the use of the HALO system to treat patients with advanced stages of Barrett's esophagus such as dysplasia and early cancer. Investigators reported cure rates for dysplastic Barrett's esophagus of 90% or more after at least one year of follow-up. One study showed that ablation using the HALO system eliminated the genetic abnormalities that predispose a patient to developing cancer in the future. Another study reported that ablating one form of dysplasia (low-grade dysplasia) was more cost-effective than an observational strategy (endoscopy with biopsy to watch for disease progression). Results from a U.S. Registry study of 508 patients showed that a newer ablation tool, HALO90 ablation catheter, is safe for treating patients with focal areas of Barrett's esophagus.

"At this year's Digestive Disease Week meeting, physician investigators presented results from 13 different clinical trials assessing the performance of the HALO ablation technology for Barrett's esophagus," said David S. Utley, M.D., Chief Medical Officer, BARRX Medical, Inc. "This growing body of evidence shows that Barrett's esophagus and the associated genetic abnormalities can be safely and completely eliminated. If we could prevent just one patient from developing a devastating esophageal cancer, it is a great service for 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 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, 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 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

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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