Endoscopic ablative therapy with HALO device leads to 100% patient response
SUNNYVALE, Calif., May 20 /PRNewswire/ -- BARRX Medical, Inc., a global technology leader in treating Barrett's esophagus, today announced the publication of two related European trials which report a 100% eradication rate for early esophageal cancer and pre-cancerous dysplasia using endoscopic resection followed by ablation therapy with the HALO ablation system. Barrett's esophagus is a complication of gastroesophageal reflux disease (GERD) and is a known risk factor for esophageal cancer, the fastest growing cancer in the Western world.
Results of the two studies were published in the May issue of Endoscopy, a medical journal for gastroenterologists performing advanced endoscopic procedures. They were titled "Effective treatment of early Barrett's neoplasia with stepwise circumferential and focal ablation using the HALO system," and "Stepwise circumferential and focal ablation of Barrett's esophagus with high- grade dysplasia: results of the first prospective series of 11 patients." The investigators enrolled patients with Barrett's esophagus having early cancer and/or advanced dysplasia, used endoscopic resection to remove focal abnormal areas, then used endoscopic ablative therapy with the HALO system to eradicate all remaining diseased tissue. At one and two year follow-up, respectively, in each trial, all patients were cured of their esophageal disease.
"This data confirms that early cancer and advanced dysplasia can be safely and effectively treated with this non-surgical approach using endoscopic resection and ablation," said Amsterdam Medical Centre (AMC) gastroenterologist and Professor of Medicine Jacques Bergman, M.D., who led the study in Amsterdam, the Netherlands. "We're confident this treatment can reduce the need for high risk surgical procedures and become the preferred strategy for treating patients with Barrett's esophagus and early esophageal cancer."
A related study presented last year in May 2007 at an international gastroenterology meeting reported that ablative therapy, as used in this trial, eradicated all the associated genetic abnormalities of the early cancer and dysplasia in treated patients.
A current standard of treatment for advanced dysplasia and early cancer of the esophagus is surgical removal of the esophagus (i.e. esophagectomy.) This surgical procedure is often associated with significant patient morbidity and even mortality. Once cancer occurs, the five year survival is poor. According to the American Cancer Society, 16,470 new diagnoses and 14,280 deaths due to esophageal cancer will occur this year in the U.S.
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 flagship product, the HALO360 System, provides uniform and controlled therapy at a consistent depth, which can remove Barrett's esophagus and allow the re-growth of normal cells. In the largest study conducted (AIM-II Trial), 98 percent of patients were Barrett's-free after two and a half years. The system used in the clinical trials was cleared by the U.S. Food and Drug Administration in 2001 and has been commercially available since January 2005. Over 14,000 procedures have been performed in over 200 hospitals around the world. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional information about BARRX Medical, Inc. and the HALO ablation system of products is available at http://www.barrx.com.
Endoscopy, the official publication for the European Society of Gastrointestinal Endoscopy (ESGE), publishes original, peer-reviewed articles on endoscopic procedures used in the study, diagnosis, and treatment of digestive diseases. Over the past decades, it has become one of the world's leading journals in GI endoscopy. Founded by Professor Ludwig Demling in 1961, Endoscopy has grown in prestige and quality. This development has been enhanced by the close ties which have been established with individual national endoscopic societies.
To date, twenty societies are affiliated to Endoscopy.
|SOURCE BARRX Medical, Inc.|
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