HALO Ablation System Cures 96 Percent with Esophageal Cancer

May 15, 2007 - BARRX Medical, Inc. announced at Digestive Disease Week in Washington, D.C., results of a clinical trial in which 96 percent of patients with advanced stages of Barrett's esophagus, dysplasia and early cancer, who were treated with the HALO Ablation System, an endoscopic device which removes diseased tissue without the need for surgery, were cured of the disease, with average follow-up exceeding one year. Additionally, all genetic abnormalities associated with developing cancer of the esophagus were reportedly eliminated after treatment.
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.
“We have been successful in using the HALO Ablation System for the treatment of patients with dysplasia and early cancer of their esophagus,” said Jacques Bergman, M.D., associate professor, Department of Gastroenterology, Academic Medical Center, Amsterdam, the Netherlands, the senior investigator for this study. “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.”