HALO Ablation System cures 96% of patients with dangerous esophagus

condition

    SUNNYVALE, Calif., May 15 /PRNewswire/ -- 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, Inc.