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New Study Reports That Ablative Therapy With HALO360 Device Effectively Treats Highest-Risk Category of Barrett's Esophagus
Date:5/15/2008

Highest-risk precancerous condition of esophagus eliminated in 90 percent

of patients

SUNNYVALE, Calif., May 15 /PRNewswire/ -- BARRX Medical, Inc., the global technology leader for treating precancerous conditions of the digestive tract, today announced that 90.2 percent of the patients in a multi-center U.S. study were free of the highest-risk of Barrett's esophagus after having a non-surgical, endoscopic treatment using the HALO360 ablation system. Barrett's esophagus afflicts more than three million U.S. adults and is a complication of gastroesophageal reflux disease (GERD). The abnormal Barrett's tissue is the precursor to esophageal cancer (adenocarcinoma), which has the fastest rising incidence of all cancers in the U.S.

This study is currently online and appearing in an upcoming issue of Gastrointestinal Endoscopy, a medical journal for gastroenterologists who perform advanced diagnostic and therapeutic endoscopic procedures. In the report titled, "Circumferential Ablation of Barrett's Esophagus Containing High-Grade Dysplasia: A U.S. Multi-Center Registry," 142 patients with the most advanced stage of Barrett's esophagus -- called high grade dysplasia -- were treated with the HALO360 Ablation System and had a 90.2% clearance rate. This unique, catheter-based technology applies a controlled amount of heat energy to the diseased tissue of the esophagus, resulting in restoration of a normal esophageal lining in the majority of patients.

"The results of our trial confirm that this sub-type of Barrett's esophagus having the highest-risk of becoming cancer can be safely and effectively treated," said Abbott Northwestern Chief of Gastroenterology and Associate Professor of Medicine, Robert Ganz, M.D., of Minneapolis, MN. Dr. Ganz led the study which was co-authored with specialists at 15 other leading U.S. medical centers. "We're confident this treatment can sharply reduce the number of patients who have an esophagectomy, which has historically represented the standard of care for patients with high grade dysplasia." An esophagectomy is surgical removal of the entire esophagus.

This study was conducted prior to availability of the HALO90 Ablation System, an adjunctive device that is utilized to treat small areas of residual disease after the initial therapy. In the largest study conducted with these devices working together, 98.4 percent of patients had complete elimination of all Barrett's tissue at 2.5 years of follow-up from initial therapy.

Recent studies have shown a significant further increase in response to therapy when combining the HALO360 and HALO90 modalities in a step-wise manner.

About the HALO Ablation System

The HALO System consists of the HALO360 Ablation Catheter which can treat precancerous Barrett's tissue in a 360 degree circumference, and the HALO90 Ablation Catheter which can be used to treat small areas of Barrett's tissue.

Both devices provide uniform and controlled heat therapy which remove the thin layer of diseased tissue and allow the regrowth of normal cells without undue injury to normal underlying tissue.

Treatment is performed without incisions using an endoscopic approach with the patient under conscious sedation. Most procedures are performed in an out-patient setting. Since HALO360 received FDA clearance in 2005 and HALO90 received clearance in 2006, more than 220 U.S. hospitals have incorporated the use of this device.

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.


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SOURCE BARRX Medical, Inc.
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