SUNNYVALE, Calif., May 15 BARRX Medical, Inc., the globaltechnology leader for treating precancerous conditions of the digestive tract,today announced that 90.2 percent of the patients in a multi-center U.S. studywere free of the highest-risk of Barrett's esophagus after having anon-surgical, endoscopic treatment using the HALO360 ablation system.Barrett's esophagus afflicts more than three million U.S. adults and is acomplication of gastroesophageal reflux disease (GERD). The abnormal Barrett'stissue is the precursor to esophageal cancer (adenocarcinoma), which has thefastest rising incidence of all cancers in the U.S.
This study is currently online and appearing in an upcoming issue ofGastrointestinal Endoscopy, a medical journal for gastroenterologists whoperform advanced diagnostic and therapeutic endoscopic procedures. In thereport titled, "Circumferential Ablation of Barrett's Esophagus ContainingHigh-Grade Dysplasia: A U.S. Multi-Center Registry," 142 patients with themost 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 heatenergy to the diseased tissue of the esophagus, resulting in restoration of anormal esophageal lining in the majority of patients.
"The results of our trial confirm that this sub-type of Barrett'sesophagus having the highest-risk of becoming cancer can be safely andeffectively treated," said Abbott Northwestern Chief of Gastroenterology andAssociate Professor of Medicine, Robert Ganz, M.D., of Minneapolis, MN. Dr.Ganz led the study which was co-authored with specialists at 15 other leadingU.S. medical centers. "We're confident this treatment can sharply reduce thenumber of patients who have an esophagectomy, which has historicallyrepresented the standard of care for patients with high grade dysplasia." Anesophagectomy is surgical removal of the entire esophagus.
This study was conducted prior to availability of the HALO90 AblationSystem, an adjunctive device that is utilized to treat small areas of residualdisease after the initial therapy. In the largest study conducted with thesedevices working together, 98.4 percent of patients had complete elimination ofall Barrett's tissue at 2.5 years of follow-up from initial therapy.
Recent studies have shown a significant further increase in response totherapy when combining the HALO360 and HALO90 modalities in a step-wisemanner.
About the HALO Ablation System
The HALO System consists of the HALO360 Ablation Catheter which can treatprecancerous Barrett's tissue in a 360 degree circumference, and the HALO90Ablation Catheter which can be used to treat small areas of Barrett's tissue.
Both devices provide uniform and controlled heat therapy which remove thethin layer of diseased tissue and allow the regrowth of normal cells withoutundue injury to normal underlying tissue.
Treatment is performed without incisions using an endoscopic approach withthe patient under conscious sedation. Most procedures are performed in anout-patient setting. Since HALO360 received FDA clearance in 2005 and HALO90received clearance in 2006, more than 220 U.S. hospitals have incorporated theuse 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, theHALO360 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 wereBarrett's-free after two and a half years. The system used in the clinicaltrials was cleared by