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Investigators To Present Positive Clinical Trial Results Underscoring the Efficacy of BARRX Medical's Ablation Systems for Barrett's Esophagus; HALO360 System to Prove Favorable Impact on the Most Dangerous Grade of Barrett's Esophagus.

DALLAS -- BARRX Medical, Inc. today announced four clinical studies involving the HALO360 and HALO90 Systems, their endoscopic ablation systems for Barrett's esophagus, will be presented at the Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), April 26-29 in Dallas. The studies will validate the performance and efficacy of the HALO ablation systems for treating Barrett's esophagus, a precancerous condition caused by chronic acid reflux disease or GERD. Left untreated, Barrett's esophagus can lead to a dangerous form of cancer called esophageal adenocarcinoma, which is currently the fastest rising cancer in the United States.

C. Daniel Smith, M.D., Professor of Surgery, Emory University, Atlanta, Georgia will present the results of the study entitled, "Endoscopic Ablation of Intestinal Metaplasia with High-Grade Dysplasia in Esophagectomy Patients using a Balloon-based Ablation System," at the plenary session of SAGES. Patients with the most dangerous grade of Barrett's esophagus, high-grade dysplasia (HGD), were enrolled at four U.S. institutions. The current therapy for this diagnosis is esophagectomy, surgical removal of the esophagus. In this study, patients received ablation of the HGD using the HALO360 System, a balloon-based radiofrequency device which is designed to remove the diseased cells. The ablation treatment was immediately followed by esophagectomy. The investigators concluded that complete removal of HGD was possible using the HALO360 System. "This study, along with non-esophagectomy clinical trials currently underway, will identify the optimal treatment parameters for treating HGD in patients who otherwise would be subjected to surgical esophagectomy," says Dr. Smith.

Kenneth J. Chang, M.D., Associate Professor of Clinical Medicine, University of California, Irvine, California authored a study which will be presented at the Emerging Technology Session of SAGES, entitled "A Novel Endoscope-Mounted Focal Ablation Device for Barrett's Esophagus." Chang's surgical colleague, Ninh Nguyen, M.D., will present this study and will discuss how this device was able to ablate to a similar depth as the HALO360 System, yet afforded the physician the ability to smaller, non-circumferential areas of Barrett's esophagus. "The HALO90 device will significantly improve cure rates when ablating Barrett's esophagus, either in conjunction with HALO360 therapy or as a stand-alone treatment," says Chang. "Complete elimination of all Barrett's tissue in all patients is the ultimate goal of this therapy."

Brian J. Dunkin, M.D., Associate Professor of Surgery, University of Miami, Miami, Florida will present the results of a study entitled, "Determining the Inner Diameter of the Esophageal Body Using an Endoscopic Balloon Catheter, Pressure/Volume Monitoring and Automated Inflation System." The system tested in this study is the automatic sizing function integrated into the HALO360 System, which can measure the inner diameter of any tubular portion of the digestive tract.

Vic Velanovich, M.D., Division Head, General Surgery, Henry Ford Hospital, Detroit, Michigan will present the results of his study entitled, "Effect of Endoluminal Radiofrequency Ablation of Barrett's Esophagus on the Reflux Symptoms in Patients with Fundoplication." The results will demonstrate that ablation therapy does not disrupt the pre-existing fundoplication and that GERD symptoms do not increase after ablation.

Barrett's esophagus occurs when GERD causes the cells lining the esophagus to undergo genetic changes that can set the stage for cancer development. Barrett's has traditionally been managed with frequent endoscopic biopsy surveillance to detect progression to cancer. However, many physicians have long recognized the need to more proactively treat Barrett's esophagus as opposed to watching and waiting for cancer to develop. Ablation, the use of energy to remove the diseased layer of cells from the esophagus, offers treatment for the disease before it has the opportunity to progress to cancer. New healthy tissue replaces the ablated Barrett's tissue in three to four weeks for most patients.

About the HALO360 System

The BARRX Medical HALO360 System is the first of a new generation of ablation tools that provides uniform and controlled ablative therapy at a consistent depth to remove the layer of the diseased esophageal tissue allowing replacement by normal cells. The procedure, which in clinical studies had a median procedure time of 26 minutes, is performed without incisions using conscious sedation in an out-patient setting. First, a physician uses a HALO360 sizing balloon catheter to dilate the esophagus and determine its inner diameter. A correctly sized ablation catheter is then inflated within the diseased area of the esophagus. The HALO360 energy generator is activated to deliver a rapid (less than one second) burst of ablative energy, which removes a very thin (less than one millimeter) layer of the diseased esophagus. Controlled delivery of energy avoids injury to normal, healthy underlying tissues. New healthy tissue replaces the ablated Barrett's tissue in three to four weeks for most patients, according to trial results. Minor discomfort, which may be experienced by some patients, has been managed in the trials with medication. Following ablation therapy, patients resume acid suppression therapy.

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 regrowth of normal cells. In the largest study conducted (AIM-II Trial), 70 percent of patients were Barrett's-free (at one year follow-up). 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. Based in Sunnyvale, Calif., BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional information about BARRX Medical, Inc. and the HALO360 System is available at
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Publication:Business Wire
Date:Apr 26, 2006
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