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Surgical Endoscopy Publishes Data Evaluating Dosing and Ablation Depth of the HALO360 System in the Human Esophagus: A Technology Relevant As a Current Treatment for Barrett's Esophagus

Posted on: Friday, 20 January 2006, 09:00 CST

BARRX Medical, Inc. today announced the publication of a study titled "Thin Layer Ablation of Human Esophageal Epithelium Using a Bipolar Radiofrequency Balloon Device" evaluating the dose-response and ablation depth effect of the HALO360 System in the human esophagus. The study appears in the January issue of Surgical Endoscopy, the official journal of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

Thirteen male patients aged 49-85, all diagnosed with esophageal adenocarcinoma, were enrolled in this study intended to determine the optimal energy density and treatment parameters to achieve the complete removal of human esophageal epithelium. The study was designed as a pilot trial leading up to the use of this device in patients with Barrett's esophagus, a premalignant disease of the esophageal epithelium.

The study patients underwent randomization into three groups, with each group receiving slightly different energy doses when treated with the HALO360 System. Endoscopy was performed, followed by positioning of the HALO360 ablation catheter within the esophagus. The ablation catheter was inflated and a short burst of heat energy was delivered to the thin epithelial lining of the esophagus. This was followed by a total esophagectomy (removal of the esophagus) as indicated by the cancer diagnosis. Pathological evaluation was performed on the ablated segments to determine the ablation depth and completeness of epithelial removal.

The study results confirm that the HALO360 System is capable of removing the esophageal epithelium without causing untoward injury to the delicate underlying structures. These data have been used to identify the appropriate treatment parameters for the use of the HALO360 System in subsequent clinical trials for patients with the diagnosis of Barrett's esophagus, who have not yet progressed to esophageal cancer.

"Barrett's esophagus is a pre-cancerous entity, much like a polyp in a patient's colon," said Brian J. Dunkin, M.D., Associate Professor of Surgery and Chief of the Division of Laparoendoscopic Surgery at the University of Miami Miller School of Medicine. "We currently do not have a reliable proactive therapy for Barrett's esophagus but are encouraged by the results of this study as it provides valuable information for physicians regarding the treatment settings necessary to completely and safely remove esophageal epithelium in human patients."

Barrett's esophagus is a premalignant change in the esophageal lining, affecting approximately 3.3 million U.S. adults. Barrett's esophagus occurs when chronic acid exposure causes the cells lining the esophagus to break down and undergo genetic changes that can set the stage for cancer. The most common approach to managing Barrett's today is regular surveillance, which involves watching the disease and monitoring its progression, along with drug therapy to control GERD symptoms. With the HALO360 system, physicians can destroy the Barrett's tissue before it has a chance to develop into cancer just as they would any other precancerous condition found in the body. The ability to safely and effectively remove Barrett's esophagus may help ease patient anxiety about living with a precancerous condition and possibly reduce the number of patients who go on to develop esophageal adenocarcinoma.

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 www.barrx.com.

Source: Business Wire

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