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BARRX Medical, Inc. Introduces New Minimally Invasive Tool for Treating Barrett's Esophagus

Posted on: Monday, 6 March 2006, 12:00 CST

BARRX Medical, Inc. today introduced the HALO360 System, a new, minimally invasive tool for the treatment of Barrett's esophagus, a precancerous condition of the esophagus caused by GERD (gastroesophageal reflux disease). Left untreated, Barrett's esophagus, which affects approximately three million U.S. adults, can lead to esophageal adenocarcinoma, the fastest rising cancer in the U.S. The HALO360 System is the first circumferential ablative tool that utilizes radiofrequency (RF) ablation therapy to remove the Barrett's esophagus tissue before it progresses to cancer. The HALO360 System was designed, in part, to reduce the risk of complications that have been associated with other forms of ablation therapy.

Barrett's esophagus occurs when chronic exposure to acid from the stomach 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 esophagus today is surveillance, which involves regular endoscopic procedures and tissue sampling, monitoring for disease progression, along with drug therapy to control GERD symptoms and prevent acid-related injury to the esophagus. With the HALO360 System, physicians can remove 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 reduce the need for life-long endoscopic surveillance, ease patient anxiety about living with a precancerous condition, and possibly reduce the number of patients who go on to develop esophageal adenocarcinoma.

The HALO360 System enables the delivery of controlled circumferential ablative therapy to the Barrett's esophagus. The result is the removal of the layer of Barrett's tissue lining the esophagus, followed by the regeneration of new healthy cells. Additional system features of the HALO360 System include:

-- Patented Electrode Array - A bipolar electrode array mounted on a balloon allows for the rapid delivery of controlled ablative energy to the diseased layer of the esophagus. The ablation is circumferential (360 degrees) within the esophagus lumen, and the ablation depth is controlled to about 1000 microns.

-- Advanced Esophageal Sizing - This unmatched feature automatically measures the esophagus's inner diameter quickly and accurately in less than six seconds.

-- Pre-Set Treatment Parameters - Energy density and other parameters are automatically set to optimize treatment for patients.

-- Catheter Recognition - A microchip recognizes the type and size of the catheter connected to the generator and automatically sets the power and energy requirements saving time, simplifying the procedure and enhancing safety.

-- Automatic Inflation and Deflation - The generator automatically inflates and deflates sizing and ablation catheters at the push of a button, facilitating an overall procedure time averaging about 26 minutes.

"BARRX Medical is focused on the development of advanced ablation therapy for the treatment of Barrett's esophagus, a known precursor to esophageal adenocarcinoma," said David S. Utley, M.D., Chief Medical Officer, BARRX Medical, Inc. "The HALO360 System is an endoscopic, non-surgical tool that will enable physicians to safely and effectively eliminate Barrett's esophagus, rather than simply observing the disease in hopes that it won't progress."

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, 70 percent of patients were Barrett's-free (at twelve- month 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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