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HALO³⁶⁰ Ablation System cures 70% of patients at one-year follow-up

Sunnyvale, Calif.—February 1, 2007—BÂRRX Medical, Inc. today announced the publication of favorable long-term follow-up results from the “Ablation of Intestinal Metaplasia” clinical trial in Gastrointestinal Endoscopy, a medical journal for gastroenterologists who perform advanced endoscopic procedures. In this scientific paper entitled, “Circumferential Endoscopic Ablation of Barrett Esophagus using a Balloon-Based System: One-Year Follow-up of 100 Patients,” investigators reported that patients with a premalignant esophageal condition, known as Barrett’s esophagus, were safely treated with the HALO³⁶⁰ Ablation System. At one-year follow-up, 70% of these patients were completely free of the disease.

Barrett’s esophagus affects 3 million or more U.S. adults and is a complication of a disorder called gastroesophageal reflux disease or GERD. The current management for Barrett’s esophagus includes an upper endoscopy every 1 to 3 years with biopsies of the diseased tissue. Deemed “surveillance endoscopy”, this regimen is continued for the life of the patient, or until the disease is shown to progress to more dangerous stages, like dysplasia or cancer. If cancer progression is detected, surgical removal of the entire esophagus is recommended. Esophageal cancer of this type is the fastest growing cancer in the U.S., in terms of the number of new cases per year.

Virender K. Sharma, M.D., Associate Professor of Medicine, Mayo Clinic in Arizona, was the first author on this study, which was co-authored by physicians from 7 other prestigious U.S. medical centers. “Publication of the one-year results of the AIM Trial represents a very important milestone in the advancement of this ablative technology for our patients with Barrett’s esophagus,” says Dr. Sharma. “Until now, the patient with Barrett’s esophagus was relegated to a lifetime of frequent endoscopic surveillance procedures to watch for progression to more dangerous forms of the disease, like dysplasia and cancer. The results of this study suggest that we can safely and proactively eliminate Barrett’s esophagus at the very earliest stage, rather than limiting ourselves to passive observation of the disease for progression. This has been a welcome change in the management strategy for our patients with Barrett’s esophagus.”

In this study, patients with the earliest stage of Barrett’s esophagus (intestinal metaplasia) received ablation using the HALO³⁶⁰ Ablation System, a balloon-based radiofrequency device designed to remove the diseased cells using controlled heat. Procedures were performed non-surgically, using endoscopy and sedation, which allowed the patient to return to normal activity after the procedure. Ablation treatment was followed by frequent endoscopy with biopsy procedures over the ensuing 12 months to determine if the disease had been fully eliminated. At one year, 70% of patients were cured of Barrett’s, while the remaining patients had near complete resolution of their disease.

“The results of the AIM Trial prompted BÂRRX Medical to develop a focal ablation device, called the HALO⁹⁰ Ablation System, which can be used as a complimentary therapy to circumferential ablation with the HALO³⁶⁰ device,” said David S. Utley, M.D., Chief Medical Officer, BÂRRX Medical, Inc. “The AIM Trial has been extended beyond that which is reported in this current publication in order to treat any residual Barrett’s with the new device. With patient follow-up now approaching 2.5 years for the trial, it is expected that the focal ablation procedure will even further improve the efficacy outcomes of this ablative technology.”

About BÂRRX Medical, Inc.

BÂRRX Medical, Inc. develops treatment solutions for Barrett’s esophagus. Its first product, the HALO³⁶⁰ Ablation System, uses a balloon-based electrode to ablate Barrett’s tissue circumferentially within the esophagus. A newer product from BÂRRX Medical, the HALO⁹⁰ Ablation System, is an electrode system that is mounted on the end of an endoscope, allowing the physician to treat focal areas of diseased tissue. Both HALO Systems provides uniform and controlled therapy at a consistent depth, which can remove Barrett’s esophagus and allow the regrowth of normal cells. Both systems are cleared by the U.S. Food and Drug Administration and are commercially available. Based in Sunnyvale, Calif., BÂRRX Medical, Inc. was founded in 2000 and is a privately held company. Additional information about BÂRRX Medical, Inc. and the HALO³⁶⁰ System is available at www.barrx.com.

About Gastrointestinal Endoscopy

Gastrointestinal Endoscopy, the official publication for the American Society for Gastrointestinal Endoscopy, publishes original, peer-reviewed articles on endoscopic procedures used in the study, diagnosis, and treatment of digestive diseases. Gastrointestinal Endoscopy has become the international forum for the newest developments in the specialty, bringing readers challenging reports from leading authorities throughout the world.