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BÂRRX Medical, Inc. Introduces New Minimally Invasive Tool for
Treating Barrett's Esophagus
HALO System Offers Physicians Fast, Effective
Therapy To Treat Precancerous Condition of the Esophagus
Sunnyvale, Calif. - March 6, 2006 - BÂRRX Medical,
Inc. today introduced the HALO 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 HALO 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 HALO
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 HALO 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 HALO 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 HALO
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 ~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.
"BÂRRX 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, BÂRRX Medical, Inc.
"The HALO 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 BÂRRX Medical, Inc.
BÂRRX 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 HALO
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% 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., BÂRRX Medical, Inc. was
founded in 2000 and is privately-held. Additional information about BÂRRX
Medical, Inc. and the HALO system is available
at www.barrx.com.
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