The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Issues Practice Guideline Addressing the Management of Gastroesophageal Reflux Disease and Barrett's Esophagus

By Barrx Medical Inc., PRNE
Monday, May 31, 2010

Endoscopic radiofrequency ablation deemed to have significant clinical utility in the treatment of patients with all clinical stages of Barrett's esophagus

SUNNYVALE, California, June 1, 2010 - BARRX Medical Inc., a leader in the development of minimally invasive
medical devices designed to remove precancerous tissue from within the
gastrointestinal tract, reported today that the Society of American
Gastrointestinal and Endoscopic Surgeons (SAGES) has issued a new practice
guideline for the surgical treatment of gastroesophageal reflux disease
(GERD). Left untreated, reflux of stomach contents such as acid and bile into
the esophagus in GERD patients often leads to injury and chronic inflammation
of the lining of the esophagus. A significant proportion of GERD patients are
thus predisposed to developing precancerous changes within the esophageal
lining, a condition called Barrett's esophagus, which can lead to esophageal
adenocarcinoma. In addition to providing recommendations for the surgical
management of GERD, the new SAGES guideline presents a number of
evidence-based recommendations for the management of Barrett's esophagus when
it develops in these patients.

The authors of the SAGES practice guideline provided a series of
systematically developed recommendations related to the management of GERD
and Barrett's esophagus based upon a rigorous review of all relevant
published scientific studies. Specific to the management of Barrett's
esophagus, the practice guideline deemed that patients with the most advanced
stages of Barrett's esophagus (high-grade dysplasia and intramucosal cancer)
may be treated with endoscopic therapy inclusive of radiofrequency ablation
(RFA) and/or endoscopic mucosal resection. Surgery remains an option for
these patients as salvage or primary therapy. For Barrett's patients with
earlier stages of disease (non-dysplastic and low-grade dysplasia), the
practice guideline states that "RFA has been shown to be safe, clinically
effective, and cost-effective in these disease states."

"I am pleased that SAGES's new practice guideline for the surgical
treatment of GERD includes recommendations for the management of Barrett's
esophagus as well," noted C. Daniel Smith, MD, immediate Past President of
SAGES, and Professor of Surgery and Chair of the Department of Surgery at
Mayo Clinic in Jacksonville. "Barrett's is common in our practice and is the
best known risk factor for the development of esophageal adenocarcinoma. We
incorporate radiofrequency ablation in our esophageal program at Mayo Clinic,
along with anti-reflux surgery, as an early intervention to avert cancer
development."

"The SAGES practice guideline is the first set of official
recommendations from a professional society which have included the most
recently published clinical trial outcomes related to the use of endoscopic
RFA for treating Barrett's esophagus," commented David S. Utley, M.D., chief
medical officer for BARRX Medical. "We are pleased that the SAGES guideline
has provided the recommendation that endoscopic RFA has clinical utility and
should be offered as an option for patients with non-dysplastic and
dysplastic Barrett's esophagus based on the quality of the clinical evidence.
Verification, by SAGES, that RFA is a medically necessary option for patients
with Barrett's is important as physicians, patients and payers consider this
endoscopic treatment."

About BARRX Medical, Inc.

BARRX Medical, Inc. develops endoscopic treatment solutions for Barrett's
esophagus and other chronic gastroenterological diseases. Barrett's is a
precancerous condition of the lining of the esophagus (swallowing tube)
caused by gastroesophageal reflux disease, or GERD. The company's HALO360 and
HALO90 ablation systems provide a uniform and controlled ablation effect,
which removes diseased tissue and allows re-growth of normal cells.

A multi-center randomized, sham-controlled study, published in the New
England Journal of Medicine in 2009, studied HALO radiofrequency ablation
applied in the highest risk Barrett's population (those having dysplasia).
The ablation group had a high rate of complete eradication of dysplasia and
intestinal metaplasia and significantly decreased the rate of disease
progression and cancer development, as compared to the control group. In
another study (AIM-II) published in Gastrointestinal Endoscopy, 98.4 percent
of patients were Barrett's-free after two and a half years of follow-up.

Both HALO systems are cleared by the FDA for use in the U.S. and both
have CE Mark for use in Europe. More than 50,000 procedures have been
performed in over 400 hospitals around the world. Based in Sunnyvale, Calif.,
BARRX Medical, Inc. was founded in 2000 and is privately-held. Additional
information is available at www.barrx.com.

About The Society for American Gastrointestinal Endoscopic Surgeons
(SAGES)

SAGES was founded in 1981 to support academic, clinical and research
achievement in gastrointestinal endoscopic surgery (www.sages.org). SAGES has
more than 6,000 physician members from the U.S. and 50+ other countries. The
society has a representative on the American College of Surgeons Board of
Governors, is a nominating member of the American Board of Surgery, and holds
a seat in the AMA House of Delegates. SAGES established the first endoscopic
and laparoscopic standards of training and practice for surgeons, initiated
the Framework for Post Residency Education and Training in Endoscopic
Surgery, and operates the pre-eminent Annual Congress in Endoscopic Surgery.

Kevin Knight (for media), P: +1-972-385-9384, M: +1-214-732-9392 , kmcinc at aol.com, or Gregory A. Barrett, BARRX Medical, Inc., P: +1-408-328-7308, gbarrett at barrx.com

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