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Early esophageal cancer and pre-cancer eliminated with non-surgical
treatment combination
Endoscopic ablative therapy with HALO device leads to 100% patient response
rate
Sunnyvale, Calif.—May 20, 2008—BÂRRX Medical, Inc., a global technology leader in
treating Barrett’s esophagus, today announced the publication of two related European trials
which report a 100% eradication rate for early esophageal cancer and pre-cancerous
dysplasia using endoscopic resection followed by ablation therapy with the HALO ablation
system. Barrett’s esophagus is a complication of gastroesophageal reflux disease (GERD)
and is a known risk factor for esophageal cancer, the fastest growing cancer in the Western
world.
Results of the two studies were published in the May issue of Endoscopy, a medical journal
for gastroenterologists performing advanced endoscopic procedures. They were titled
“Effective treatment of early Barrett’s neoplasia with stepwise circumferential and
focal ablation using the HALO system,” and “Stepwise circumferential and focal
ablation of Barrett’s esophagus with high-grade dysplasia: results of the first
prospective series of 11 patients.” The investigators enrolled patients with Barrett’s
esophagus having early cancer and/or advanced dysplasia, used endoscopic resection to
remove focal abnormal areas, then used endoscopic ablative therapy with the HALO system
to eradicate all remaining diseased tissue. At one and two year follow-up, respectively, in
each trial, all patients were cured of their esophageal disease.
“This data confirms that early cancer and advanced dysplasia can be safely and effectively
treated with this non-surgical approach using endoscopic resection and ablation,” said
Amsterdam Medical Centre (AMC) gastroenterologist and Professor of Medicine Jacques
Bergman, M.D., who led the study in Amsterdam, the Netherlands. “We’re confident this
treatment can reduce the need for high risk surgical procedures and become the preferred
strategy for treating patients with Barrett’s esophagus and early esophageal cancer.”
A related study presented last year in May 2007 at an international gastroenterology meeting
reported that ablative therapy, as used in this trial, eradicated all the associated genetic
abnormalities of the early cancer and dysplasia in treated patients.
A current standard of treatment for advanced dysplasia and early cancer of the esophagus is
surgical removal of the esophagus (i.e. esophagectomy.) This surgical procedure is often
associated with significant patient morbidity and even mortality. Once cancer occurs, the
five year survival is poor. According to the American Cancer Society, 16,470 new diagnoses
and 14,280 deaths due to esophageal cancer will occur this year in the U.S.
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 HALO360 System, provides uniform and
controlled therapy at a consistent depth, which can remove Barrett’s esophagus and allow the
re-growth of normal cells. In the largest study conducted (AIM-II Trial), 98 percent of
patients were Barrett’s-free after two and a half years. 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. Over 14,000 procedures have been performed in over 200
hospitals around the world. Based in Sunnyvale, Calif., BÂRRX Medical, Inc. was founded
in 2000 and is privately-held. Additional information about BÂRRX Medical, Inc. and the
HALO ablation system of products is available at www.barrx.com.
About Endoscopy
Endoscopy, the official publication for the European Society of Gastrointestinal Endoscopy
(ESGE), publishes original, peer-reviewed articles on endoscopic procedures used in the
study, diagnosis, and treatment of digestive diseases. Over the past decades, it has become
one of the world's leading journals in GI endoscopy. Founded by Professor Ludwig Demling
in 1961, Endoscopy has grown in prestige and quality. This development has been enhanced
by the close ties which have been established with individual national endoscopic societies.
To date, twenty societies are affiliated to Endoscopy.
