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The National Institute for Health & Clinical Excellence (NICE) Approves the Use of Radiofrequency Ablation for Treatment of Barrett’s Esophagus

June 28, 2010

SUNNYVALE, Calif., June 28 /PRNewswire/ — BARRX Medical Inc., a world leader in products to treat pre-cancerous tissue in the esophagus, reported today that the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has published new guidelines approving the use of radiofrequency ablation for the eradication of dysplastic Barrett’s esophagus.

Barrett’s esophagus is a precancerous condition that affects over 6.6 million people around the world and is caused by chronic acid reflux otherwise known as GERD. In some patients, Barrett’s esophagus may progress to cancer of the esophagus known as adenocarcinoma. BARRX Medical markets the HALO radiofrequency ablation system that allows physicians to safely remove the diseased Barrett’s tissue so that new healthy tissue can grow back in its place. In clinical studies, treatment with the HALO System has been demonstrated to eliminate Barrett’s esophagus in over 90 percent of patients.

“The UK has one of the highest concentrations of Barrett’s esophagus in the world. Until now, esophagectomy (a surgical procedure to remove the patient’s esophagus) has been the standard of care,” noted Dr. Laurence Lovat, Senior Lecturer and Consultant Gastroenterologist at the University College Medical School, London. The first to use RFA in the UK, Dr. Lovat added, “We think radiofrequency ablation will play an important role in the endoscopic management of our patients.”

Greg Barrett, President and Chief Executive Officer at BARRX said, “NICE represents one of the most rigorous health technology assessment groups in the world. We are pleased that their guidance supports the use of radiofrequency ablation for patients with this particularly high risk disease.”

Dr. Paul Salmon, Trustee (and former Chair) of the Barrett’s Oesophagus Campaign stated, “Barrett’s represents one of the fastest growing and most deadly forms of cancer in the UK and is set to treble in the next decade. We are pleased to see NICE has identified radiofrequency ablation as an important tool in the fight against this disease.”

About BARRX Medical, Inc.

BARRX Medical, Inc. develops 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 HALO ablation systems provide a uniform and controlled ablation effect, which removes diseased tissue and allows re-growth of normal cells. There have been over 50,000 procedures of radiofrequency ablation for Barrett’s eradication performed around the world.

A multi-center randomized, sham-controlled study, published in the New England Journal of Medicine, 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.

Additional information is available at www.barrx.com.

About NICE and the Interventional Procedures (IP) Program

The National Institute for Health and Clinical Excellence (NICE) is the independent organization of the UK’s National Health Service responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

Assessment of the efficacy and safety of interventional procedures is carried out by NICE’s Interventional Procedures (IP) Program. NICE’s IP Program assesses the efficacy and safety of interventional procedures, with the aim of protecting patients and helping clinicians, healthcare organizations and the NHS to introduce procedures appropriately. By reviewing evidence, consulting widely, facilitating data collection and analysis, and providing guidance on the efficacy and safety of interventions, the Program enables clinical innovation to be conducted responsibly.

SOURCE BARRX Medical, Inc.


Source: newswire



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