Off topic: gastroesophageal reflux

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April 24, 2000 - Sunnyvale, California

"FDA Gives Curon Medical Clearance to Market its Stretta™ Procedure to Treat Reflux Disease"New Minimally Invasive Outpatient Procedure Uses Radiofrequency Energy to Stop Reflux, Which Afflicts Over 14 Million Adults in the U.S.

By: Helen Shik and Jayme ManiatisSchwartz Communications, Inc.hshik@...781/684-0770

Sunnyvale, CA–April 24 , 2000–Curon Medical, Inc. (formerly Conway Stuart Medical, Inc.) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Stretta™ System for the treatment of gastroesophageal reflux disease, more commonly referred to as GERD or chronic heartburn. The Stretta Procedure is a minimally invasive, outpatient procedure that uses radiofrequency energy to treat reflux.

GERD afflicts more than 14 million adults in the U.S. alone. The most common symptoms GERD sufferers often endure are significant heartburn and acid regurgitation. Other symptoms include difficulty swallowing, cough, sore throat, hoarse voice, chest pain, sleep disturbance and breathing difficulties due to exacerbation of asthma. A study published in the New England Journal of Medicine recently found that those with at least one weekly occurrence of heartburn are eight times more likely to develop esophageal cancer. Worldwide, patients and insurers spend $14 billion for anti-heartburn medications each year. Most GERD sufferers must take daily doses of medication for a lifetime.

"We are extremely pleased with the FDA’s clearance today of the Stretta System," said , President and Chief Executive Officer of Curon Medical. "In addition to chronic heartburn, GERD sufferers endure many other symptoms that impact all aspects of their lives. All of us at Curon Medical look forward to working with gastroenterologists around the country to make this outpatient procedure available to those who really need it."

GERD is caused by a weakened lower esophageal sphincter (LES) between the esophagus and stomach that allows bile and acid from the stomach to reflux back up into the esophagus, causing heartburn and irritation of the esophagus. GERD symptoms can be triggered by certain acidic foods or simple exercise. The Stretta Procedure is a minimally invasive outpatient procedure performed by a gastroenterologist in 60 minutes or less. The Stretta Procedure applies controlled radiofrequency energy through a flexible catheter to the lower esophageal sphincter improving the barrier function of the valve to stop reflux. The Stretta Procedure was evaluated in a clinical study conducted at 14 centers in the U.S. with 130 patients. For the 47 study patients for whom 6-month follow up data is currently available, 70% were able to discontinue all acid suppressing medications and 87% discontinued proton pump inhibitor medications. Stretta reduced the exposure of the esophagus to acid in the majority of patients, as well as significantly reducing heartburn and regurgitation. Most Stretta patients have now resumed normal diets and active exercise routines, which had been previously modified due to the symptoms of GERD.

The most common treatment for GERD is daily over the counter and prescription medication for the lifetime of the patient. Some sufferers opt for a surgical procedure called fundoplication, which can be performed laparoscopically or as an open abdominal procedure requiring a two to four day hospital stay and long recovery time. The Stretta Procedure offers patients a minimally invasive, outpatient solution that is quick and allows patients to return to normal activities the following day.

"For GERD sufferers the symptoms are quite serious and the options have previously been limited to either lifetime medication or invasive surgery. The Stretta Procedure offers an attractive alternative treatment option for patients who may not want to stay on medications and do not want to undergo surgery," explains Neil Stollman, MD, Director of Clinical Gastroenterology, San Francisco General Hospital and Assistant Professor of Medicine, University of California, San Francisco, and a Stretta Procedure clinical investigator while at the University of Miami. "The results from the clinical study so far are promising, and we are seeing sustained improvement in patients six months out. That is very encouraging. Patients should discuss this option with their gastroenterologists."

"Because of my reflux disease, I was forced to take daily medications to control my heartburn symptoms. I was forced to limit my diet, which was especially hard since my husband and I enjoyed travelling and trying out different cuisine. I was eating baby food at one point. I also curtailed exercise and hobbies since even the slightest movements triggered my heartburn symptoms. I stayed in an unfulfilling job simply because my symptoms drained my energies so much," explains Aline Humphrey, a registered nurse, and one of the first patients treated with the Stretta Procedure in the clinical trial. "It’s been a year since I had the Stretta procedure and I feel great. I’m eating the foods I love again, and I’m back to biking, gardening and sculpting again. I’ve changed jobs and feel like a new person."

About GERD Reflux disease, commonly referred to as GERD, is caused by a weakness in the lower esophageal sphincter (LES) that allows food and stomach acid to reflux back up into the esophagus. GERD sufferers often endure significant heartburn and acid regurgitation. Other symptoms include difficulty swallowing, cough, sore throat, hoarse voice, chest pain, sleep disturbance and breathing difficulties due to exacerbation of asthma. Most GERD patients must take daily doses of over the counter and prescription medications for a lifetime to control their symptoms. Some GERD sufferers opt for a surgical procedure called fundoplication. The fundoplication can be performed laparoscopically or in some cases as an open abdominal procedure often requiring a two to four day hospital stay and a substantial recovery period.

About the Stretta ProcedureThe Stretta Procedure is a minimally invasive, outpatient procedure performed by a gastroenterologist in 60 minutes or less. A physician endoscopically delivers controlled radiofrequency (RF) energy to the lower esophageal sphincter (LES) muscle and gastric cardia to create thermal lesions. As the lesions heal, the barrier function of the LES is augmented, reducing the frequency of reflux events. Because there is no hospital stay involved with the Stretta Procedure, patients undergoing the procedure are able to participate in normal activities the following day.

About Curon Medical Curon Medical, Inc. (formerly Conway Stuart Medical, Inc.) of Sunnyvale, Calif., is focused on developing cutting edge technology therapies using radiofrequency energy for the treatment of digestive system disorders. The Company’s initial product offering, the Stretta™ System, is a minimally invasive treatment for gastroesophageal reflux disease or GERD. The Stretta Procedure has been cleared by the U.S. Food and Drug Administration for use in the U.S. and has CE Mark approval for use in Europe. The Stretta Procedure is performed on an outpatient basis in 60 minutes or less by a gastroenterologist. Most Stretta patients are able to return to normal activity the following day. Curon Medical can be found on the Web at www.curonmedical.com

Stretta Procedure is a trademark of Curon Medical Inc.