Initial Results with the LESA Procedure & Enteryx Implantable Biopolymer for Treatment of Gastroesophageal Reflux Disease to be Presented at Digestive Diseases Week.

Medical & Health Writers

FOSTER CITY, Calif.--(BW HealthWire)--May 19, 2000

Enteric Medical Technologies of Foster City, California, has developed a, minimally invasive treatment for Gastroesophageal Reflux Disease (GERD) based on its proprietary, patented Enteryx(TM) implantable biopolymer. The Lower Esophageal Sphincter Augmentation (LESA(TM)) procedure is an outpatient, endoscopic procedure in which the Company's Enteryx biopolymer is injected into the wall of the esophagus to reinforce the lower esophageal sphincter.

Prof. Jacques Deviere, Chief of Gastroenterology at the Universite Libre de Bruxelles, Belgium, will report initial clinical results for the Lower Esophageal Sphincter Augmentation (LESA) procedure at Digestive Diseases Week 2000 in San Diego. The presentation will take place on Tuesday, May 23rd from 8:30-10:00AM at the symposium entitled "Innovations in Management of GERD."

In addition to the results of his pilot patient series, Prof. Deviere will also review the results of extensive pre-clinical animal studies of Enteryx and the LESA procedure performed at Indiana University Medical Center by Dr. Glen Lehman and the University of Southern California Medical Center by Dr. Jeffrey Peters.

According to Prof. Deviere, "Initial results have been very favorable. The procedure is performed in 15-30 minutes. There have been no complications and the patients can resume eating the evening of the treatment and normal activities the next day. 80% of patients had symptomatic improvement. Most importantly, whenever subjective improvements were demonstrated there was a corresponding improvement in objective measures"

Enteric Medical Technologies also announced that it has received approval from the U.S. Food and Drug Administration (FDA) to begin a multicenter clinical trial to evaluate its Enteryx implantable biopolymer for the treatment of GERD. The Company has also received CE Mark approval for the Enteryx biopolymer that will allow commercialization in Europe.

According to Dr. David Silverman, President and CEO of Enteric Medical Technologies, "We are extremely pleased with the preliminary results. To date, 21 patients have been treated worldwide. Collectively, these results provide a springboard for launching our FDA-approved multicenter study as well as our individual national trials in France, Germany and Italy."

GERD is defined as the failure of the anti-reflux barrier, allowing abnormal reflux of gastric contents into the esophagus. The basis for GERD is a mechanical disorder, which is caused by a defective lower esophageal sphincter, a gastric emptying disorder or failed esophageal clearance. These abnormalities result in a spectrum of disease ranging from "heartburn" to esophageal tissue damage with subsequent complications. GERD is also the second most significant "Quality of Life" issue in the U.S. after Cardiac Angina.

It is estimated that worldwide, over $14 billion is spent each year for medications to relieve the symptoms of reflux disease. As medication only treats the symptoms but not the underlying cause of the disease, most GERD patients need to take daily doses of medication for lifetime. For a small number of patients, a surgical procedure called fundoplication is available.

Enteric Medical Technologies of Foster City, California develops, manufactures and markets minimally invasive technologies for treatment of Gastrointestinal Disorders. The Company's new LESA procedure is an outpatient, endoscopic procedure in which the company's patented Enteryx implantable biopolymer is injected into the wall of the esophagus to reinforce the LES. Initial studies have shown the procedure to be performed in 20-30 minutes under mild sedation and patients resumed all normal activities the next day.