EndoGastric Solutions(TM) Announces Results of EsophyX(TM) Multi-Center GERD Study

Wednesday, February 27, 2008 General News
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REDMOND, Wash., Feb. 26 EndoGastric Solutions, the worldleader in natural orifice surgery products and procedures, announcesoutstanding results at the completion of 1-year follow-up on GERD patients inthe phase 2 multi-center study of the first generation transoral incisionlessfundoplication (TIF 1) procedure and first-generation EsophyX device.EndoGastric Solutions is the first company to successfully design trulyincisionless transoral surgical products that mimic the outcomes of the moreinvasive gold-standard antireflux surgeries, laparoscopic fundoplications(i.e. Nissen, Toupet or Hill procedures). The EsophyX device enables surgeonsand advanced interventional gastroenterologists to offer their patientssubstantive anatomical repair without incisions (no skin or internaldissection) for front-line surgical management of gastroesophageal refluxdisease (GERD) patients.

Dr. John Hunter, Professor and Chairman of the Department of Surgery atOregon Health & Science University in Portland, Oregon, states, "For years,the medical community has been looking for less invasive ways to treat GERDpatients to reduce their dependence on pharmaceuticals. Our department hasstudied the effects of these pharmaceuticals and is concerned that there areadditional detrimental effects that should be avoided. EsophyX is animpressive technology with impressive results that advances the treatment ofGERD a giant leap forward."

Dr. Todd Overcash, Medical Director of Bariatric and Minimally InvasiveSurgery at Munroe Regional Medical Center in Ocala, Florida, is the UnitedStates leader of NOS (Natural Orifice Surgery) procedures performed. He wasamong the first U.S. surgical teams that went to Europe last fall to train onthis new technique. He has now performed more EsophyX procedures than anysurgeon in the U.S. and states: "Having performed 38 advanced TIF procedureswith the EsophyX device in the last three months, I can attest that thisincisionless technique offers our patients a tremendous improvement in theirquality of life. It allows them the ability to eat foods and beverages theycould not tolerate before the procedure but, most importantly, it allows themto discontinue their use of GERD medications in the majority of cases, whichis especially important for women in the face of osteoporosis. With no skinincisions, no cutting of vessels, and no dissection of the fundus, the EsophyXdevice represents a new era in antireflux treatment and offers patients aninnovative, state-of-the-art surgical procedure that will allow them to nolonger live their lives pill-to-pill."

Dr. Scott Melvin, Professor of Surgery, Director of the Center forMinimally Invasive Surgery and Chief of the Division of General &Gastrointestinal Surgery at The Ohio State University (OSU) Medical Center,will be demonstrating this new TIF technique at a live case course at OSUFebruary 29th: "I am very impressed with the clinical results for EsophyX,including the reduction/elimination of hiatal hernia and reduction/eliminationof esophagitis. These multi-center study results confirm the 2 year outcomesseen in the first EsophyX study. With over 750 Natural Orifice Surgical casesperformed to date, utilizing EndoGastric Solutions technology platforms, it isclear that TIF is a mainstream procedure that most advanced foregut surgeonsshould be incorporating into their clinical practice. Any surgeon consideringbeing a natural orifice surgeon should come see the techniques and learn moreat our course."

"We are very pleased with the outstanding results of our first two GERDclinical studies," states Thierry Thaure, CEO of EndoGastric Solutions (EGS)Inc. "These results were achieved with the first version of the EsophyX deviceand TIF 1 procedure. We believe in continuous improvement and are alreadyteaching a much improved TIF 2 technique in our training center in Redmond,Washington that has shown even stronger o

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