First two patients at SurgOne Foregut Institute implanted in EndoStim’s LESS GERD clinical trial for gastroesophageal reflux disease (GERD)

ENGLEWOOD, Colo. and DALLAS, Dec. 1, 2016 /PRNewswire/ — SurgOne Foregut Institute and EndoStim, Inc., announced that the first two patients in Englewood, CO have been implanted with the EndoStim device in the Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) trial, at SurgOne Foregut Institute. The EndoStim system is a minimally-invasive implantable device designed to provide long-term reflux control by restoring normal function to the esophagus through neurostimulation.

GERD affects nearly 65 million people in the United States1. It occurs when stomach acid or other stomach contents flow back into esophagus, often caused by a weak valve, or sphincter, between the esophagus and the stomach called the lower esophageal sphincter (LES). Frequent and troublesome symptoms can include heartburn, regurgitation, sleep disruption, vocal impairment and respiratory complications. Most GERD is successfully treated with acid blocking medications such as proton pump inhibitors (PPI). However, nearly 30 percent of patients on PPI medication continue to suffer from symptoms. The traditional anti-reflux surgery is laparoscopic fundoplication surgery, a procedure in which the surgeon wraps the top of the stomach around the lower esophagus to reinforce the lower esophageal sphincter. While typically effective, fundoplication can cause significant side effects.

The LESS GERD trial will evaluate the safety and efficacy of the EndoStim Lower Esophageal Sphincter (LES) Stimulation System in patients with gastro-esophageal reflux disease (GERD) who experience symptoms despite taking high-dose proton pump inhibitor (PPI) medications.

“There is a significant need for an effective and less invasive procedure for reflux that will potentially help a large number of patients unsatisfied with current therapy options,” commented Dr. Reginald Bell, MD, F.A.C.S. and a principal investigator in the study.

“The LESS GERD clinical trial is a significant undertaking to generate the first randomized, controlled, double blind evidence for a treatment for chronic GERD,” said Rohan Hoare, Ph.D., President and Chief Executive Officer of EndoStim. “We are excited to begin this study in Englewood, CO and look forward to working with the world-renowned team at SurgOne Foregut Institute to establish EndoStim therapy in the United States.”

About the Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) Trial
The LESS GERD trial will examine the effects of the EndoStim LES Stimulation System on GERD outcomes such as: esophageal acid exposure; GERD symptoms (heartburn and regurgitation); ability to avoid dependence on PPI medications; and the effect on overall quality of life. A minimum of 110 subjects will be implanted with the EndoStim device. The study is open to GERD patients who are between the ages of 22 and 75; have been diagnosed with GERD; have taken daily PPI medication and whose GERD symptoms are not completely resolved or have side effects from the PPI; and have had no prior surgery involving the esophagus.

Patients seeking information on the trial should visit: www.lessgerd.com.

About SurgOne Foregut Institute and Dr. Reginald Bell
Reginald C.W. Bell M.D., F.A.C.S. is the founder of the SurgOne Foregut Institute. He has had extensive experience performing minimally invasive procedures on the esophagus and stomach with over 25 years in practice. He had dedicated his career to the evaluation and treatment of forgut disorders and has more experience than anyone in the region.

SurgOne Foregut Institute (SOFI) specializes in the diagnosis and surgical treatment of patients with foregut disorders. Foregut refers to of the upper portion of the GI tract – the esophagus and stomach. The most common disease of the foregut is GastroEsophageal Reflux Disease (GERD); however many other entities such as LaryngoPharyngeal Reflux (LPR), achalasia, gastroparesis, and esophageal and gastric cancer are also disorders of the foregut.

Our unique team of specialists engages in clinical research so we are able to provide patients with the most current treatments available.

About EndoStim
EndoStim is a medical device company based in Dallas, Texas, and Nijmegen, The Netherlands, developing and commercializing a revolutionary treatment for GERD. The EndoStim LES Stimulation System is CE Marked for patients with gastroesophageal reflux disease with symptom duration of six months or longer, and is available in a number of countries throughout Europe, Latin America, and Asia Pacific. The EndoStim system is not approved for sale in the US and is limited by US federal law to investigational use only. For more information, visit www.endostim.com.

1 National Institute of Diabetes and Digestive and Kidney Diseases, Definition and Facts for GER and GERD, http://www.niddk.nih.gov/health-information/health-topics/digestive-diseases/ger-and-gerd-in-adults/Pages/definition-facts.aspx. Accessed June 9, 2016.

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