First patient at UNC implanted in EndoStim’s LESS GERD clinical trial for gastroesophageal reflux disease (GERD)

CHAPEL HILL and DALLAS, FEBRUARY 15, 2017 – University of North Carolina and EndoStim, Inc., announced that the first patient in Chapel Hill has been implanted with the EndoStim device in the Lower Esophageal Sphincter Stimulation for GERD (LESS GERD) trial, at UNC. 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 States[1]. 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.

“Many of my patients get an incomplete response of their GERD symptoms to medical therapy,” commented Dr. Nicholas J. Shaheen, MD, MPH, Professor of Medicine and Epidemiology and

Chief, Division of Gastroenterology & Hepatology  at the University of North Carolina School of medicine and a principal investigator in the study. “I am excited about the possibility of giving them better symptom relief and control of their GERD with this new therapeutic approach”

“We are excited to start the LESS GERD Clinical trial at UNC to generate evidence for a novel new treatment for Chronic GERD, an under treated disease that is disrupting the lives of millions of patients worldwide,” said Rohan Hoare, Ph.D., President and Chief Executive Officer of EndoStim. “Unlike many common treatment options that work to alleviate GERD symptoms, EndoStim targets the underlying pathophysiology of GERD with the potential to restore normal function to the lower esophageal sphincter (LES).”

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 the University of North Carolina at Chapel Hill



The University of North Carolina at Chapel Hill, the nation’s first public university, is a global higher education leader known for innovative teaching, research and public service. A member of the prestigious Association of American Universities, Carolina regularly ranks as the best value for academic quality in U.S. public higher education. Now in its third century, the University offers 77 bachelor’s, 110 master’s, 64 doctorate and seven professional degree programs through 14 schools and the College of Arts and Sciences. Every day, faculty, staff and students shape their teaching, research and public service to meet North Carolina’s most pressing needs in every region and all 100 counties. Carolina’s 317,000-plus alumni live in all 50 states and 156 other countries. More than 167,000 live in North Carolina.

 

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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