St Louis, MO and Nijmegen, the Netherlands – May 5, 2015
EndoStim, a medical device company developing lower esophageal sphincter (LES) stimulation therapy for gastroesophageal reflux disease (GERD) announced long-term, 3-year, positive safety and efficacy results. The results demonstrated an excellent control of reflux symptoms of both heartburn and regurgitation and the “gold-standard” esophageal acid exposure (measured by 24-hour esophageal pH test) with near-complete elimination of dependence on daily PPI medications.
The results were presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Nashville, TN. The study included 25 patients with severe GERD and an average duration of 11 years. All patients were taking daily proton pump inhibitor (PPI) medication for an average duration of 5.6 years prior to enrollment in the study.
In this study, all fifteen patients available for this report demonstrated better GERD-related quality of life at 3-year follow-up on EndoStim therapy than at their baseline on PPI therapy.
Importantly, patients’ median esophageal acid exposure, the most objective gold-standard measure of GERD, significantly improved from acid exposure of 10% of the day at baseline to 3% of the day at 3-year follow-up on EndoStim therapy (≤4% of the day is considered normal). These results demonstrate a sustained control of abnormal acid in the esophagus at 3 years on EndoStim therapy, consistent with previously reported outcomes in the same cohort of patients after two years of therapy [Surgery. 2015; 157(3):556-567].
Notably, no patients complained of dysphagia or any untoward sensation from the therapy and no therapy related adverse events were reported between the 2 and 3-year follow-up period.
“Esophageal acid exposure is the hallmark of this disease,” said Prof. Tom DeMeester, Professor Emeritus at the University of Southern California, Keck School of Medicine. “It’s encouraging for a new therapy to demonstrate sustained control of esophageal acid exposure for 3 years with remarkably few side effects.”
Results of an ongoing international multicenter trial in 10 sites worldwide have recently confirmed and validated the positive outcomes of this trial.
EndoStim is a venture-backed medical device company based in St. Louis, Missouri, and the Hague, the Netherlands.
EndoStim’s neurostimulation therapy is a minimally-invasive, long-term treatment for severe reflux patients that directly targets the patient’s weak or dysfunctional lower esophageal sphincter (LES) muscle between the stomach and the esophagus – often the underlying cause of reflux.
The EndoStim system is CE Marked for patients with gastro-esophageal reflux disease with symptom duration of 6 months or longer. EndoStim 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.
About Reflux Disease
Gastroesophageal reflux disease is a chronic disease that affects hundreds of millions of patients worldwide, and often requires lifelong treatment with acid blocker medications. Symptoms generally occur when weakness or dysfunction in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal inflammation and damage. Acid reflux causes heartburn, regurgitation and can lead to Barrett’s esophagus and esophageal cancer. Millions of patients continue to suffer from bothersome GERD symptoms despite maximal medical therapy.