Clinics throughout Germany receive NUB approval for 2014
THE HAGUE, NETHERLANDS and ST. LOUIS, MO, February 13, 2014/ — EndoStim announced today that 40 hospitals in Germany have received NUB (Neue Untersuchungsund Behandlungsmethoden) approval for its EndoStim® LES Stimulation Therapy for gastroesophageal reflux disease (GERD) or acid reflux. This represents a significant increase from 2013 and an important step towards making EndoStim available to GERD patients throughout Germany.
EndoStim’s LES Stimulation therapy is a minimally-invasive, long-term treatment for severe reflux patients who are unsatisfied with medical therapy. After a simple procedure to place the EndoStim device, low energy stimulation therapy is automatically delivered each day to the lower esophageal sphincter (LES) at the junction of the stomach and esophagus. The stimulation is designed to improve the function of the patient’s weak or dysfunctional LES – often the underlying cause of reflux – resulting in significant improvement in GERD symptoms of both heartburn and regurgitation, and elimination of dependence on daily medications in most patients.
Published worldwide results consistently demonstrate excellent safety and efficacy as demonstrated by long-term control of acid in the esophagus, significant reduction in both daytime and nighttime reflux and regurgitation symptoms. Most importantly this therapeutic effect is achieved with minimal side effects, a significant advancement over traditional antireflux procedures.
Professor Ernst Eypasch, M.D., Chief of Surgery at Heilig-Geist Krankenhaus in Köln-Longerich, Germany, comments, “EndoStim therapy has the potential to dramatically improve quality of life of GERD patients. Advantageously, during the device implant the anatomy of the hiatus and cardia is left almost untouched, thus the unpleasant side effects of conventional fundoplication can be avoided.”
“We are truly excited to offer EndoStim therapy to a wider range of patients throughout Germany,” said Shai Policker, Senior Vice President of Operations at EndoStim. “We thank the dedicated surgeons and gastroenterologists in Germany who help bring this treatment innovation to clinical practice for the benefit of reflux patients. We also thank our partner in Germany, Promedia Medizintechnik, for their continued support, and the Assessment in Medicine (AiM) team for the great work on the NUB process. We will continue to work diligently with our treating physicians to establish EndoStim as a standard of care anti-reflux procedure.”
In addition to Germany, EndoStim is available in a number of countries throughout Latin America, Asia, and Europe, including the UK, Denmark and Switzerland.
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 esophagus and esophageal cancer. Millions of patients continue to suffer from bothersome GERD symptoms despite maximal medical therapy.
EndoStim is a venture-backed medical device company based in St. Louis, Missouri, and The Hague, The Netherlands.
The EndoStim system is CE Marked for patients with gastro-esophageal reflux disease with symptom duration of 6 months or longer. The EndoStim system is not approved for sale in the US and is limited by US federal law to investigational use only.