NIJMEGEN, the Netherlands, October 13, 2015 – EndoStim, a medical device company developing neurostimulation therapy for gastroesophageal reflux disease (GERD), announced today that InEK, the German Institute for the Hospital Remuneration System, has decided to approve the request of DGVS (German Society for Digestive and Metabolic Diseases) and assign a permanent DRG (Diagnosis Related Group)¹ code covering reimbursement for EndoStim therapy to treat GERD in Germany.²
With this new reimbursement code active as of January 1, 2016, reflux surgery centers in Germany will be able to receive coverage for the EndoStim procedure and device. So far, EndoStim has been available at selected sites in limited volumes under the NUB program.³ The DRG approval will allow every eligible patient in Germany to have access to the procedure after an appropriate screening process.
“We will maintain our focus on developing centers of excellence and working with interdisciplinary teams of gastroenterologists and surgeons to roll-out our technology to patients in need. We thank DGVS for their support and look forward to continue working closely together on making EndoStim part of the spectrum of reflux standard of care,” stated Wouter Donders, Vice President of Sales & Marketing, EMEA. “We would also like to thank all physicians in Germany who have been using this system since 2013, helping demonstrate the value of EndoStim’s technology.”
“EndoStim targets the disease in a different way, by keeping the patient’s anatomy intact and using neurostimulation to correct the function of the lower esophageal sphincter – the root cause of the disease. As a result, patients generally avoid having side effects and therapy is adjustable in the gastroenterology clinic after the initial procedure,” added Professor Joachim Labenz, Chief of Internal Medicine at Diakonie Klinikum Jung-Stilling Hospital in Siegen, Germany. “The favorable decision from InEK shows their acknowledgement of the significant need for such a technology – 30% of GERD patients are insufficiently treated with PPI medication and many are adverse to prior surgical techniques due to risk of side effects.”
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.
3. NUB: Neue Untersuchungs- und Behandlungsmethoden