EndoStim announced today the renewal of a positive reimbursement decision in Germany, NUB Status 1, for its lower esophageal sphincter (LES) stimulation system, a minimally-invasive neurostimulation treatment for gastroesophageal reflux disease (GERD).
InEK, the German institute for the hospital remuneration system, is responsible for maintaining national reimbursement codes and policies impacting over 90% of the population, including the NUB program intended to facilitate the introduction of innovative medical technologies. NUB Status 1 designation, the highest level of NUB approval, allows for the 65 approved hospitals to negotiate for additional funding to cover EndoStim procedures.
This positive decision from InEK represents an important step towards expanding availability of EndoStim therapy to GERD patients across Germany, where EndoStim has been available since 2013.
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 offering will be made only by means of a prospectus.
Published worldwide results consistently demonstrate excellent safety and efficacy in treating both heartburn and regurgitation, along with elimination of dependence on daily GERD medication for most patients. Most importantly, this therapeutic effect is achieved with minimal side effects and preservation of natural anatomy, a significant advancement over traditional anti-reflux procedures.
“We are excited to see the impact that our technology has already had on improving the quality of life of the reflux patients who have been treated with EndoStim,” commented Wouter Donders, Vice President – Sales & Marketing EMEA, of EndoStim. “We will continue working with the leaders in reflux treatment toward making EndoStim a standard of care therapy for reflux patients in Germany.”
“Millions of patients in Germany continue to suffer from reflux symptoms despite taking medications for many years,” added Prof. Dr. Joachim Labenz, Chief of Internal Medicine at Diakonie Klinikum Jung-Stilling in Siegen, Germany, and the German Association of Gastroenterology (DGVS) Congress President. “A less invasive option which can treat the root cause of disease, such as EndoStim, could significantly improve these patients’ daily lives.”
In addition to Germany, EndoStim is available in a number of countries throughout Latin America, Asia, and Europe.
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.
NUB: Neue Untersuchungs- und Behandlungsmethoden
InEK: Institut für das Entgeltsystem im Krankenhaus