Implantica AG (publ.) announces the submission of the first module of the PMA application to the U.S. FDA for RefluxStop®, an innovative device for the treatment of Gastroesophageal Reflux Disease (GERD). The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application. This process provides for ongoing review and feedback from the FDA as the modules are submitted.

The second and third (final) modules are anticipated to be submitted to the FDA in three-month intervals later this year. An estimated 27% of the adult population in the U.S. struggle with GERD1 and 40% of GERD patients don't respond to PPIs, the most common medication to treat the disease.2 This leaves tens of millions of patients with limited options to treat the relentless, painful symptoms of GERD. Even worse, in the U.S. and EU, around 48,000 people die annually from esophageal adenocarcinoma, with strong indications in the literature to be caused by acid reflux.