Implantica AG (publ) announced it has completed a pre-submission to the U.S. Food and Drug Administration (FDA) for RefluxStop™, a CE-marked medical implant for the prevention of gastroesophageal reflux disease (GERD). Implantica expects to receive an initial meeting with the FDA within 75-90 days of the pre-submission filing date, at which point the company will have a better understanding of the path forward for FDA approval. In addition to causing much discomfort and pain, acid reflux can also lead to serious consequences with 10%-20% of daily sufferers developing pre-cancerous changes in the lower esophagus, so-called Barrett's esophagus, as a result of stomach acid repeatedly coming in contact with the lining of the esophagus. Current surgical acid reflux treatments function by compressing the food passageway, often causing several unnecessary complications. RefluxStop™ has a completely different design principle, which according to Implantica's clinical investigation achieves better results without the complications associated with existing surgical treatments.