Implantica AG said the U.S. Food and Drug Administration granted Premarket Approval (PMA) for RefluxStop®, its implant-based treatment for gastroesophageal reflux disease (GERD), opening the U.S. market and allowing the company to begin commercial launch activities. The company is expanding its U.S. organization and establishing logistics and distribution infrastructure, while planning a targeted rollout through selected centers and reflux surgeons. In Europe, second-quarter RefluxStop® sales rose 66% to TEUR 717, while first-half net sales increased 34% to TEUR 1,574. The company also reported a major independent study of 602 patients across 22 centers in six European countries, with serious safety events and reoperations below 2%, and expanded its European network to more than 60 Centers of Excellence.