Implantica AG (publ) announced feedback from its third pre-submission meeting with the U.S. Food and Drug Administration (FDA) for the approval of RefluxStop?. FDA indicated its willingness to accept a Premarket Approval (PMA) submission for review based solely on the existing long-term European data for RefluxStop?, which if approved, would allow for U.S. market entry without a premarket U.S. clinical trial. Implantica received helpful feedback from the FDA in its recent supplemental pre-submission meeting where the regulatory pathway of RefluxStop? was discussed. Due to the favorable clinical investigation results of RefluxStop?, FDA has agreed to receive a PMA marketing application based on existing European clinical data alone. Implantica will provide the FDA with additional longer-term safety and efficacy data from its ongoing European clinical investigation at 4.5 year follow-up and thereafter file a PMA marketing application. The company looks forward to cooperating with the FDA and appreciates their support thus far.