Medical technology company Implantica AG (Nasdaq First North Premier Growth Market: IMP A SDB) announced on Wednesday that it has submitted its final response to the US Food and Drug Administration (FDA) regarding Module 3 of the Premarket Approval (PMA) application for its RefluxStop device for gastroesophageal reflux disease.

This submission addresses remaining FDA questions, including additional testing requested after the 100-Day Meeting.

The company said that the filing also covers completion of the full PMA review process, including all three modules and multiple pre-approval inspections conducted by the FDA. These inspections, covering manufacturing sites, the quality system, and clinical trial oversight, were reported as successfully completed.

RefluxStop is a surgical treatment designed to restore the natural anatomy of the body for acid reflux patients without compressing the food passageway, with clinical data including a five-year follow-up supporting safety and efficacy. Implantica said the FDA submission is supported by peer-reviewed publications and long-term clinical outcomes from its pivotal study.

The company is positioned for potential US market approval pending FDA review of the PMA application.