Implantica publishes Interim Report January – March 2024 (Q1)
RefluxStop™ on path to become standard of care for acid reflux treatmentSignificant events in the first quarter of 2024 · Submitted Premarket Approval (PMA) application for RefluxStop™ to U.S. FDA · First of three modules submitted · Next two modules to be submitted in estimated 2 three-month intervals · One time costs of EUR 2.5 million attributed to the FDA process including the Usability study during Q1 · Completed Human Factors Validation Study with 16 U.S. surgeons as part of the FDA PMA process · 20 U.S. foregut surgeons trained on the RefluxStop procedure