Implantica AG (publ.) announced completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop?. In March, 16 foregut surgeons in the United States (U.S.) participated in a Human Factors Validation Study of the RefluxStop? procedure at Northwestern University's Simulation Lab in Chicago.

RefluxStop? is an innovative new surgical procedure for the treatment of gastroesophageal reflux disease (GERD). The goal of the study is to demonstrate how surgeons at varying levels of surgical experience from academic, community, and private clinics in the US, carry out the RefluxStop procedure.

In the next step of the study, an independent third party is evaluating the data collected during testing in Chicago. Findings are included in Implantica's application for an FDA PMA for RefluxStop. The completion of this Human Factors study marks a critical milestone, which Implantica hopes will significantly help advance the US market approval process and ultimately result in the widespread availability of RefluxStop in the US.