The second module submitted earlier this week for the RefluxStop™ PMA is the most crucial module of the three-module process for FDA approval. The outcome of our clinical study submitted to FDA shows fantastic positive results, which has echoed around the surgical community, fueling a vibrating interest in RefluxStop among surgeons and GIs all around the world and especially in the U.S. Together with Module 2, responses to the FDA’s findings from Module 1 were also submitted, which the company believes are minor findings. In addition, the finalization of Module 3 is ongoing. The US FDA has agreed to a modular submission process for the RefluxStop™ PMA application, which allows for ongoing review and feedback from the FDA as each module is submitted.

Dr. Peter Forsell, CEO of Implantica, says, “The incredible enthusiasm for RefluxStop™ among top surgeons at the recent annual American Foregut Society and European Foregut Society meetings is a testimony to the immense demand for innovation in the surgical treatment of GERD. This support is growing fast, fueled by RefluxStop’s excellent clinical outcomes, both in our pivotal 5-year study but also supported by multiple centers around Europe presenting their equally excellent results. This even further demonstrates the potential of RefluxStop™ to become the standard of care for GERD patients in the U.S. pending final FDA approval.”