Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces the submission of the second clinical module of the Premarket Approval (PMA) application to the US FDA for RefluxStop™ along with responses to the FDA’s findings from the first module.
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.
