Implantica Receives FDA Feedback on RefluxStop Application

Medical technology firm Implantica announced that it has received feedback from the U.S. Food and Drug Administration (FDA) regarding the second module of its Premarket Approval (PMA) submission for the RefluxStop device, intended for the treatment of acid reflux.

The FDA has completed its review of Module 2, which included clinical data, usability testing, and labeling information. Implantica stated that the feedback provided by the FDA was largely minor and does not present any impediment to the overall PMA approval process. The company plans to submit its responses to this feedback in conjunction with the final Module 3 submission in the near term.

"We are thankful to the FDA for their review of Module 2 and are pleased to receive their positive feedback on our submission thus far," said Dr. Peter Forsell, Implantica's founder, CEO, and inventor of RefluxStop. "Module 2 includes the results of the RefluxStop clinical study and is, by far, the most important module for this PMA from our perspective. The 5-year outcomes, along with reported literature data, are extremely positive and indicate that RefluxStop may revolutionize this treatment field."

Implantica aims to bring RefluxStop to the U.S. market as soon as possible. The device currently holds CE marking in Europe and is available in several countries.