The FDA has signed off on Implantica’s gastroesophageal reflux disease (GERD) implant as the medtech eyes a lucrative U.S. market.
Known as RefluxStop, the device works as an implant that is placed in the upper part of the stomach via keyhole surgery and is designed to help reduce or stop acid from entering the esophagus, reducing the need for long-term medication.
The implant went through the FDA’s rigorous Premarket Approval (PMA) process, which requires extensive five-year clinical data to demonstrate long-term safety and effectiveness.
RefluxStop has been on the European market since August 2018 and, according to Implantica, has helped treat 1,800 patients across more than 60 so-called Centers of Excellence.
The U.S. is estimated to have around 78 million GERD patients, making it one of the most common conditions in the country. Many patients are offered medication such as PPIs or diet changes/restrictions to help control their acid levels.
An implant is a more invasive procedure but is aimed at those who do not want or cannot tolerate current drugs.
“The initial rollout will be targeted, focusing on selected leading U.S. centers and reflux surgeons,” said Dr. Peter Forsell, CEO and founder of Implantica, in a statement.
“Commercial adoption is expected to build gradually, reflecting the physician training and site activation required to establish RefluxStop at each center. Our focus will be on disciplined execution, high-quality surgeon training, and building a solid commercial foundation for sustainable long-term growth.”
Implantica also announced that sales “have increased by more than 60% compared with the prior-year period, reflecting continued commercial growth across key European markets,” in a financial update after the FDA approval.
The medtech added in its update that it will be boosting its U.S. organization and working on the “establishment of logistics and distribution infrastructure.”