Implantica AG said the FDA has granted Premarket Approval (PMA) for RefluxStop, the company's implant-based treatment for gastroesophageal reflux disease (GERD). The approval allows Implantica to begin commercial launch activities in the United States, the world's largest medical device market.
The approval follows the FDA's full review of the RefluxStop PMA application, including the long-term clinical evidence supporting the 5-year safety and effectiveness of the therapy.
RefluxStop is designed to address the underlying cause of acid reflux by restoring and maintaining the natural anatomy of the gastroesophageal junction, without encircling or applying pressure on the food passageway.
"FDA approval changes our focus from preparation to execution. As the world's largest medtech market, the United States represents a substantial commercial growth opportunity for Implantica, and we are very excited to begin the U.S. launch of RefluxStop. The initial rollout will be targeted, focusing on selected leading U.S. centers and reflux surgeons. 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," said Implantica CEO Dr. Peter Forsell in a statement.
