Implantica AG, a medical technology company developing implant-based treatments, announced that the U.S. Food and Drug Administration has granted Premarket Approval for RefluxStop, its treatment for gastroesophageal reflux disease, or GERD.
The approval allows Implantica to begin commercial launch activities in the United States, giving the company access to the world’s largest medical device market.
According to Implantica, the FDA approval followed a full review of the RefluxStop PMA application, including clinical data supporting the treatment’s safety and effectiveness over five years.
RefluxStop is designed to address the underlying cause of acid reflux by restoring and maintaining the natural anatomy of the gastroesophageal junction. Unlike some surgical approaches, the implant does not encircle or place pressure on the food passageway.
“FDA approval of RefluxStop is a defining landmark for Implantica and the culmination of many years of clinical development, scientific work, and rigorous regulatory review,” said Dr. Peter Forsell, CEO and founder of Implantica. “Most importantly, it means that we can now bring RefluxStop to the United States, where an estimated 78 million people suffer from acid reflux.”
Forsell said the company enters the U.S. market with several years of commercial experience in Europe, where nearly 1,800 patients have been treated and more than 60 Centers of Excellence have been established across nine countries. Implantica has also published five-year clinical outcomes for the treatment.
The company said it has also maintained scientific engagement with U.S. surgeons and experts as it prepared for regulatory approval and commercialization.
“FDA approval changes our focus from preparation to execution,” Forsell said. “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.”
Implantica plans an initial targeted rollout at selected U.S. medical centers and among reflux surgeons. The company expects adoption to build gradually as physicians receive training and individual sites are activated.
Forsell said Implantica will focus on surgeon training and establishing a commercial foundation aimed at supporting long-term growth in the U.S. market.
