Implantica receives FDA approval for GERD implant RefluxStop

The U.S. Food and Drug Administration has granted Implantica AG Premarket Approval for RefluxStop, an implant-based treatment for gastroesophageal reflux disease (GERD). The approval allows the medtech company to commence commercial launch activities in the United States. After a thorough review of the RefluxStop Premarket Approval application, the FDA concluded that the therapy is both safe and effective for a period of five years.

RefluxStop aims to address the core issue of acid reflux by restoring and maintaining the natural anatomy of the gastroesophageal junction, instead of encircling or applying pressure to the food passageway. According to Dr. Peter Forsell, CEO and founder of Implantica, the achievement marks a significant milestone for the company, reflecting years of clinical development and regulatory review.

Approximately 78 million people in the United States suffer from acid reflux. RefluxStop has already gained considerable experience in clinical practice in Europe, where more than 1,800 patients have been treated at over 60 centers across nine European countries. The company plans to introduce RefluxStop in the U.S. market gradually, focusing initially on selected centers and reflux surgeons.

Physicians will require training and site activation to establish RefluxStop at each center, as commercial adoption is expected to grow steadily. RefluxStop is specifically indicated for patients diagnosed with GERD, characterized by abnormal impedance pH and/or pH testing. By maintaining the gastroesophageal junction in a specific position within the abdominal cavity, the device enables the lower esophageal sphincter to function naturally.

Implantica, which is listed on Nasdaq First North Premier Growth Market in Stockholm, also holds a CE mark for RefluxStop in Europe.