FDA Grants PMA to Implantica’s RefluxStop® for GERD Treatment

Implantica AG announced on August 20, 2026, that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for RefluxStop® (NCT02759094), the company’s implant-based treatment for gastroesophageal reflux disease (GERD). The approval enables Implantica to begin commercial launch activities in the United States, the world’s largest medical device market.

The FDA approval follows the agency’s review of the RefluxStop® PMA application, including long-term clinical evidence supporting the therapy’s five-year safety and effectiveness. Implantica said the approval marks an important regulatory milestone and enables the company to move toward commercialization in the U.S. market.

RefluxStop® Designed to Preserve the Natural Anatomy of the Gastroesophageal Junction

RefluxStop® is designed to treat GERD by restoring and maintaining the natural anatomy of the gastroesophageal junction without encircling or applying pressure to the food passageway.

The device is intended to maintain the lower esophageal sphincter in its natural anatomical position, supporting physiological function while reducing reflux. This approach differs from conventional anti-reflux surgical procedures that typically involve wrapping or constricting the esophagus. Implantica says such procedures can be associated with swallowing difficulties, inability to belch or vomit, and gas bloating.

According to Implantica, RefluxStop® is designed to restore the body’s natural anatomy and physiology without encircling the food passageway.

FDA Indication Covers Acid and Non-Acid Reflux

RefluxStop® is an implantable sterile medical device indicated for the treatment of acid and non-acid reflux in patients diagnosed with GERD.

The device is designed to maintain the gastroesophageal junction in a defined intra-abdominal position, supporting natural lower esophageal sphincter function and reducing reflux episodes. The RefluxStop® Deployment Tool is indicated for patients diagnosed with GERD based on abnormal impedance-pH and/or pH testing who are candidates for RefluxStop® implantation.

Five-Year Clinical Evidence Supports the Regulatory Review

The FDA approval includes consideration of long-term clinical evidence supporting five-year safety and effectiveness of RefluxStop®. Implantica has reported published five-year clinical outcomes from its CE Mark clinical investigation, providing longer-term evidence on the device’s performance and safety.

The company previously reported that the FDA had reviewed all three PMA modules and completed six pre-approval inspections covering manufacturing sites, quality systems and clinical-trial activities before the final regulatory decision.

The RefluxStop® clinical development program includes a prospective, open-label, multicenter, single-arm clinical investigation registered under NCT02759094. The study evaluated the safety and effectiveness of RefluxStop® in patients with GERD and subsequently generated longer-term follow-up data.

RefluxStop® Received European CE Mark in 2018

RefluxStop® received its European CE Mark certification on August 8, 2018, following a multicenter clinical investigation evaluating the safety, effectiveness and performance of the device in patients with GERD. The CE Mark enabled Implantica to market and sell RefluxStop® in member countries of the European Economic Area and Switzerland.

Since then, the company has accumulated several years of commercial experience in Europe. Implantica reports that nearly 1,800 patients have been treated with RefluxStop®, supported by more than 60 Centers of Excellence across nine European countries. The company has also reported published five-year clinical outcomes from its European clinical program.

Targeted U.S. Commercial Launch Planned

Following the FDA approval, Implantica plans to begin a targeted U.S. commercial rollout focused initially on selected leading centers and reflux surgeons.

The company expects adoption to build gradually because physicians will require training and individual sites will need to complete activation activities. Implantica said its initial commercial strategy will focus on surgeon training, site preparation and establishing a foundation for longer-term market expansion.

Dr. Peter Forsell, CEO and founder of Implantica, said the FDA approval represents the culmination of years of clinical development, scientific work and regulatory review and enables the company to bring RefluxStop® to the U.S. market.

Implantica estimates that approximately 78 million people in the United States suffer from acid reflux. The company views the U.S. market as a significant commercial opportunity for RefluxStop®, although the initial launch is expected to be selective rather than nationwide.

What the FDA Approval Means for GERD Treatment

The PMA approval expands the surgical treatment options available to patients with GERD in the United States. RefluxStop® represents an implant-based approach designed to maintain the natural anatomy and physiological function of the gastroesophageal junction rather than encircling or applying pressure to the food passageway.

The regulatory milestone also marks the transition of RefluxStop® from a European commercial product to a therapy entering the U.S. market after FDA review of its PMA application and supporting long-term clinical evidence. Implantica’s next steps will focus on surgeon training, site activation and gradual expansion of access.

Reference

Implantica receives FDA approval for RefluxStop® – Opening the U.S. market – Implantica