FDA Approves Implantica's RefluxStop Implant for Gastroesophageal Reflux Disease

The US Food and Drug Administration has granted premarket approval to RefluxStop, Implantica's implant for gastroesophageal reflux disease (GERD), the Stockholm-listed company said late on August 20 in a release distributed through the MFN news service. Premarket approval is the FDA's pathway for high-risk devices, which requires a review of clinical evidence of safety and effectiveness.

Implantica said the approval followed the FDA's full review of its PMA application, including long-term clinical evidence on five-year safety and effectiveness, and allows it to begin commercial launch activities in the United States. The company did not publish the PMA number or the approved labeling in its announcement.

How the implant differs from current surgery

GERD is a chronic condition in which stomach contents flow back into the esophagus. According to Implantica, conventional anti-reflux operations typically rely on encircling the esophagus, and the company said those approaches are often associated with side effects such as swallowing difficulties, an inability to belch or vomit, and gas bloating.

RefluxStop is designed to keep the junction between the esophagus and stomach in its natural position inside the abdomen without encircling or applying pressure on the food passageway, the company said. Its stated indication is to treat acid and non-acid reflux in patients diagnosed with GERD; a separate RefluxStop Deployment Tool is indicated for implanting the device in patients whose GERD is defined by abnormal impedance pH or pH testing.

The company said five-year clinical outcomes for RefluxStop have been published in peer-reviewed journals. Its announcement did not summarize those results.

Commercial use in Europe, then a targeted US rollout

RefluxStop already carries a CE mark in Europe. Implantica said it has close to 1,800 patients treated, more than 60 centers of excellence across nine European countries and several years of commercial experience there. Nordic Life Science reported the approval on August 21, quoting the company.

"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 Peter Forsell, Implantica's founder and chief executive.

Forsell said the initial US rollout will be targeted, starting with selected leading US 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," he said.

The company described the approval as insider information under the EU Market Abuse Regulation and said it was submitted for publication at 23:05 Central European Summer Time on August 20. Implantica, which is listed on Nasdaq First North Premier Growth Market in Stockholm, did not give US pricing or a launch date.