Following a lengthy period of clinical evidence generation, Implantica’s RefluxStop has secured pre-market approval (PMA) from the US Food and Drug Administration (FDA), setting the stage for US commercialisation of its gastro-oesophageal reflux disease (GORD) treatment.
The Lichtenstein-based company’s RefluxStop is an implantable, single-use device used in the laparoscopic treatment of GORD. Implanted near the left side of the oesophagus above the lower oesophageal sphincter, the device aims to correct oesophageal anatomy to form an anti-reflux barrier to prevent stomach acid flowing back. The device received a European CE mark in 2018.
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Implantica’s PMA was supported by the company’s submission of three evidentiary modules, the first of which was submitted to the FDA in March 2024.
The first module demonstrated that after one year of device implantation, RefluxStop resulted in an average 86% improvement in the GERD Health-Related Quality of Life (GERD-HRQL) score across 50 enrolled patients (NCT02759094). At the one-year follow up, only one out of 50 patients took regular daily PPIs due to improper device placement of the device. Meanwhile, no or only minimal occasional episodes of regurgitation occurred in 97.8% of evaluable patients.
RefluxStop’s PMA was also supported by Implantica’s five-year follow-up data of patients fitted with the device. Published in July 2025, the data reflected median total GERD-HRQL score improvements of 90% from baseline in 44 evaluable patients.
With the PMA in hand, Implantica’s CEO, Dr Peter Forsell, shared that RefluxStop’s US rollout will initially target select centres and reflux surgeons, with training included toto establish the GORD treatment with a “solid commercial foundation for sustainable long-term growth”.
Forsell continued: “We enter the US market from a position of strength, with a substantially more mature clinical and commercial foundation than is typical for a newly approved medical device.
“RefluxStop already has several years of commercial experience in Europe, close to 1,800 patients treated, more than 60 centres of excellence across nine European countries and published five-year clinical outcomes. Combined with our longstanding scientific engagement with many leading US surgeons and experts, we believe this provides a strong foundation to launch and scale RefluxStop in the US market.”
Research indicates that exists a GORD prevalence of up to 28% in North America, with common symptoms of the disease including acid reflux, bloating, and severe heartburn. RefluxStop is set to join other GORD treatment devices on the US market that are designed to repair or reinforce a weak lower oesophageal sphincter (LOS). These include Johnson and Johnson’s (J&J) LINX reflux management system, a widely used implantable device comprised of a flexible ring of small magnets placed around the LOS to keep it closed to prevent reflux.
