RefluxStop helps reconstruct all three components of the anti-reflux barrier. Image credit: Shutterstock / Kmpzzz.

Implantica has unveiled positive two-year results for its RefluxStop device, an implant designed to manage gastro-oesophageal reflux disease (GORD).

Results from the study, which were presented at the Association of Upper Gastrointestinal Surgery (AUGIS) of Great Britain and Ireland 2024 Conference, demonstrate a 90.9% improvement in quality of life for patients living with the condition.

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The study was conducted in Germany and involved 158 patients with GORD. This condition is characterised by the repeated backflow of stomach acid into the oesophagus, causing various health issues that impact the daily lives of patients. These include heartburn, bad breath, and nausea, amongst others.

Lichtenstein-headquartered Implantica said that 96.4% of patients in the retrospective analysis discontinued regular proton pump inhibitor (PPI) medication – the standard of care for GORD.  There was also a 90.9% improvement in GERD-HRQL quality of life score, although Implantica stated that many of the patients had difficult-to-treat conditions such as large hiatal hernias, active esophagitis, and precancerous changes. These conditions, among others, can increase the risk of developing GORD.

One of the study’s authors, Dr Thorsten Lehmann said: “This paper shows that RefluxStop could allow me to offer more patients with large hiatal hernia the durable benefits of a surgical treatment for GORD.”

Johnson & Johnson MedTech’s Linx reflux management system, which received CE marking in 2008 and FDA approval four years later, is one of the current technologies on the market. The system consists of magnetic titanium beads connected with titanium wires that form a ring shape. The device is surgically implanted around the lower end of the oesophagus.

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However, unlike current approaches that rely on encircling the oesophagus, RefluxStop helps reconstruct all three components of the anti-reflux barrier. Upon implantation near the left side of the oesophagus above the lower oesophageal sphincter, the device restores and supports the natural anatomy in the area, reducing back-entry of acid.

RefluxStop received CE marking in August 2018, with the company now eyeing US Food and Drug Administration (FDA) approval.

Implantica’s CEO Dr Peter Forsell said the results are “reassuring that we are on the right path to bring this unique solution to patients as quickly as possible”.

The data adds to previous results published in Nature journal Scientific Reports in July, which demonstrated the device improved or completely resolved symptoms in 90% of patients with ineffective oesophageal motility.