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Implantica AG (publ), a leading medtech company pioneering advanced implantable medical technologies, announced the second peer-reviewed publication of the remarkable 5-year outcomes from its CE mark clinical study of RefluxStop, a revolutionary device for the treatment of acid reflux—a condition affecting over 1 billion people worldwide.
The newly released publication focuses on long-term safety and effectiveness outcomes and complements the earlier 5-year report on food passageway-related outcomes. Both studies were published in the prestigious journal Surgical Endoscopy, jointly produced by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the European Association for Endoscopic Surgery (EAES).
The second publication, titled “Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: A prospective multicenter trial of safety and effectiveness,” provides the ultimate validation of RefluxStop’s consistent and outstanding clinical performance. Key highlights include:
- 97.9% of patients were free from proton pump inhibitor (PPI) medication use at 5 years, compared to 100% of patients taking PPIs pre-RefluxStop surgery.
- No device-related adverse events reported over the entire 5-year study period.
- Quality of life (GERD-HRQL scores) improved by a median of 90% (IQR), p<0.001.
- Acid exposure time in lower essophagus (24h pH monitoring), the only objective acid reflux measure, improved by 90.4%, p<0.001.
Dr. med. Joerg Zehetner of Klinik Beau-Site, Bern, Switzerland, who presented the study’s findings at the SAGES Scientific Conference in California, says: “RefluxStop has demonstrated truly stellar results that significantly improve the quality of life for GERD patients. As a surgeon who has treated thousands of patients in Switzerland from all over the world, the safety profile is paramount to me—and this study confirms RefluxStop as the safest and most effective surgical option for acid reflux sufferers available today. Over five years, there were no complications such as reherniations, migrations, or dislocations—confirmed via contrast-swallow imaging.”
Dr. Zehetner further noted the superior patient experience: “It is very encouraging to see that RefluxStop has maintained its crucial anatomical position over time, resulting in excellent sustained long-term patient outcomes. Importantly, RefluxStop uniquely restores the body’s natural anti-reflux barrier—offering unmatched long-term outcomes and safety as shown in this study. Also, postoperative swallowing difficulties were virtually eliminated—no patients required esophageal dilatation during the study, offering a major advantage compared to traditional GERD surgeries.”
Dr. Peter Forsell, founder and CEO of Implantica, added: “These 5-year results confirm RefluxStop’s strong potential to redefine the standard of care in GERD surgery. With nearly 50 RefluxStop Centers of Excellence established across Europe, Implantica is rapidly growing its clinical and commercial infrastructure to support broader adoption. The company is now preparing for its US market launch, pending FDA approval. As we approach the US launch, we believe RefluxStop is uniquely positioned to become the gold standard in surgical GERD treatment—offering superior patient outcomes, safety, and long-term cost-effectiveness.
With FDA approval pending, global expansion underway, and increasing clinical momentum, we are focused on unlocking significant value for patients, providers, and shareholders alike.”
RefluxStop is a new innovative treatment that has the potential to spur a paradigm shift in anti-reflux surgery. It’s unique mechanism of action differentiates it from standard of care and current surgical solutions. Longer established surgical options for GORD involve encircling the food passageway to support the lower esophageal sphincter’s closing mechanism and are commonly associated with side effects such as swallowing difficulties, pain when swallowing and inability to belch and/or vomit.
In contrast, the RefluxStop device treats the cause of acid reflux without encircling and putting pressure on the food passageway. It restores and maintains the lower esophageal sphincter in its original, natural position.
The RefluxStop mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux.
Implantica is a MedTech group dedicated to bringing advanced technology into the body. Implantica’s lead product, RefluxStop, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results.
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