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Implantica's Landmark Study on RefluxStop®

Implantica AG, a leader in the medical technology sector, has unveiled its latest findings on the RefluxStop® device, aimed at treating gastroesophageal reflux disease (GERD). This innovative study, published in Nature's Scientific Reports, examined the outcomes of 602 patients treated across 22 European centers, showcasing the device's significant safety and efficacy in real-world scenarios.

Overview of the Study

The groundbreaking research titled "Safety Outcomes in 602 GERD Patients Treated by RefluxStop: A Multi-Center Real-World Study from 22 Centers Across Six European Countries," is the most extensive assessment of RefluxStop®'s long-term safety to date. The study included patient follow-ups of up to 6.75 years, reinforcing the device's potential to revolutionize GERD treatment.

Key findings from the study include:

• - Over 98% of patients experienced no serious complications that necessitated reoperation.
• - All adverse events reported were resolved satisfactorily across all patients.
• - The primary cause for reoperation, which was 1.33% of total patients, was diagnosed as a recurrence of hiatal hernia—a common complication observed in various anti-reflux surgical interventions.
• - Notably, the recurrence rates of hiatal hernia in standard surgical practices are nearly ten times higher than those observed in this study.

Expert Insights

Professor Sebastian Schoppmann, who led the study and is affiliated with the Medical University of Vienna, presented these findings at the prestigious American Foregut Society Meeting in 2025. His insights were met with enthusiasm, highlighting the interest in further exploring RefluxStop® in a U.S. market pending FDA approval.

Dr. Peter Forsell, the founder and CEO of Implantica, remarked on the significance of this research, pointing out that, "This comprehensive evaluation has the potential to change the landscape of GERD surgery. The findings reaffirm our belief in the safety profile of RefluxStop®, which could serve millions of patients awaiting effective treatment.” He emphasized that as the company approaches FDA approval, such real-world data becomes increasingly critical.

About RefluxStop®

The RefluxStop® device diverges from traditional anti-reflux operations, which generally involve constricting the esophagus to enhance the closure mechanism of the lower esophageal sphincter. This method often leads to complications such as swallowing difficulties and discomfort. Conversely, RefluxStop® addresses the root of acid reflux without placing pressure on the esophagus, maintaining its natural anatomy and function. This novel approach aims to preserve and restore the body's original physiological state, allowing for a more effective and safer treatment of GERD.

Implantica’s dedication to innovation in healthcare extends beyond RefluxStop®. The company continues to develop a range of advanced technologies, including an eHealth platform designed to monitor health parameters and manage treatment remotely.

As the sector eagerly awaits FDA approval for RefluxStop®, the outcomes from this study could set a new standard in the treatment of GERD worldwide. With over 1 billion people affected globally, these advancements represent hope for countless individuals seeking relief from acid reflux.

For more information on Implantica and their innovative solutions, visit www.implantica.com.