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Implantica Unveils Groundbreaking 5-Year Clinical Study Results for RefluxStop®

In a significant advancement for the treatment of acid reflux, Implantica AG has announced the publication of extraordinary results from a 5-year clinical study of their unique medical device, RefluxStop®. This innovative treatment, aimed at addressing gastroesophageal reflux disease (GERD), is set to change the landscape of surgical options for the estimated 1 billion people afflicted worldwide.

The study results, published in the highly esteemed journal, Surgical Endoscopy, reveal unprecedented long-term success rates. Conducted in multiple centers, the trial focused on patient outcomes related to food passageway after undergoing treatment with RefluxStop®. Notably, the findings indicate that:

• - 97.9% of participants reported no adverse events related to dysphagia (difficulty swallowing).
• - 97.9% experienced no adverse events concerning odynophagia (painful swallowing).
• - 95.7% of patients noted improvements or resolution regarding gas-bloating symptoms.
• - 100% maintained the ability to belch or vomit following the procedure.

Dr. Peter Forsell, the CEO and founder of Implantica, emphasized the significance of these results, highlighting a stark contrast with traditional surgical options such as Nissen fundoplication. Data from a literature review of this standard procedure illustrated that at five years, dysphagia affected 28.9%, gas-bloating was reported in 52.7%, and 39.8% of patients were unable to belch or vomit. These comparative statistics reinforce the belief that RefluxStop® could usher in a much-needed paradigm shift in acid reflux treatments.

A New Era for GERD Management

The clinical data lays the groundwork for an exciting upcoming phase in the U.S. market as FDA approval is on the horizon. Dr. Forsell expressed optimism about introducing RefluxStop® to millions of patients suffering from GERD in the United States, where an estimated 22-27% of the population is affected by this debilitating condition.

RefluxStop’s innovative design differentiates it from traditional treatments by avoiding the encircling technique that typically results in various side effects, including swallowing difficulties and the inability to belch. Instead, RefluxStop® restores the lower esophageal sphincter's natural function, offering patients a less invasive option with considerably fewer complications.

This groundbreaking study, titled Food Passageway-related Sequelae in the RefluxStop® Prospective Multicenter Trial: Patient-Centric Outcomes of Dysphagia, Odynophagia, Gas-Bloating, and Inability to Belch and/or Vomit at 5 years, was presented at the SAGES 2025 conference in California by Dr. Jörg Zehetner from Kinik Beau-Site in Bern, Switzerland. The presentation was met with enthusiasm, reflecting the medical community's interest in new developments in GERD treatment.

Conclusion

Implantica is paving the way not only for surgical advancements but for a holistic approach to managing acid reflux, aligning with their vision of integrating advanced technology into healthcare. As they prepare for potential U.S. market entry, the implications of their findings will likely resonate throughout the medical community and offer new hope to millions affected by GERD worldwide.

For more detailed information on RefluxStop® and its clinical studies, visit Implantica's official website. With continued research and innovation, Implantica could redefine how the medical sector approaches one of the most common gastrointestinal disorders today.