Implantica's RefluxStop® gains outstanding feedback at 2024 American Foregut Society meeting

1 November 2024
In VADUZ, Liechtenstein, on October 10, 2024, Implantica AG (publ.), a leading medtech company, announced significant interest from numerous U.S. doctors eagerly anticipating the launch of RefluxStop®, pending FDA approval. This interest is driven by robust clinical results from a five-year CE-study and consistent real-world outcomes from various centers. Over 600 leading anti-reflux surgeons, gastroenterologists, and specialists gathered at the American Foregut Society (AFS) Annual Meeting in Colorado, where RefluxStop® was a focal point of discussion.

Implantica is actively pursuing FDA approval for RefluxStop®, with the second of three PMA modules expected to be filed soon. The AFS meeting featured an in-depth panel discussion on RefluxStop® that included prominent U.S. surgeons and gastroenterologists, moderated by Dr. John Lipham, Chief of the Division of Upper GI and General Surgery and a professor at the Keck School of Medicine of the University of Southern California.

During the event, Dr. Lipham presented the five-year long-term outcomes data from the CE mark study, reinforcing previously published one-year and four-year results. These findings are consistent with real-world data from Europe, including recent safety and quality-of-life outcomes from over 200 patients in Switzerland and Germany. Dr. Lipham noted that RefluxStop's mechanism closely aligns with the Anti-Reflux Barrier (ARB) white paper released by AFS in November 2022, highlighting its unique approach compared to traditional methods. He expressed hope that RefluxStop® would soon be available to U.S. patients, subject to FDA approval.

Dr. Felice Schnoll-Sussman of Weill Cornell Medicine and AFS President provided insights from a gastroenterologist's viewpoint, expressing optimism about the long-term outcomes post-RefluxStop® procedure. She emphasized its potential as a solution for patients who might not be suitable for traditional surgical options, owing to its non-encircling design that reduces post-surgical side effects.

Implantica's Founder and CEO, Dr. Peter Forsell, expressed enthusiasm about the positive reception at the 2024 AFS meeting. He underscored the urgent need for innovative GERD treatments in the U.S., where around 20% of adults suffer from the condition. Dr. Forsell is confident that RefluxStop® will address a significant treatment gap in GERD management for millions of patients upon its U.S. launch, pending FDA approval.

The panel also included experts such as Dr. Reginald Bell, past-president of AFS; Prof. Dr. Peter Kahrilas from Northwestern University; Dr. Tripp Buckley from the University of Texas at Austin; Dr. Christy Dunst from The Oregon Clinic; Prof. Dr. Sebastian F. Schoppmann from the Medical University of Vienna; Prof. Dr. Sheraz Markar from Oxford University; and Dr. Moustafa Elshafei from Nordwest Hospital Frankfurt.

RefluxStop® is an innovative anti-reflux treatment distinct from traditional surgical methods. Unlike standard procedures that involve encircling the food passageway, often leading to side effects such as swallowing difficulties and inability to belch or vomit, RefluxStop® treats acid reflux without encircling the esophagus. It restores the lower esophageal sphincter to its original position, addressing all three components of the anti-reflux barrier.

Implantica, listed on Nasdaq First North Premier Growth Market, is committed to integrating advanced technology into the body. RefluxStop® is their flagship product, showing promising results in clinical trials. Additionally, Implantica focuses on eHealth, developing a range of patent-protected products, including an eHealth platform for monitoring health parameters and a wireless energizing platform for remote-controlled implants.

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