VADUZ, Liechtenstein, Oct. 10, 2024 /PRNewswire/ -- Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, is pleased to report an impressive level of support from a large number of U.S. doctors who are interested to start with RefluxStop®* after launch, pending FDA approval, driven by the very solid clinical results from the 5-year CE-study and real world outcomes from multiple centers that mirror these excellent results.
Over 600 of the world's top anti-reflux surgeons, gastroenterologists, and other experts met to discuss treatment innovations in foregut diseases at the American Foregut Society (AFS) Annual Meeting in Colorado, where RefluxStop® dominated the discussions.
Implantica is actively working on the FDA approval process to bring RefluxStop® to the US market with the PMA filing of the second module (of three) expected in the near-term. The RefluxStop® procedure was at the forefront of the new innovation discussions at the AFS meeting.
The meeting was revved up with a power-packed panel about RefluxStop including the leading US Surgeons and Gastroenterologists, moderated by Dr. John Lipham, Chief of the Division of Upper GI and General Surgery and Professor at the Keck School of Medicine of the University of Southern California and AFS Past President. Dr. Lipham opened the meeting by announcing the 5-year long-term outcomes data from the CE mark study that further reinforces the already published 1-year and 4-year results that are largely consistent with the published real-world data from Europe, including the latest safety and quality-of-life outcomes from over 200 patients in Switzerland and Germany, presented at the AFS meeting.
Dr. Lipham shared the following: "RefluxStop's CE mark data and reported real-world data show highly consistent outcomes, which is quite impressive. It is also very interesting to see how closely the RefluxStop procedure's mechanism of action matches the white paper on the ARB released by AFS in November 2022. Seeing the impact of treating all three aspects of the anti-reflux barrier to resolve acid reflux is confirming much of our learning experience. RefluxStop's unique mechanism of action is what truly differentiates it from the traditional methods. I hope we will be able to offer this promising procedure to US patients in the near future, pending US FDA approval."
Panelist Dr. Felice Schnoll-Sussman of Weill Cornell Medicine and President of AFS offered insights from a gastroenterologist's perspective, "I was encouraged to see such long-term outcomes after the RefluxStop® procedure. It could have the potential to be a great solution for many patients, including those that might not have qualified for traditional surgical options, as it does not encircle the food passageway. The fact that the current data shows significantly reduced undesirable post-surgical side effects is especially exciting."
Founder and CEO of Implantica, Dr. Peter Forsell, says, "It's truly humbling to see the amazing interest, energy, and excitement coming from the 2024 AFS meeting. It could not be clearer that there is an urgent need for an innovative surgical treatment to offer GERD patients in the US, where an estimated 20% of adults suffer from the disease. We are confident that RefluxStop® can help address this enormous treatment gap in GERD management for millions of patients when we launch in the US, pending FDA approval."
Additional Panelists included:
- Dr. med. Reginald Bell, Past-President and Chair, American Foregut Society, Colorado, US
- Prof. Dr. Peter Kahrilas, Gilbert H. Marquardt Professor of Medicine, Professor, Fienberg School of Medicine, Northwestern University, Chicago, US
- Dr. med. Tripp Buckley, Associate professor in the Department of Surgery and Perioperative Care and chief of the Division of Elective General Surgery, University of Texas at Austin Dell Medical School, Texas, US
- Dr. med. FSIE Christy Dunst, Esophageal Surgical Specialist, Center for Advanced Surgery, The Oregon Clinic, Portland, OR, US
- Prof. Dr. Sebastian F. Schoppmann, MD, FACS, Professor of Surgical Oncology, Medical University of Vienna, Upper-GI-Service, Department of General Surgery, Division of Visceral Surgery, Vienna, Austria
- Prof. Dr. Sheraz Markar, Professor of Upper Gastrointestinal Surgery & Director of the Surgical Interventional Trials Unit Nuffield Department of Surgical Sciences, Oxford University, UK
- Dr. med. Moustafa Elshafei, Senior Consultant Nordwest Hospital Frankfurt Department of Metabolic and Bariatric Surgery, Frankfurt, Germany
* Registered Trademark in US
For further information, please contact:
Nicole Pehrsson, Chief Corporate Affairs Officer
Telephone (CH): +41 (0)79 335 09 49
nicole.pehrsson@implantica.com
Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm.
The company's Certified Adviser is FNCA Sweden AB, info@fnca.se
The information was sent for publication, through the agency of the contact person set out above, on October 10, 2024, at 08:30 a.m. (CET).
About Implantica
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. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit www.implantica.com for further information.
About RefluxStop®
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 GERD involve encircling the food passageway to support the lower oesophageal 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 oesophageal 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.
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Implantica AG
Juanita Eberhart, VP Marketing & Advocacy
M: +1 925-381-4581
juanita.eberhart@implantica.com
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https://mb.cision.com/Main/19732/4049364/3046687.pdf | Implantica announces highly successful 2024 American Foregut Society meeting where RefluxStop® received remarkable pre-launch market feedback |
https://news.cision.com/implantica/i/afs-2024,c3341179 | AFS 2024 |
https://news.cision.com/implantica/i/logo-transparent-1-8,c3341178 | logo transparent 1 8 |
https://news.cision.com/implantica/i/reluxstop-product,c3341180 | ReluxStop Product |
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