Latest news with #RefluxStop
Yahoo
4 days ago
- Business
- Yahoo
Implantica announces that UK NICE has published positive recommendations for the RefluxStop™ procedure in the NHS public hospitals
VADUZ, Liechtenstein, June 4, 2025 /PRNewswire/ -- Implantica AG (publ.), providing the unique device RefluxStop™ for the treatment of acid reflux, announces that the world-renowned National Institute for Healthcare Excellence (NICE) payer advisory agency for NHS public hospitals in the UK has published positive Interventional Procedures Guidance (IPG) recommendations on the RefluxStop™ procedure, wherein GORD/GERD patients with Ineffective Oesophageal Motility (IOM/IEM) are allowed to be operated with RefluxStop procedure in the public healthcare system, following its guidelines and special arrangements. In the treatment field of acid reflux up to 40-50%1 of the 1 billion sufferers have IOM/IEM. Therefore, NICE IPG recommendations could transform the lives of millions of patients in the UK and worldwide, given NICE's global influence on health policy development. The IOM/IEM condition is largely untreatable with traditional standard of care. Mr. Ahmed Ahmed, Consultant Surgeon at St. Mary's Hospital, Imperial College NHS Health Trust says, "The positive NICE guidance for use of RefluxStop is a major victory for GORD patients. This decision empowers NHS Anti-Reflux Surgeons to continue delivering cutting-edge care while contributing to the growing body of evidence supporting RefluxStop procedure as a transformative solution for GORD. My patients have heard about RefluxStop procedure as they seek a solution for GORD and ask for it specifically by name. It will be very reassuring for GORD patients to have this supporting evidence-based guidance." Another leading surgeon in the NHS public hospitals, Mr. Fergus Noble, Consultant Surgeon at University Hospital Southampton NHS Foundation Trust, adds, "NICE's new guidelines are crucial for the broader use of a new procedure in the NHS. I'm proud to be a part of this important step forward in expanding the landscape of anti-reflux surgical options for patients with GORD and IOM. Unlike traditional anti-reflux surgeries, the RefluxStop procedure does not rely on encircling the oesophagus, making the durable benefits of a surgical treatment for GORD available to desperate patients who have struggled with the painful symptoms of combined GORD and IOM with poor motility for years." Inventor of the RefluxStop™ procedure, CEO and Founder of Implantica, Dr. Peter Forsell says, "We would like to thank NICE for their independent multidisciplinary assessment of the RefluxStop procedure and invaluable efforts to recognize the excellent safety and efficacy of the innovative RefluxStop™ procedure for use in NHS public hospitals. This recommendation for GORD/GERD patients with IOM marks the start of a global paradigm shift in the surgical treatment of acid reflux, with the NHS UK taking the lead." 1. Shih-Chi Ho et al., Ineffective esophageal motility is a primary motility disorder in gastroesophageal reflux disease. Digestive Diseases and Sciences, 2002. 47(3): 652-6 For further information, please contact:Nicole Pehrsson, Chief Corporate Affairs OfficerTelephone (CH): +41 (0)79 335 09 Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, info@ The information was sent for publication, through the agency of the contact person set out above, on June 04, 2025, at 08:00 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 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 GORD 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. Newsroomhttps:// Communityhttps:// Media Contact:Implantica AGJuanita Eberhart, VP Marketing & AdvocacyM: +1 This information was brought to you by Cision The following files are available for download: Implantica announces that UK NICE has published positive recommendations for the RefluxStop™ procedure in the NHS public Hospitals logo transparent 1 8 ReluxStop Product View original content:
Yahoo
27-05-2025
- Health
- Yahoo
Implantica's RefluxStop™ stimulates intensive dialogue at DDW, the world's largest Digestive Disease conference, held in the U.S.
VADUZ, Liechtenstein, May 27, 2025 /PRNewswire/ -- Implantica AG (publ.) reports successful pre-launch activities in the U.S., pending FDA approval, with European real-world clinical evidence generating much interest from U.S. surgeons. Several presentations on RefuxStop™ were held at DDW, an impressive hub for discussing the latest innovations and clinical data in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Over 13,000 leading surgeons, gastroenterologists (GIs), academics, and researchers recently gathered in San Diego, California for the 2025 conference. Dr. med. Zehetner says, "The curiosity and interest were palpable as more and more surgeons and GIs throughout DDW learned about the unique mechanism of action and the advantages of the RefluxStop procedure. It's an honor to be able to share my real-world RefluxStop knowledge and clinical outcomes with the top experts and leaders in this treatment field, all in attendance at DDW." Performing resurgery using RefluxStop™ on failed standard of care procedures was a topic of a study on the combined results from Dr. Lehmann, Germany, and from Dr. Zehetner (Prof. USC), Switzerland, "Feasability and technique of conversion to RefluxStop from previous anti-reflux surgery in GERD patients". The conclusion was that RefluxStop™ provides successful outcomes when used for reoperations on the most common standard surgical methods. Dr. Zehetner also presented his excellent results in a study entitled, "Laparoscopic anti-reflux surgery outcomes at 12 months in the first 100 patients to undergo RefluxStop procedure in a single institution in Switzerland." RefluxStop™ was favorably discussed during the "Technologies and Procedural Innovation" session presentation by Dr. Reginald Bell, the leading US surgeon and past President of the American Foregut Society (AFS). All sessions boasted high attendance driven by high interest in the unique approach and the impressive European clinical data outcomes of the RefluxStop™ procedure. Implantica CEO and founder, Dr. Peter Forsell, adds, "I'm grateful to all our independent surgeons who go through great efforts to publish their real-world data to advance the field of GERD management and improve patient care. The RefluxStop™ procedure's unique mechanism of action eliminates many of the uncomfortable post-surgical side effects typically associated with anti-reflux procedures. We strongly believe RefluxStop™ is uniquely positioned to have a lasting impact on the anti-reflux surgery landscape for decades to come." For further information, please contact: Nicole Pehrsson, Chief Corporate Affairs OfficerTelephone (CH): +41 (0)79 335 09 Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, info@ The information was sent for publication, through the agency of the contact person set out above, on 27. May 2025, at 08:00 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 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 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. Newsroom Community Media Contact: Implantica AG Juanita Eberhart, VP Marketing & Advocacy M: +1 925-381-4581 This information was brought to you by Cision The following files are available for download: Implantica’s RefluxStopâ'¢ stimulates intensive dialogue at DDW, the world’s largest Digestive Disease conference held in the U.S. logo transparent 1 8 ReluxStop Product View original content: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-02-2025
- Business
- Yahoo
Implantica announces positive feedback received from U.S. FDA of the RefluxStop™ PMA Module 2 submission
VADUZ, Liechtenstein, Feb. 13, 2025 /PRNewswire/ -- Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces that U.S. FDA has completed its review of the PMA Module 2 submission and provided its feedback, in which the company sees no barrier for responding. FDA has completed its review of the company's second modular submission of its PMA, which contained the Clinical Data, Usability Testing, and Labeling information supporting RefluxStop™. FDA has provided Implantica with its written feedback on the content submitted, all of which the company considers to be minor. A response strategy has been identified for the questions raised, and the company sees no impediment to the overall PMA approval process based on FDA's Module 2 feedback. Responses to the Module 2 feedback will be submitted in conjunction with the final Module 3 submission in the near term. Dr. Peter Forsell, Implantica's founder, CEO, and the inventor of RefluxStop, says, "We are thankful for FDA for their review of Module 2 and are pleased to receive their positive feedback on our submission thus far. Module 2 includes the results of the RefluxStop™ clinical study and is by far the most important module for this PMA from our perspective. The 5-year outcomes in conjunction with data reported in the literature are extremely positive and indicate that RefluxStop™ may revolutionize this treatment field. Implantica will, in the near term, submit the last component of our PMA application (Module 3) and work with FDA to bring RefluxStop™ to the U.S. market as soon as possible." For further information, please contact:Nicole Pehrsson, Chief Corporate Affairs OfficerTelephone (CH): +41 (0)79 335 09 Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, info@ The information was sent for publication, through the agency of the contact person set out above, on February 13, 2025, at 08:00 a.m. (CET). About ImplanticaImplantica 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 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 GORD 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. Newsroomhttps:// Communityhttps:// Media Contact:Implantica AGJuanita Eberhart, VP Marketing & AdvocacyM: +1 This information was brought to you by Cision The following files are available for download: Implantica announces positive feedback received from U.S. FDA of the RefluxStopâ'¢ PMA Module 2 submission logo transparent 1 8 REFLUXSTOP View original content:
