Implantica announces RefluxStop™ pivotal 4-year study results published in the prestigious journal Surgical Endoscopy
Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announces excellent long-term safety and clinical 4-year outcomes with the RefluxStop device (in the prospective multi-center CE study), which have recently been published in the prestigious journal, Surgical Endoscopy, an official journal of SAGES (American Gastrointestinal and Endoscopic Surgeons) and EAES (European Association For Endoscopic Surgery), entitled “Treating acid reflux without compressing the food passageway”.
Results from the study confirm that 4-year outcomes mirror the excellent 1- and 3-year outcomes reported previously. These results further validate and reinforce the consistency and long-term safety and efficacy of RefluxStop™ in treating gastroesophageal reflux disease (GERD). The study represents continued reporting on the cohort of 50 patients who were part of the CE Mark study.
At 4-year follow-up, patients experienced 90% improvement in GERD Health-Related Quality of Life (GERD-HRQL questionnaire) score, with no patients requiring daily medical therapy for acid reflux. 46/47 patients had no swallowing problems (dysphagia) at follow-up compared to 11 cases of mixed severity of dysphagia before surgery, which is one of the most common complications with standard of care procedures usually reaching about 30% at 5-year follow-up. No patient was dissatisfied because of acid reflux, as verified by normal 24-hour pH monitoring in the lower esophagus. Furthermore, the complications have been very limited with no device-related adverse events, no device deficiencies, no device explants, no device migrations/erosion, or no esophageal dilatations during the entire study.
Implantica Founder and CEO, Dr. Peter Forsell says, “We are truly inspired and encouraged to see these outstanding long-term results demonstrating sustained positive outcomes for GERD patients 4 years after undergoing the RefluxStop™ procedure. RefluxStop’s™ dynamic mechanism of action, allowing it to resolve GERD without encircling the food passageway, provides the much necessary holistic approach to treat this burdensome, complex disease.” Dr. Forsell goes on to say, “GERD impacts one billion people globally and over time can progress to more serious diseases like Barrett’s esophagus (precancerous changes) and esophageal cancer. With >35 leading hospitals in Europe performing the RefluxStop procedure, we are proud to offer this disruptive treatment to the millions of patients who need help urgently.”
Link to the 4-year publication: https://link.springer.com/article/10.1007/s00464-024-11114-0
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 August 20, 2024, 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 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 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.
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