Implantica announces excellent data from an independent study of 158 RefluxStop™ patients from two centers in Germany - presented at the AUGIS meeting in UK
VADUZ, Liechtenstein, Sept. 18, 2024 /PRNewswire/ -- Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, reports that the study "Pooled two-year results of the novel RefluxStop implantable device in management of gastroesophageal reflux disease in Germany: Retrospective analysis," shows over 90% improvement in GERD quality-of-life scores in patients 2 years after the procedure.
The study was recently presented at the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS) 2024 Conference. AUGIS promotes high-quality training programs, such as this Scientific Meeting, for the surgical treatment of gastrointestinal disorders in the UK.
This German study included 158 patients and reported impressive two-year follow-up effectiveness and safety outcomes with patients achieving significant improvement in their symptoms, and as a result, 96.4% of patients discontinued their regular PPI medication. An impressive 90.9% improvement in GERD-HRQL quality of life score was achieved although many of the patients had difficult-to-treat conditions, such as 22% had large hiatal hernia (over 3 cm), 44% active esophagitis and 10% precancerous changes (Barrett's esophagus).
Data for the study came from top German anti-reflux surgeons; Dr. med. Moustafa Elshafei, study lead at Krankenhaus Nordwest, Frankfurt and Dr. med. Thorsten Lehmann, study lead at Klinikum Friedrichshafen, Friedrichshafen.
Dr. med. Elshafei, who presented the study at the AUGIS meeting says, "We are delighted by the outcomes of this new procedure and the significant interest in RefluxStop at AUGIS. It is great to see my UK peers so open and willing to embrace this cutting-edge technology and help drive innovation in the surgical treatment of GERD."
Dr. med. Lehmann says, "This paper shows that RefluxStop could allow me to offer more patients with large hiatal hernia the durable benefits of a surgical treatment for GERD. I am thrilled to see such promising results in close to 200 patients I have treated over the past three years and what it could mean for many more patients who were not eligible for the traditional anti-reflux surgeries in the past."
Founder and CEO of Implantica, Dr. Peter Forsell adds, "I want to extend my gratitude to Dr. med. Elshafei and Dr. med. Lehmann, two independent surgeons, for their invaluable efforts in sharing RefluxStop™ results that are indeed impressive and reassuring that we are on the right path to bring this unique solution to patients as quickly as possible. In the UK alone, GERD impacts an estimated 9.5 million people¹. We are thrilled to see rapidly growing interest from many NHS centers that we expect to start offering RefluxStop™ treatment soon."
Read the abstract on page 3:
- Nirwan JS, Hasan SS, Babar ZU, Conway BR, Ghori MU. Global Prevalence and Risk Factors of Gastro-oesophageal Reflux Disease (GORD): Systematic Review with Meta-analysis. Sci Rep. 2020 Apr 2;10(1):5814. doi: 10.1038/s41598-020-62795-1. PMID: 32242117; PMCID: PMC7118109
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 September 18, 2024, at 08:30 a.m. (CEST).
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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Media Contact:
Implantica AG
Juanita Eberhart, VP Marketing & Advocacy
M: +1 925-381-4581
juanita.eberhart@implantica.com
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