Implantica Touts Positive Study Results for its RefluxStop Device

Implantica AG’s anti-reflux device can help significantly improve, or in some cases, resolve acid reflux symptoms, according to recently released study results. 

Implantica conducted the investigator-initiated independent multicenter trial at the General Hospital of the Medical University of Vienna, Austria; and King Edward VII Hospital in London, United Kingdom; from 2021 through 2023. All 40 patients had Ineffective Esophageal Motility (IEM) preoperatively, a notoriously difficult-to-treat subgroup of GERD patients.
 
Three months after the RefluxStop procedure, symptoms completely resolved or improved in 90% of the patients, PPI consumption was reduced by 84% and Quality of Life GERD-HRQL score was reduced from 32.8 to 6.6, an improvement of 80%, with limited side effects.

“It’s exciting to conduct the first real-world multicenter study assessing the safety and efficacy of the RefluxStop procedure,” commented Prof. Dr. Sebastian Schoppmann of the Medical University of Vienna. “We found patients treated with RefluxStop experienced substantial improvements in quality of life and reflux symptoms with minimal safety issues despite all having ineffective esophageal motility. IEM is a well-known group of patients without any effective treatment options. Given RefluxStop’s great promising early results showing significant improvement in patient outcomes in GERD, we are now planning additional studies to validate our findings further and hopefully establish this as an effective treatment option to help the widely underserved GERD patient population.”

Patients with ineffective esophageal motility (IEM) have a weaker transportation of food down the esophagus and, therefore, often have swallowing difficulties. These patients are usually not recommended for surgery with standard of care surgical methods because they encircle and put pressure on the food passageway causing swallowing problems to worsen. This patient group comprises about one-third of the acid reflux sufferers that currently have no well working treatments.

RefluxStop’s unique mechanism of action differentiates it from standard of care and current surgical solutions, according to Implantica. 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.

“It is exciting to see how well RefluxStop treats IEM patients with limited side effects since it does not encircle the food passageway like existing standard of care surgical treatments,” Implantica Founder/CEO Peter Forsell, the RefluxStop inventor, said. “Since launch several hundred patients with IEM have been operated with RefluxStop and the results have been excellent. We are very pleased to see these results published in Scientific Reports, which is a hallmark of high-quality research work, and would like to thank Prof. Schoppmann and Dr. Boyle for their dedicated work. It is satisfying to see the RefluxStop procedure used for GERD patients with esophageal motility disorders given that historically these patients were largely excluded from the existing anti-reflux surgical treatments. RefluxStop™ has established itself as a great hope for these difficult-to-treat patients as well as millions of other GERD patients who would benefit from the RefluxStop procedure with its unique mechanism of action.”
 
The independent study, “Multicentric short term and safety study of ineffective esophageal motility (IEM) patients treated with RefluxStop device” was published in Nature Scientific Reports.
 
Implantica is a medtech group whose lead product, RefluxStop, is a CE-marked implant for preventing gastroesophageal reflux. Implantica also focuses on eHealth inside the body and has developed a 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; 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.