Frost & Sullivan recently assessed the European gastroesophageal reflux disease (GERD) treatment industry and, based on its findings, recognizes Implantica with the 2022 European Technology Innovation Leadership Award for its GERD therapy device. The company developed the RefluxStop device, a CE-marked, first-of-its-kind single-use sterile medical implant, for acid reflux treatment. The device prevents the regurgitation of stomach fluid into the esophagus and addresses the limitations of commonly used drug treatment, Proton Pump Inhibitors (PPIs) and current surgical methods for treating acid reflux disease. The RefluxStop device is placed outside of the top part of the stomach (fundus wall) during laparoscopic surgery, reconstructing the angle of His, an acute angle at the esophagogastric junction. Such reconstruction and the RefluxStop device restores and maintains the normal physiological situation and prevents the reflux of the stomach content into the esophagus.
According to a recently published global study in Nature medical journal, there are more than 1 Billion people suffering from reflux disease. The awareness of complications from PPI use is growing, and these complications are more dangerous than previously anticipated, leading to serious diseases and even death. GERD is among the top two most widespread chronic diseases in the world, impacting 17% of the EU and 19% of the US population with over six percent of the population over 400 million people having daily symptoms.
Implantica’s RefluxStop device blocks the movement of the lower esophageal sphincter into the thorax, eliminating the weakening of the lower esophageal sphincter due to pressure variations caused by the breathing process and thereby prevents acid reflux. As a result, the device addresses the root cause of the condition, eliminating GERD and enabling normal pH in the lower esophagus. Too low pH in lower esophagus is correlated not only to heartburn, but also to esophagitis and development of precancerous changes in the lower esophagus, so called Barrett’s esophagus, a precancerous condition caused by GERD that can lead to esophageal adenocarcinoma. Approximately 48,000 people die every year due to adenocarcinoma in the lower esophagus in the EU and US alone. Furthermore, reducing the use of PPIs after the RefluxStop device procedure curtails annual healthcare costs and indirect costs based on GERD-associated decreased work productivity. The American College of Gastroenterology reported that GERD symptoms cost the US nearly $2 billion per week in lost productivity.
Neeraj Nitin Jadhav, an Industry Analyst with Frost & Sullivan, stated that “RefluxStop device placement on the upper part of the stomach keeps the esophageal sphincter permanently in the abdomen, below the diaphragm and does not encircle and put pressure on the food passageway. This prevents the development of complications associated with existing GERD surgical interventions and devices as it restores the body’s natural anatomy.”
Implantica’s RefluxStop device consists of 5 rounded parts to enable optimal flexibility in treating acid reflux, without affecting the functioning of the stomach in turn reducing the risk of post-procedural complications for patients. The device’s solid medical-grade silicone makes it durable, allowing it to last for the patient’s entire lifespan and preventing frequent implant replacement. Subsequently, the device improves patient safety and lowers the financial burden on the patient and healthcare system.
The RefluxStop device is safe and effective in maintaining normal pH in the lower esophagus, improving quality of life, reducing the prevalence of gas bloating and dysphagia, and eliminating the daily use of PPIs and serious device-related adverse effects. The CE-marked device’s promising results and Implantica’s focus on partnering with key opinion leaders, including highly skilled surgeons and reputed GERD centers of excellence in Germany, Austria, Switzerland and the UK, have spurred its adoption among patients. Implantica’s partnerships with prominent anti-reflux centers, hospitals, and healthcare providers in various countries increase the device’s geographical footprint.
“These strategic partnerships unlock the full business potential of RefluxStop and facilitate timely market access and robust growth in company revenues,” said Jadhav. “Implantica’s medical implant successfully treats GERD without affecting the food passageway, in turn improving patients’ health outcomes and quality of life.”
Each year, Frost & Sullivan presents this award to the company that has developed a product with innovative features and functionality that is gaining rapid acceptance in the market. The award recognizes the quality of the solution and the customer value enhancements it enables.
Frost & Sullivan Best Practices Awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.
Implantica (implantica.com) 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 energising platform designed to power remote controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market).
Juanita Eberhart, Senior Director of Marketing
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