Implantica receives CE Mark Approval for RefluxStop(TM), a potential Paradigm shift in the Treatment for Acid reflux
Implantica, a privately held medtech company, announced today that it has received CE Mark approval for RefluxStop(TM), a novel approach to treat acid reflux.
The CEO of Implantica MediSwiss AG, Dr. Peter Forsell, states:
"We are pleased to have accomplished this important milestone for all of those suffering from acid reflux. Based on the successful clinical trial results, Implantica's RefluxStop(TM) may represent a paradigm shift in the treatment of gastroesophageal reflux disease (GERD) as it more effectively treats acid reflux and does so with reduced side effects since it does not compress the food passageway. Current standard surgical acid reflux treatments are plagued with complications as they compress the food passageway, often resulting in swallowing difficulties and the inability to burp or vomit."
A literature review and meta-analysis has been performed comparing Nissen fundoplication, the current "gold standard" surgical treatment for acid reflux, with the results from the RefluxStopTM six month clinical investigation for CE mark, which showed that the new method of treating acid reflux works with both better treatment results and fewer side effects.
CE Mark approval has been granted August 8, 2018, on the strength of a multi-center clinical investigation in which the safety and effectiveness of the device in patients was demonstrated. The approval enables the company to market and sell RefluxStop(TM) in member countries of the European Economic Area and Switzerland.
Acid reflux is a treatment field with approximately 375 million sufferers worldwide. Up to 15% of sufferers develop precancerous changes in their lower esophagus (Barrett's esophagus) due to acids repeatedly damaging esophageal tissue. It has been shown that drug therapy does not remove the cancer risk, and long-term drug therapy is associated with complications in many patients.
For further information, please contact:
Implantica Management AG
Email: [email protected]
Contact person: Nicole Pehrsson
Implantica is a privately held medtech company dedicated to bringing advanced technology into the body. Implantica's first product, RefluxStop(TM), will potentially create a paradigm shift in anti-reflux surgery as supported by the successful clinical trial results. Implantica's wireless energizing platform, developed for eHealth Smart Medical Implants (prototype not yet CE marked), is designed to make previously impracticable medical implants possible with the ability to power remote controlled implants wirelessly through intact skin. In addition, Implantica has developed an eHealth platform (prototype not yet CE marked) to be initially used in combination with upcoming eHealth smart implants and later as a stand-alone eHealth monitoring device, e-InVivo(TM), which shall collect data from inside the body and transfer the data to external devices or directly to the caregiver. e-InVivo(TM) is designed to monitor a broad range of health parameters and provide diagnostic information with early detection of diseases as well as control treatment from inside the body.