Medtech company Implantica AG (XSTO: IMP A SDBB) on Wednesday announced the finalisation of its five-year CE mark study results for the RefluxStop device, designed to treat acid reflux, a condition affecting approximately one billion people globally. This milestone precedes the Module 2 submission of the premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA).

The upcoming Module 2, slated for submission this autumn, will include clinical and usability data, as well as findings from a Human Factors Validation Study conducted with 16 foregut/reflux surgeons in Chicago. Responses to FDA feedback from Module 1 will accompany this submission, ensuring compliance with rigorous FDA standards.

Preliminary results from the CE mark study are promising. Contrast swallow x-rays at five years show the RefluxStop device functioning correctly, with no dislocations, migrations or re-herniations. Additionally, 24-hour pH monitoring indicates high satisfaction among participants, with only one subject reporting a failed pH test. In contrast, a competitor's FDA trial reported a 42% failure rate in similar tests at one year.

RefluxStop distinguishes itself by addressing the underlying causes of gastroesophageal reflux disease (GORD) without applying pressure to the esophagus. This innovative approach aims to restore the natural function of the lower esophageal sphincter, potentially revolutionising anti-reflux surgery.

Implantica is committed to integrating advanced technology into medical solutions and has developed a diverse, patent-protected pipeline, including an eHealth platform for monitoring health parameters and a wireless energising platform for powering implants.