Medical technology company Implantica AG (Nasdaq First North Premier Growth Market: IMP A SDB) announced on Wednesday that the U.S. Food and Drug Administration has reviewed the final Module 3 of its Premarket Approval (PMA) submission for RefluxStop and provided favourable feedback, according to the company's assessment.

RefluxStop, already CE-marked, is designed to treat gastroesophageal reflux disease (GERD), which affects an estimated one billion people worldwide. Unlike conventional surgical options that apply pressure to the food passageway, the device restores the lower oesophageal sphincter to its natural position, aiming to eliminate reflux while reducing side effects such as swallowing difficulties and inability to belch.

Implantica, headquartered in Europe, is developing a pipeline of medtech and eHealth innovations supported by proprietary platforms for wireless energising of implants and remote monitoring from inside the body.