Medical technology company Implantica AG (Nasdaq First North Premier Growth Market: IMP A SDB) reported on Wednesday that it is ramping up production of its RefluxStop device with 10,000 units manufactured in preparation for a US launch, pending FDA premarket approval (PMA).

The company is building inventory, infrastructure and specialist teams to accelerate commercialisation and secure a rapid, scalable rollout in the US and other global markets once regulatory approvals are granted. By investing in early production, Implantica aims to avoid supply delays typically faced by medtech firms during initial market entry.

RefluxStop, already CE-marked in Europe, offers a novel treatment for gastroesophageal reflux disease (GERD), a condition affecting more than one billion people worldwide. Unlike traditional surgical methods that encircle the esophagus, the device restores the natural position of the lower esophageal sphincter without applying pressure, reducing common side effects such as swallowing difficulties.

Implantica is also advancing a broader pipeline based on its eHealth and wireless energising platforms, designed to enable remote-controlled implants and real-time health monitoring inside the body.