Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease (GERD) treatment, RefluxStop.
The Liechtenstein-based company is seeking approval for RefluxStop through the US FDA’s premarket approval application (PMA) modular review programme. The PMA modular review allows companies to complete sections, called modules, at different times and the final confirmation is granted once the applicant completes all sections of the PMA. The programme also allows for ongoing review and feedback from the FDA as the modules are submitted.
Implantica has submitted the first module and plans to submit the next two modules in three-month intervals later this year. Following the news, the company’s stock was up by over 8.7% in trading today.
The company has also conducted a human factors validation study as part of the PMA process. The study recruited 16 US-based surgeons with varying levels of surgical experience to carry out the RefluxStop procedure. The study aims to demonstrate that the device can be implanted by surgeons without serious use errors or problems. The data will be evaluated by an independent third party before submission to the FDA.
RefluxStop is an implantable, non-active, single-use device used in the laparoscopic treatment of GERD. The device is implanted near the left side of the oesophagus above the lower oesophageal sphincter and aims to correct oesophageal anatomy to form an anti-reflux barrier, thereby, stopping acid reflux. The device received a CE mark in 2018.
After one year of the device implantations, RefluxStop demonstrated an average 86% improvement in the GERD Health-Related Quality of Life (GERD-HRQL) total score of the participants recruited in the device trial (NCT02759094). At one year follow up, only one out of the 50 participants took regular daily PPIs due to improper (too low) placement of the device, thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in seven subjects.
GERD is a common gastrointestinal disorder and affects 10-20% of the population. The symptoms include acid regurgitation and heartburn. Common treatment for GERD is medications including antacids, which can lose efficacy if used for long durations.
Apart from GERD treatment, multiple companies have also developed diagnostic devices for the indication. Laborie Medical Technologies has developed a wireless pH-capsule reflux testing system, dubbed alpHaONE. Diversatek Healthcare’s MiVu system tests mucosal integrity for rapid diagnosis of GERD, eosinophilic oesophagitis (EoE) and Non-GERD. MiVu device can also be used monitor treatment response in patients with GERD and EoE.
