Medical technology company Implantica AG (Nasdaq First North Premier Growth Market: IMP A SDB) announced on Thursday that the US Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for RefluxStop, the company's implant-based treatment for gastroesophageal reflux disease (GERD).
This approval allows Implantica to begin commercial launch activities in the United States, the world's largest medical device market.
FDA approval follows the regulator's full review of the RefluxStop PMA application, including long-term clinical evidence supporting the five-year safety and effectiveness of the therapy.
RefluxStop is designed to address the underlying cause of acid reflux by restoring and maintaining the natural anatomy of the gastroesophageal junction, without encircling or applying pressure on the food passageway.
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