Implantica Submits Final Module 3 for RefluxStop® FDA PMA Approval in the U.S.
Implantica Submits Final Module 3 for RefluxStop® FDA PMA Approval
On June 24, 2025, Implantica AG, a MedTech company based in Liechtenstein, made a crucial step towards revolutionizing treatment for gastroesophageal reflux disease (GERD) by submitting the final Module 3 of its premarket approval (PMA) application for the RefluxStop® device to the U.S. Food and Drug Administration (FDA). This submission is part of the broader effort to secure FDA endorsement for a product that could change the lives of over one billion individuals suffering from acid reflux worldwide.
The RefluxStop® device is designed specifically to provide an innovative solution for GERD, a condition that afflicts approximately 22-27% of adults in the United States. Unlike conventional surgical treatments that encircle the esophagus, potentially leading to complications like swallowing difficulties, RefluxStop® addresses the underlying causes of acid reflux without compromising the normal anatomical passageway. By restoring and maintaining the lower esophageal sphincter in its natural position, RefluxStop® has shown promise in improving patient outcomes.
In this most recent submission, Implantica has included responses to the FDA's Module 2 review findings, which primarily involved what the company deemed minor issues previously identified. The focus of Module 3 is centered on product testing, including essential assessments such as bench testing and biocompatibility evaluations. Implantica remains confident that the robust data presented will satisfy the FDA's comprehensive requirements and potentially exceed them.
Dr. Peter Forsell, the inventor of RefluxStop® and the CEO of Implantica, expressed his appreciation for the rigorous review process by the FDA. He stated, "We are on the brink of introducing a new generation of surgical solutions for GERD, which could fundamentally change the standard of care for patients across the U.S. and beyond." With over 1,300 patients treated in nearly 50 centers throughout Europe, the clinical data corroborates the efficacy and safety of this innovative device. The long-term outcomes from pivotal studies are promising, suggesting that RefluxStop® can significantly enhance the quality of life for those battling chronic acid reflux.
As the approval process now rests significantly with the FDA, feedback regarding Module 3 is anticipated in the autumn of 2025. Should the FDA grant the necessary approvals, Implantica is poised to introduce RefluxStop® into the United States market, offering hope to the countless individuals who have struggled with the complications and discomfort associated with GERD.
Implantica is also dedicated to expanding its technological footprint beyond surgical solutions. The company is committed to integrating eHealth technology within therapeutic applications, focusing on remote monitoring and wireless communication with healthcare providers. This approach promises to enhance patient management and ensure better outcomes.
Overall, the submission of the final module marks a pivotal milestone for Implantica and hints at a future where advanced medical solutions might reshape how conditions like GERD are managed. With ongoing research, the company aims to support a paradigm shift in anti-reflux treatment, ensuring that the concerns of underserved populations gain the attention they require.
For more details about Implantica and RefluxStop®, visit their official website or follow them on their social media platforms. The journey toward FDA approval is a notable chapter in their mission to redefine medical solutions in gastroenterology, reflecting their commitment to innovation, research, and patient care.