FDA Approves RefluxStop Implant for GERD
The FDA has granted premarket approval to RefluxStop, a non-drug implantable device developed by Implantica for the treatment of gastroesophageal reflux disease (GERD). The approval opens the U.S. market to this implant-based treatment option for patients with GERD.
FDA approval represents a transformational milestone for Implantica and follows the FDA's full review of the RefluxStop® PMA application, including the long-term clinical evidence supporting the 5-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.
Dr. Peter Forsell, CEO and founder of Implantica, says, "FDA approval of RefluxStop® is a defining landmark for Implantica and the culmination of many years of clinical development, scientific work, and rigorous regulatory review. Most importantly, it means that we can now bring RefluxStop® to the United States, where an estimated 78 million people suffer from acid reflux1.
We enter the U.S. market from a position of strength, with a substantially more mature clinical and commercial foundation than is typical for a newly approved medical device. RefluxStop® already has several years of commercial experience in Europe, close to 1,800 patients treated, more than 60 Centers of Excellence across nine European countries and published five-year clinical outcomes. Combined with our longstanding scientific engagement with many leading U.S. surgeons and experts, we believe this provides a strong foundation to launch and scale RefluxStop® in the U.S. market.
FDA approval changes our focus from preparation to execution. As the world's largest medtech market, the United States represents a substantial commercial growth opportunity for Implantica, and we are very excited to begin the U.S. launch of RefluxStop®. The initial rollout will be targeted, focusing on selected leading U.S. centers and reflux surgeons. Commercial adoption is expected to build gradually, reflecting the physician training and site activation required to establish RefluxStop® at each center. Our focus will be on disciplined execution, high-quality surgeon training, and building a solid commercial foundation for sustainable long-term growth."
