Implantica Submits FDA PMA Application Clinical Module 2 For Refluxstoptm For U.S. Market Approval

VADUZ,
Liechtenstein, Nov. 14, 2024 /PRNewswire/ -- Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStopTM for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces the submission of the second clinical module of the Premarket Approval (PMA) application to the US FDA for RefluxStop TM along with responses to the FDA's findings from the first module.

The second module submitted earlier this week for the RefluxStopTM PMA is the most crucial module of the three-module process for FDA approval. The outcome of our clinical study submitted to FDA shows fantastic positive results, which has echoed around the surgical community, fueling a vibrating interest in RefluxStop among surgeons and GIs all around the world and especially in the U.S. Together with Module 2, responses to the FDA's findings from Module 1 were also submitted, which the company believes are minor findings. In addition, the finalization of Module 3 is ongoing. The US FDA has agreed to a modular submission process for the RefluxStopTM PMA application, which allows for ongoing review and feedback from the FDA as each module is submitted.

Dr. Peter Forsell, CEO of Implantica, says, "The incredible enthusiasm for RefluxStopTM among top surgeons at the recent annual American Foregut Society and European Foregut Society meetings is a testimony to the immense demand for innovation in the surgical treatment of GERD. This support is growing fast, fueled by RefluxStop's excellent clinical outcomes, both in our pivotal 5-year study but also supported by multiple centers around Europe presenting their equally excellent results. This even further demonstrates the potential of RefluxStopTM to become the standard of care for GERD patients in the U.S. pending final FDA approval."

Dr. Forsell continues, "We're thrilled to mark this crucial milestone in bringing an urgently needed innovative surgical treatment for GERD to patients in the U.S., the world's largest anti-reflux procedures market. We're sincerely grateful to the FDA for allowing Implantica to participate in the expedited module process based on the excellent 5-year clinical results from the RefluxStopTM CE mark study. As of today, nearly 1,000 patients have been treated with RefluxStopTM across more than 35 centers in Europe, and we can't wait to get this treatment to the US patients in large need."

In the U.S. today, approximately 27% of the adult population deals with the painful symptoms of GERD1, and 40% of GERD patients don't respond to the most common medication to treat the disease, PPIs.2 RefluxStopTM treats the root cause of GERD by surgically restoring the natural physiology of the body, thus eliminating the need for PPIs to manage GERD symptoms, as seen in the 5-Year RefluxStopTM CE mark study participants. What has become clear from our 5-year study data is that RefluxStopTM both treats acid reflux much better and that with substantially reduced complication rates compared to standard of care Nissen fundoplication.

Reference:

MENAFN14112024003732001241ID1108884885