Implantica submits the last and final module 3 of the FDA PMA Application for RefluxStop® for US market approval
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Implantica submits the last and final module 3 of the FDA PMA Application for RefluxStop® for US market approval
Implantica AG (publ.), a MedTech company at the forefront of introducing advanced technology into the body, including the unique device RefluxStop® for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces the submission of the third and final module of the RefluxStop® pre-market approval (PMA) application with the US Food and Drug Administration (FDA), along with responses to the second module.
Implantica submitted the last and final Module 3 of the RefluxStop® PMA application together with the response to Module 2 review findings to FDA yesterday. Module 2, the clinical module, primarily addressed what we believed were minor findings. Module 3 is focused on tests of the product such as bench testing and biocompatibility testing for the RefluxStop® device.
In line with the positive feedback in the FDA PMA application process so far, the latest RefluxStop® data submitted as part of the Module 2 response, as well as in the final Module 3, is quite robust and conclusive in Implantica’s opinion. We hope the newly submitted data and responses will not only continue to meet the stringent requirements for the PMA approval process but also exceed them. The continued process relies to a large extent now on FDA, which will guide Implantica in the coming steps. FDA’s feedback on Module 3 is expected sometime in the autumn.
Inventor of RefluxStop®, Founder and CEO of Implantica, Dr. Peter Forsell, says, “I want to extend my gratitude to U.S. FDA for this thorough evaluation process of every facet of a new technology, such as RefluxStop®. Now more than ever, I believe we are on the cusp of a new generation of much needed surgical solutions for GERD with the potential to transform the standard of care for GERD patients in the U.S…”
Dr Forsell continues, “This is a significant milestone for Implantica, one we all waited for. Undoubtedly, GERD is a grave and growing issue in the U.S. today, impacting approximately 22-27% of adults in the U.S. population. With over 1300 patients treated across nearly 50 centers in Europe and excellent long-term 5-year data results from the pivotal study, I believe RefluxStop® is poised to help these hugely underserved patients in the U.S. and worldwide in the years to come!”