Tämä ketju on ollut hyvin hiljainen. Implantica on kuitenkin ollut hyvin kiinnostava taas viime kesästä alkaen, kun potilaiden seurannan tuloksia julkaistiin.
Nyt FDA on antanut positiivista palautetta, koskien moduuli 2:ta hakuprosessissa. Tämä on kattavin ja tärkein moduuleista. Moduuli yksihän on hyväksytty.
Implantica announces positive feedback received from U.S. FDA of the RefluxStop™ PMA Module 2 submission
Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop™ for the treatment of acid reflux, a treatment field with 1 billion sufferers, announces that U.S. FDA has completed its review of the PMA Module 2 submission and provided its feedback, in which the company sees no barrier for responding.
FDA has completed its review of the company’s second modular submission of its PMA, which contained the Clinical Data, Usability Testing, and Labeling information supporting RefluxStop™. FDA has provided Implantica with its written feedback on the content submitted, all of which the company considers to be minor. A response strategy has been identified for the questions raised, and the company sees no impediment to the overall PMA approval process based on FDA’s Module 2 feedback. Responses to the Module 2 feedback will be submitted in conjunction with the final Module 3 submission in the near term.
Dr. Peter Forsell, Implantica’s founder, CEO, and the inventor of RefluxStop, says, "We are thankful for FDA for their review of Module 2 and are pleased to receive their positive feedback on our submission thus far. Module 2 includes the results of the RefluxStop™ clinical study and is by far the most important module for this PMA from our perspective. The 5-year outcomes in conjunction with data reported in the literature are extremely positive and indicate that RefluxStop™ may revolutionize this treatment field. Implantica will, in the near term, submit the last component of our PMA application (Module 3) and work with FDA to bring RefluxStop™ to the U.S. market as soon as possible.”