Implantica publishes Year-end Report, January – December 2021
GREAT PROGRESS IN U.S. APPROVALSignificant events in the fourth quarter of 2021 · The U.S. approval has taken a giant leap forward since the FDA has agreed to receive a PMA marketing application for RefluxStop™ based solely on existing European clinical data. If approved, this would allow for U.S. market entry without a premarket U.S. clinical trial. As agreed with FDA, Implantica will provide the FDA with additional current longer-term safety and efficacy data from its ongoing European clinical investigation. · The fourth wave of COVID-19 has affected RefluxStop™ surgeries with