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Senseonics Announces the FDA Approval to Continue the PROMISE Sensor Clinical Study in an Extended Cohort to 365 Days to Gather Feasibility Data
–The cohort of Eversense® CGM users will also test modified sensor chemistry.– GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE-American:
About this update from Senseonics Holdings, Inc.
[{"type":"text","content":"\n–The cohort of Eversense® CGM users will also test modified sensor chemistry.–\n\n GERMANTOWN, Md.--(BUSINESS WIRE)--\nSenseonics Holdings, Inc. (NYSE-American: SENS), a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system – the Eversense® CGM System – today announced the FDA approved a subgroup (with a modified chemistry to enhance longevity) of PROMISE study participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor.\n\n\n“We are very pleased that we received a prompt approval to extend the study to gather valuable data,” said Tim Goodnow, PhD, President and CEO of Senseonics. “The scientific, clinical and technical data we will obtain will be critical to further extend sensor longevity. We’re very grateful to the FDA for the green light, for the tireless clinical investigators, and particularly, to the devoted study participants for giving us this opportunity.”\n\n\nThe goal of the PROMISE Clinical Study is to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over a 180-day period for the pre-market application submission to the U.S. Food and Drug Administration. One hundred and eighty-one (181) study participants at 8 sites across the United States had the Eversense CGM System inserted subcutaneously as part of the study, which is completing the 180-day duration in March. Now, a sub-set of more than 35 participants who all had a sensor with the modified chemistry will be left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days.\n\n\n“Extending this study is really a critical step in developing a 365-day product. Information gathered from this cohort will allow us to characterize the improved sensor design and optimize our glucose algorithm for the extended, 365-day use period,” explained Mukul Jain, PhD, Chief Operating Officer at Senseonics. “This addition is an exciting extension phase of the PROMISE study and we look forward to evaluating the first multi-clinic investigation of a one-year implantable glucose sensor.”\n\n\nThe Eversense CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mo...