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Senseonics Submits PMA Application for 180-Day Eversense System to the FDA
PROMISE Study Demonstrated Strong Accuracy Performance, Consistent with Current Eversense CGM System GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings,
About this update from Senseonics Holdings, Inc.
[{"type":"text","content":"\nPROMISE Study Demonstrated Strong Accuracy Performance, Consistent with Current Eversense CGM System \n\n GERMANTOWN, Md.--(BUSINESS WIRE)--\nSenseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the Premarket Approval (PMA) supplement application to extend the wearable life of the Eversense® CGM System to 180 days was submitted to the United States Food and Drug Administration (FDA) on September 30. Summary accuracy results from the PROMISE Clinical Study for the 180-day product were also announced.\n\nThe PMA application is supported by clinical data generated from the PROMISE Clinical Study. The 181 study participants had the Eversense sensor inserted subcutaneously at eight sites across the United States where the safety and efficacy of the system was evaluated over a 180-day period. Study results demonstrate performance matching that of the current Eversense 90-day product available in the United States, with a mean absolute relative difference (MARD) of 8.5%-9.6%. This result was achieved with reduced calibration, down to one per day, while also doubling the sensor life to 180 days. Research results from the PROMISE Clinical Study will be presented at future diabetes meetings, as well as through scientific publications.\n\n“The Barbara Davis Research Center, a leading Type 1 Diabetes Clinic, was pleased to participate in this important clinical trial that was designed to evaluate the new 180-day long-term implanted Eversense CGM System. In my practice, CGM use has proven to be one of the most effective tools for diabetes management, but unless patients are consistently compliant with system usage, these benefits cannot be realized. The majority of our patients, greater than 70%, use one of the FDA approved CGM Systems for their day-to-day diabetes management. In the PROMISE Clinical Study, we observed that the implantable sensor provides ease of use and convenience to patients that helps maximize the benefits of CGM,” said Satish Garg, MD, National Principal Investigator of the PROMISE Clinical Study and Professor of Medicine and Pediatrics at the Barbara Davis Center, University of Colorado Health. “We seek to provide patients with cuttin...