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Senseonics Announces FDA Approval of the Eversense® E3 Continuous Glucose Monitoring System for Use for Up to 6 months; Provides 2022 Business Outlook
The world’s first and only long-term implantable CGM system now offers patients exceptional accuracy for 6 months GERMANTOWN, Md.--(BUSINESS WIRE)--
About this update from Senseonics Holdings, Inc.
[{"type":"text","content":"\nThe world’s first and only long-term implantable CGM system now offers patients exceptional accuracy for 6 months\n\n GERMANTOWN, Md.--(BUSINESS WIRE)--\nSenseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the approval of the next-generation Eversense® E3 CGM System by the Food and Drug Administration (FDA). The Eversense E3, including proprietary sacrificial boronic acid (SBA) technology to extend longevity to 6 months, is planned to be available to patients in the U.S. through Ascensia Diabetes Care, Senseonics’ global commercial partner, beginning in the second quarter of 2022.\n\n“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” said Satish Garg, M.D., Professor of Medicine and Director of the Adult Diabetes Program at the Barbara Davis Center of the University of Colorado, and the Principal Investigator of the PROMISE Study1, which formed the basis for the FDA approval. “The next generation Eversense E3 System delivers on both. Patients will appreciate the excellent accuracy of the system and the ability of the sensor to last 6 months. This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.”\n\nThe Eversense E3 CGM System offers patients:\n\n\nFully implantable third generation sensor, with proprietary SBA technology to enhance sensor longevity, demonstrating a mean absolute relative difference (MARD) of 8.5% in the PROMISE Study.\n\n\nIndustry leading 6 month sensor wear duration, making Eversense the longest lasting CGM system available, with essentially two sensor insertion and removal procedures per year.\n\n\nRemovable smart transmitter, held in place with a mild silicone-based adhesive, providing discreet on-body vibratory alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed.\n\n\n“Further extending the duration of the longest lasting CGM system to 6 months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community,” said Tim Goodnow, PhD, Presid...