Senseonics Submits Eversense 365 for CE Mark Approval

Senseonics Holdings, Inc. a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, announced it has filed for CE Mark registration for the Eversense^® 365 CGM system.

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US) Food and Drug Administration in September of 2024 and launched across the country in October of the same year.

The Eversense 365 CE Mark submission was prepared in compliance with the EU Medical Device Regulation (MDR) and, upon approval, would enable the commercialization of Eversense 365 in European Union (EU) member countries by Senseonics’ commercial partner, Ascensia Diabetes Care. Following CE Mark approval in Europe, the Company plans to distribute the Eversense 365 System in Germany, Italy, Spain (including Andorra), Poland, Switzerland and Sweden.

“Completing the CE Mark submission for Eversense 365 brings us a step closer to improving lives and health outcomes for patients in Europe. Given the success we have had to date with the US launch of Eversense 365 by our partner, Ascensia, we look forward to the opportunity to offer a ‘once a year’ solution for glucose control to the millions of people living with diabetes in the European Union,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics.

Brian Hansen, President of CGM for Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation, added, “the feedback we have received since our US launch from endocrinologists, general practitioners and patients with diabetes has been extremely encouraging. Eversense 365 is having a tangible impact to the lives of many and we hope to have the opportunity to create a similar impact for patients living with diabetes in Europe.”

The Eversense 365 CGM System offers a differentiated CGM experience, having been designed to deliver key improvements over traditional, short-term CGMs:

• Longest lasting CGM: The only CGM that lasts for a year, while traditional 10-14 days CGMs tend to fail early
• No more wasted CGMs: The tiny sensor is designed to rest comfortably under the skin. Plus, the removable smart transmitter can be taken off^† and put back on without wasting a CGM
• Trusted alerts: Eversense 365 has exceptional accuracy for one year, with almost no false alerts from compression lows when sleeping
• Maximum comfort: The gentle silicone-based adhesives are changed daily and causes almost no skin reactions
• Consistent and reliable accuracy: Just one calibration per week provides confidence in treatment decisions at every stage of sensor life

Eversense 365 has been cleared in the US as an integrated CGM (iCGM) system, indicating that it can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system. Eversense 365 is well-suited to address common limitations⁷ of AID systems and the companies are advancing partnership discussions with various pump manufacturers.

^† There is no glucose data generated when the transmitter is removed
¹Senseonics. (2024) Eversense 365 User Guide.
² Abbott. (2024) Freestyle Libre 3 User Guide ART49385-001 Rev. A 04/24
³ Dexcom (2024) G7 User Guide AW00078-10 Rev 003 MT-00078-10
⁴ Data on file
⁵ Christiansen MP, Klaff LJ, Brazg R, et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther. 2018;20(3):197-206. doi:10.1089/dia.2017.0142
⁶ Deiss, D. et al. (2020). Real-world safety of an implantable continuous glucose sensor over multiple cycles of use: A post-market registry study. Diabetes Technology & Therapeutics, 22(1), 48–52.
⁷ Sherr JL, Heinemann L, Fleming GA, et al. Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association. Diabetologia. 2023;66(1):3-22. doi:10.1007/s00125-022-05744-z