Senseonics: Eversense 365 Receives FDA Clearance

Senseonics 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 and Ascensia Diabetes Care, a global diabetes care company, today announced that the US Food and Drug Administration (FDA) has cleared the next-generation Eversense® 365 CGM system for people with Type 1 and Type 2 diabetes aged 18 years and older. Eversense 365 is the world’s first One Year CGM system, representing a significant breakthrough in diabetes technology and management.

“The approval of Eversense 365 represents a significant leap in CGM innovation. Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower A1c. The delivery of the world’s first 365 day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes.”

“Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” said Brian Hansen, President of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics’ ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible. In parallel, our partnership discussions with various pump manufacturers continue to progress, as we look to leverage Eversense 365’s unique potential to simplify life with integrated automated insulin delivery (AID) systems.”

Eversense 365 is supporting people with diabetes to live life uninterrupted, as a fully-implantable, long-term CGM option that is highly-differentiated from short-term CGMs:

• Longest lasting CGM: The only CGM with a 365-day sensor means no frequent sensor changes, and only one insertion and one “Day 1” every year, compared to every 10-14 days with short-term CGM systems
• Most dependable CGM: Sensor survivability across 12 months reduces the burden of data interruptions from frequent short-term CGM sensor failures or changes1, 2, 3
• No more wasted sensors: A tiny sensor that rests comfortably under the skin means that it cannot be knocked off, minimizing the inconvenience and cost of regular replacements
• Alerts that can be trusted: Exceptional accuracy consistently for one year4 and almost no false alerts from compression lows during the night5
• Maximum comfort: A gentle silicone-based adhesive that can be changed daily and causes almost no skin reactions6
• More freedom: The only CGM with a removable transmitter which can be easily taken on and off† without wasting a sensor or adding a warm up period
• Improved discretion: On-body vibration alerts keep patients notified even when their mobile phone is out of sight

Ascensia expects to initiate the US launch of Eversense 365 US in the fourth quarter of 2024, with work ongoing to transition coverage availability in order to facilitate immediate access to as many users as possible.

Eversense 365 has been cleared 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 exceptionally well suited to address common limitations7 of AID systems and the companies are advancing partnership discussions with various pump manufacturers.

To learn more about Eversense 365 and for additional information about when the system will be available, go to www.eversensecgm.com. Physicians, nurse practitioners and physician assistants who are interested in prescribing the Eversense CGM System can sign up at https://www.ascensiadiabetes.com/eversense/become-a-provider/. Alternatively, contact 1-844-SENSE4U (1-844-736-7348) to learn more about the first and only long-term implantable CGM system.

† There is no glucose data generated when the transmitter is removed
1 Senseonics. (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

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