GERMANTOWN, Md., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NASDAQ: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 CE Mark approval 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 is now approved for commercialization in the European Union (EU). The Company expects to launch Eversense 365 in Germany, Italy, Spain and Sweden in the coming months.

"European approval for Eversense 365 represents the latest achievement in our long-term growth strategy for Senseonics and expands our total addressable market by over 30 million patients living with diabetes in the EU. As we take full ownership of all commercial activities for Eversense 365, we expect our expansion in Europe to contribute to top-line revenue growth, while offering a single year-long CGM solution to glucose monitoring," said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. "2026 will be an exciting year as we drive commercial progress in the U.S. and Europe, expect the impact of the integration with Sequel's twiist™ Automated Insulin Delivery (AID) System in the U.S., and simultaneously await planned completion of the Gemini trial in the second half of the year."

The Eversense 365 CGM System has been designed to deliver key improvements from currently available 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 changes^{1, 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

Eversense 365 has been cleared as an integrated CGM (iCGM) system in the United States, 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 Company is 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

⁴Data 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

⁶Deiss, 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

About Eversense

Eversense 365 is developed by Senseonics and, as the only implantable CGM available, offers patients a truly differentiated CGM experience, providing One Year of exceptionally accurate monitoring with minimal interruptions. It benefits endocrinologists and care teams by offering their patients confidence in decision-making, long-term peace of mind and enhanced quality of life with just one CGM. The unique approach also allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.

About Senseonics

Senseonics Holdings, Inc. ("Senseonics") is a medical technology company focused on the development, manufacturing and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems Eversense® 365 and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including expected sales growth, the expansion of the addressable market, the timing of the European launch of Eversense 365, business expansion in Europe, the integration with the Sequel twiist AID system, expected progress of the Gemini clinical trial, advancing partnership discussions for AID solutions, and the potential benefits and accuracy related to using the the Eversense 365, and other statements containing the words "believe," "expect," "intend," "may," "projects," "will," "planned," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the commercialization, launch and sale of new products, uncertainties inherent executing corporate acquisions and the transition of commercial activities from Ascensia to Senseonics, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration and roll-out of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms and coordination with health systems and other new collaboration partners and third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product and Senseonics' and its partners' activities, uncertainties relating to the current economic and regulatory/political environment, including the effects of tariffs, and such other factors as are set forth in the risk factors detailed in Senseonics' Annual Report on Form 10-K for the year ended December 31, 2024, the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and future reports filed with the SEC under the heading "Risk Factors." In addition, the forward-looking statements included in this press release represent Senseonics' views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics' views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics' views as of any date subsequent to the date hereof.

Senseonics Investor Contact

Jeremy Feffer

LifeSci Advisors

investors@senseonics.com

Senseonics Receives European Approval for Eversense 365, World's Longest-lasting Continuous Glucose Monitor