SENS Senseonics Holdings Inc

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, today 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 (TSE: 6523), 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 early1, 2, 3
• 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 year1, with almost no false alerts from compression lows when sleeping5
• Maximum comfort: The gentle silicone-based adhesives are changed daily and causes almost no skin reactions6
• 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 removed1Senseonics. (2024) Eversense 365 User Guide.2 Abbott. (2024) Freestyle Libre 3 User Guide ART49385-001 Rev. A 04/243 Dexcom (2024) G7 User Guide AW00078-10 Rev 003 MT-00078-104 Data on file5 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.2017.01426 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

About Senseonics

Senseonics Holdings, Inc. ("Senseonics") is a medical technology company focused on the development and manufacturing 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.

About Eversense

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 Ascensia Diabetes Care

Ascensia Diabetes Care is a global company focused entirely on helping people with diabetes. Our mission is to empower those living with diabetes through innovative solutions that simplify and improve their lives. We are home to the world-renowned CONTOUR® portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense® Continuous Glucose Monitoring Systems from Senseonics. These products combine advanced technology with user-friendly functionality to help people with diabetes manage their condition and make a positive difference to their lives. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.Ascensia is a member of PHC Group and was established in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings Corporation. Ascensia products are sold in more than 100 countries. Ascensia has around 1,400 employees and operations in 29 countries.For further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com.

Forward Looking Statements

Any statements in this press release about the expectations regarding anticipated EU regulatory progress, potential clearance and EU launch of Eversense 365, expectations for the commercial product launch, trends of interest in, and market acceptance and adoption of, Eversense 365 by patients and prescribers, potential impact on patients lives and outcomes, future differentiating characteristics from other products, progress of potential AID partnerships, 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 development and registration of new technology, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the new product launch and ongoing commercialization of Eversense 365, uncertainties inherent in the reliance on the commercialization efforts and investment of Ascensia and its commercial initiatives, uncertainties in prescriber and patient decisions and responses to new technology or initiatives, uncertainties in the development of and competition in the overall CGM market, 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, 2023 and subsequent quarterly reports on Form 10-Q 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 ContactJeremy FefferLifeSci Advisorsinvestors@senseonics.com