Eversense® CGM System Receives iCGM Designation by the US FDA

The first fully implantable continuous glucose monitors can now be integrated with insulin pumps as part of an automated insulin delivery system

GERMANTOWN, Md. & PARSIPPANY, N.J.–(BUSINESS WIRE)–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, announced that Eversense^® has been granted an integrated CGM (iCGM) designation by the US Food and Drug Administration (FDA).

As the first fully implantable device in the category, Eversense has been authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future for devices of the same type.

iCGM status indicates that Senseonics’ Eversense iCGM product can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system. The companies plan to advance partnership discussions with various pump manufacturers, with plans to offer people who choose to integrate their diabetes devices a new interoperable CGM option that is exceptionally well suited for AID systems. This is because Eversense addresses common limitations of AID systems outlined in the 2022 Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.¹

“Managing diabetes is all about personal choice and finding the options that best support an individual to live a healthier, less interrupted life,” said Brian Hansen, President of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “For many, one of these choices is to take some of the calculation out of diabetes management by integrating their CGM with an insulin pump as part of an AID system. We are pleased that Eversense has been granted iCGM designation by the FDA, so that people who desire this integration in the future will be able to choose Eversense and access its unique benefits.”

“The iCGM designation has been a core component of our strategic initiatives to advance our pipeline, and we are excited to move forward with the next steps to accelerate integration of the world’s longest lasting CGM with leading insulin devices,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “The rigorous data requirements for this FDA designation highlight our team’s advanced engineering expertise in developing a CGM that meets high standards. Our confidence in our differentiated technology is high, as there is a tremendous opportunity with iCGM to deliver value and provide substantial benefits to diabetes patients. As we look ahead, we are focused on progressing our partnership discussions and software developments, and look forward to providing more updates.”

Designed by Senseonics and brought to people with diabetes by Ascensia, the Eversense CGM System offers a fully implantable option that is exceptionally well suited for AID therapy:

• The longest lasting CGM available with 6 months of wear time and only one insertion and one “Day 1”
• Most accurate CGM in critical low glucose ranges^2,3,4,5 with essentially no compression lows⁶
• Most dependable CGM alert detection to support accurate corrections in real time⁷
• The only CGM with a removable transmitter which can be taken on and off without wasting a sensor or adding a warm up period^†

Potential Eversense users can go to www.ascensiadiabetes.com/eversense to learn more. Physicians, nurse practitioners and physician assistants who are interested in offering 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 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

² Garg S. et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study. Diabetes Technology & Therapeutics 2021; 24(2): 1-9.DOI: 10.1089/dia.2021.0182

³ Barnard KD, Kropff J, Choudhary P, et al. Acceptability of Implantable Continuous Glucose Monitoring Sensor. J Diabetes Sci Technol. 2018;12(3):634-638. doi:10.1177/1932296817735123

⁴ Boscari F, Vettoretti M, Cavallin F, et al. Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance. J Endocrinol Invest. 2022;45(1):115-124. doi:10.1007/s40618-021-01624-2

⁵ Hanson K, Kipnes M, Tran H. Comparison of Point Accuracy Between Two Widely Used Continuous Glucose Monitoring Systems. J Diabetes Sci Technol. Published online January 8, 2024. doi:10.1177/19322968231225676

⁶ 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

⁷ Eversense E3 User Manual LBL-4002-01-001 Rev B 02/2022

Notes for Editors

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 system Eversense® E3 includes 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® E3 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 180 days in persons with diabetes age 18 and older. The system is 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 a day after day 21, 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 E3 CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see https://www.ascensiadiabetes.com/eversense/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

About PHC Holdings Corporation

PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience Corporation, Mediford Corporation, and Wemex. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2022 were JPY 356.4 billion with global distribution of products and services in more than 125 countries.

www.phchd.com

©2024 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements regarding announced changes taking effect as planned, statements regarding growing the awareness, adoption, growth and potential of Eversense, statements regarding potential plans and prospects for partnerships with pump manufacturers, for integrated AID systems incorporating Eversense, for the attributes and value to patients of any such systems, and for regulatory submissions and approaches for the Eversense product, 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 in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development of new technology, uncertainties related to the reliance on discussions and arrangements with pump manufacturers and other third parties, uncertainties inherent in the ongoing commercialization of the Eversense product, uncertainties inherent in Ascensia’s performance and other commercial initiatives, uncertainties relating to the current economic environment 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 Senseonics’ other filings 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.

Contacts

ADC Communications Contact

Lorraine Chandler

Lorraine.chandler@ascensia.com

Senseonics Investor Contact
Philip Taylor

Gilmartin Group

415-937-5406

Investors@senseonics.com