Eversense 365 Launches in the US: One Year. One CGM.

Oct 01 2024 16:00 BST

Manage diabetes and not CGM interruptions with the new Eversense 365 CGM system – the only One Year CGM that is designed to help minimize device frustrations

Ascensia launches the world’s first One Year CGM system in the US, with broad commercial coverage for people with diabetes

Pay as little as $199 out of pocket for One Year of continuous glucose monitoringⁱ, with only one payment a year

PARSIPPANY, N.J.--(BUSINESS WIRE)--Oct. 1, 2024-- Ascensia Diabetes Care, a global diabetes care company, announces that it is launching the Eversense^® 365 continuous glucose monitoring (CGM) system, the world’s only One Year CGM, to people with diabetes in the U.S.ⁱⁱ Developed by Senseonics Holdings, Inc. (NYSE American: SENS), Eversense 365 is the only CGM that provides one year of accurate monitoring with minimal disruptions, enabling confident decisions, long-term peace of mind, and enhanced quality of life with just one CGM. The device was cleared for use last month by the U.S. Food and Drug Administration (FDA) for people with type 1 and type 2 diabetes aged 18 years and older.

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Manage diabetes and not CGM interruptions with the new Eversense 365 CGM system – the only One Year CGM that is designed to help minimize device frustrations (Photo: Business Wire)

“Eversense offers a completely differentiated CGM experience, overcoming many of the frustrations experienced with traditional short-term CGMs, such as early failure, disruptive false alerts and skin irritation,” said Brian Hansen, President of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “With only one CGM replacement a year, fewer failed or wasted sensors, and alerts you can trust, Eversense 365 allows patients to live life uninterrupted by their diabetes technology. We can’t wait to get this game-changing product to people with diabetes and healthcare providers across the country.”

Eversense is the only One Year CGM that helps people to overcome common challenges experienced with traditional short-term CGMs, as highlighted in Ascensia’s new commercial launch campaign. The tiny sensor rests comfortably under the skin and provides exceptional accuracy over one yearⁱⁱⁱ, so that people can focus on managing their diabetes and not their CGM. Eversense has been found to reduce diabetes distress^iv and deliver significant improvements in glucose control^v, reducing the CGM device burden and allowing people to feel more empowered in their diabetes self-management.

“Managing diabetes can be hard work. When I was first diagnosed with type 1 diabetes, I spent a lot of time struggling to gain control and a big part of that was finding the right technology for my lifestyle,” says Troy Ita, a devoted family man, automotive sales coach and Eversense ambassador. “With traditional CGMs, I felt like I was managing both my diabetes and my technology. Frequent CGM interruptions are frustrating, expensive and time consuming, and the disruption was distracting me from important things like my family. With just one CGM needed for one year, Eversense 365 is going to significantly reduce the burden of managing diabetes, and I can’t wait to get started.”


Common CGM challenges	The Eversense 365 Solution
CGMs stop working before the indicated 10-14 day wear time.	Longest lasting CGM. The only CGM that lasts for a year, while traditional 10-14 day CGMs tend to fail early.^vi,vii,viii
Unexpected disruptions from CGMs getting knocked off.	No more wasted CGMs. The removable smart transmitter can be taken off when needed^ix. If the transmitter gets knocked off, simply put it back on without wasting a CGM.
Disruptive false alerts, including at night.	Trusted Alerts. Eversense 365 has exceptional accuracy for one year, with almost no compression lows and false alerts when sleeping.^x
Skin irritation or discomfort from harsh adhesives.	Maximum comfort. The gentle, silicone-based adhesives are changed daily and cause almost no skin reactions^xi.

Eversense is broadly covered by commercial insurance in the U.S. Eversense 365 is covered by the majority of commercial health plans and we are continuously working to broaden access as widely as possible to the product’s unique benefits. Additionally, Eversense 365 is launching alongside a new Eversense 365 Payment Assistance and Simple Savings (PASS) program^xii. Under the program, eligible individuals will pay as little as $199 out of pocket for One Year of continuous glucose monitoringⁱ, with only one payment per year.

Potential Eversense users can go to www.eversensecgm.com to learn more. Physicians, nurse practitioners and physician assistants who are interested in offering the Eversense 365 CGM System can sign up at www.ascensiadiabetes.com/eversense/become-a-provider/. Alternatively, contact 844-SENSE4U (736-7348) to learn more about the first and only long-term implantable CGM system.

Notes for Editors

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 13 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 www.eversensediabetes.com/safety-info/.

A media kit for Eversense 365, including images, logos and further information, can be accessed at www.ascensia.com/media/eversense365-media-kit/.

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: www.ascensia.com

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^® 365 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 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 FY2023 were JPY 353.9 billion with global distribution of products and services in more than 125 countries.

www.phchd.com

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ⁱ This excludes the costs of insertion and removal

ⁱⁱ Eversense 365 is now being marketed in the US, with product expected to be commercially available in the coming weeks

ⁱⁱⁱ Senseonics. (2024) Eversense 365 CGM System User Guide.

^iv An 8.5% reduction in total diabetes distress over two years of Eversense CGM system use (n=273). Source: Tweden KS, et. al. Data presented during ATTD 2024. Patient reported outcomes of the Eversense CGM system in the U.S. Post approval setting.

^v Tweden KS, et al. (2023) Implantable CGM Use Improves Glycemic Control in CGM Naive Patients. Interventions Obes Diabetes. 6(1). DOI: 000635.2023

^vi Senseonics. (2024) Eversense 365 CGM System User Guide.

^vii Abbott. (2024) Freestyle Libre 3 User Guide ART49385-001 Rev. A 04/24

^viii Dexcom (2024) G7 User Guide AW00078-10 Rev 003 MT-00078-10

^ix There is no glucose data generated when the transmitter is removed

^x Christiansen MP, Klaff LJ, Brazg R, et al. (2018) A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther. 20(3):197-206. doi:10.1089/dia.2017.0142

^xi 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.

^xii Offer does not apply to the insertion and removal procedures. The Eversense PASS Program has limitations on eligibility. See website for more details. Ascensia Diabetes Care reserves the right to change or terminate this program at any time without notice. There may be instances in which out-of-pocket costs exceed what is detailed in the offer. The maximum program benefit is $2,500 per transaction.

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Ascensia Communications Contact:
Lorraine Chandler
Head of Corporate Communications
Lorraine.chandler@ascensia.com

Senseonics Investor Contact
Jeremy Feffer
LifeSci Advisors
investors@senseonics.com

Source: Ascensia Diabetes Care