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

Rhea-AI Summary

Ascensia Diabetes Care has launched the Eversense 365 continuous glucose monitoring (CGM) system in the US. Developed by Senseonics Holdings (NYSE American: SENS), it's the world's first and only One Year CGM system, recently cleared by the FDA for people with type 1 and type 2 diabetes aged 18 and older.

Key features of Eversense 365 include:

• One-year accurate monitoring with minimal disruptions
• A tiny sensor that rests under the skin
• Exceptional accuracy over one year
• Reduced diabetes distress and improved glucose control
• Broad commercial insurance coverage

Eligible individuals can pay as little as $199 out of pocket for one year of continuous glucose monitoring through the new Eversense 365 Payment Assistance and Simple Savings (PASS) program.

Positive

• Launch of Eversense 365, the world's first One Year CGM system, in the US market
• FDA clearance for use in type 1 and type 2 diabetes patients aged 18 and older
• Broad commercial insurance coverage for the product
• New payment assistance program offering eligible individuals CGM for as low as $199 per year
• Potential for reduced diabetes distress and improved glucose control for users

Negative

• None.

Insights

Medical Device Analyst

The launch of Eversense 365, the world's first one-year continuous glucose monitoring (CGM) system, represents a significant advancement in diabetes management technology. This FDA-cleared device offers several key advantages over traditional short-term CGMs:

• Exceptional longevity: Lasts for one full year, reducing the frequency of sensor replacements
• Improved accuracy: Maintains accuracy over the entire year-long period
• Reduced false alerts: Fewer disruptive notifications, especially during sleep
• Skin-friendly: Uses gentle silicone-based adhesives, minimizing skin irritation
• Flexibility: Removable transmitter allows for temporary removal without wasting the sensor

These features address common pain points in CGM usage, potentially improving patient adherence and quality of life. The broad commercial insurance coverage and the new payment assistance program ($199 out-of-pocket for a year) make it accessible to a wider patient population. This launch could significantly impact the competitive landscape of the CGM market, potentially driving innovation among competitors and reshaping patient expectations for diabetes management technology.

Financial Analyst

The launch of Eversense 365 is a pivotal moment for Senseonics Holdings (NYSE American: SENS) and its partner Ascensia Diabetes Care. This innovative product addresses key market needs and has several financial implications:

• Market Differentiation: The one-year lifespan is a unique selling point that could capture market share from established players.
• Recurring Revenue Model: Annual replacements create a steady, predictable revenue stream.
• Cost Efficiency: Fewer sensor replacements may lead to reduced manufacturing and distribution costs.
• Insurance Coverage: Broad commercial coverage suggests potential for rapid market penetration.
• Pricing Strategy: The $199 out-of-pocket cost for a year's use is competitive and may drive adoption.

While the initial impact on Senseonics' stock may be positive, investors should monitor adoption rates, production scalability and competitive responses from other CGM manufacturers. The success of Eversense 365 could significantly improve Senseonics' financial position and market valuation in the medium to long term.

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)-- 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.

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 neededix. 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 reactionsxi.

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

©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.

_____________________________________

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.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240930163080/en/

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

FAQ

What is the Eversense 365 CGM system and how long does it last?

Eversense 365 is a continuous glucose monitoring system that lasts for one full year, making it the world's first and only One Year CGM system.

Has the FDA approved Eversense 365 (SENS) for use in the US?

Yes, the FDA has cleared Eversense 365 for use in people with type 1 and type 2 diabetes aged 18 years and older in the US.

How much does Eversense 365 (SENS) cost for eligible individuals?

Through the Eversense 365 Payment Assistance and Simple Savings (PASS) program, eligible individuals can pay as little as $199 out of pocket for one year of continuous glucose monitoring.

What are the key advantages of Eversense 365 (SENS) over traditional CGMs?

Eversense 365 offers one-year accurate monitoring, fewer disruptions, reduced early failures, fewer false alerts, and less skin irritation compared to traditional short-term CGMs.