Eversense 365 Receives FDA Clearance: The World’s First One Year CGM

Rhea-AI Summary

Senseonics Holdings, Inc. (NYSE American: SENS) and Ascensia Diabetes Care announced FDA clearance for the Eversense 365 CGM system, the world's first one-year continuous glucose monitoring system for people with Type 1 and Type 2 diabetes aged 18 and older. This breakthrough device offers:

• 365-day sensor longevity, reducing frequent sensor changes
• High accuracy and dependability over 12 months
• Removable transmitter for flexibility
• On-body vibration alerts for discretion

Eversense 365 is cleared as an integrated CGM (iCGM) system, compatible with insulin pumps for automated insulin delivery. The U.S. launch is expected in Q4 2024, with Ascensia working to ensure immediate access for users.

Positive

• FDA clearance for Eversense 365, the world's first one-year CGM system
• Significant reduction in sensor changes (annually vs. every 10-14 days)
• Cleared as an iCGM system, compatible with automated insulin delivery systems
• Improved accuracy and dependability over 12 months
• Potential for expanded market share in the CGM space
• Expected launch in Q4 2024, indicating near-term commercialization

Negative

• Delayed market entry, with launch not expected until Q4 2024
• Potential challenges in transitioning coverage for immediate user access
• Competition from established short-term CGM providers in the market

Insights

Medical Research Analyst

The FDA clearance of Eversense 365 marks a significant leap in CGM technology. As the world's first one-year continuous glucose monitoring system, it addresses major pain points in diabetes management. The 365-day sensor life is a game-changer, drastically reducing the frequency of sensor changes from every 10-14 days to just once a year. This extended longevity could potentially improve patient adherence and quality of life.

The system's iCGM designation is crucial, allowing integration with insulin pumps for automated insulin delivery (AID) systems. This interoperability could lead to more comprehensive diabetes management solutions. However, the Q4 2024 launch timeline means a considerable wait before market impact. The focus on transitioning coverage availability suggests potential initial access barriers that could affect adoption rates.

Financial Analyst

Senseonics' (NYSE American: SENS) FDA clearance for Eversense 365 could be a significant catalyst for the company's financial performance. The one-year CGM system represents a unique value proposition in the competitive diabetes care market, potentially driving market share gains and revenue growth.

However, investors should note the delayed commercialization timeline (Q4 2024), which may impact near-term financial expectations. The partnership with Ascensia Diabetes Care for distribution is important for market penetration. The ongoing discussions with pump manufacturers for AID system integration present additional growth opportunities but also execution risks.

Key financial metrics to monitor include adoption rates, reimbursement coverage and the impact on Senseonics' cost structure given the reduced frequency of sensor replacements.

Market Research Analyst

Eversense 365's FDA clearance could disrupt the CGM market, currently dominated by players like Dexcom and Abbott. The one-year sensor life addresses a major user pain point and could be a strong differentiator in a market valued at $19.36 billion in 2024 and expected to grow at a CAGR of 9.7% through 2030.

However, market acceptance will depend on factors like pricing strategy, insurance coverage and the comfort level of both patients and healthcare providers with the implantable technology. The Q4 2024 launch gives competitors time to respond, potentially with their own long-duration sensors.

The iCGM designation opens doors to the growing AID system market, but success will hinge on securing partnerships with established insulin pump manufacturers. Overall, Eversense 365 has the potential to reshape user expectations in the CGM space, potentially accelerating innovation across the industry.

Eversense 365 cleared in the U.S. as an integrated continuous glucose monitoring (iCGM) system for people with diabetes

With a single sensor, the Eversense 365 system provides one year of use, versus 10-14 days with short-term CGM’s for minimal life disruption

Launch expected early in the fourth quarter of 2024

GERMANTOWN, Md. and PARSIPPANY, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- 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, today announced that the U.S. Food and Drug Administration (FDA) has cleared the next-generation Eversense^® 365 CGM system for people with Type 1 and Type 2 diabetes aged 18 years and older. Eversense 365 is the world’s first One Year CGM system, representing a significant breakthrough in diabetes technology and management.

“The approval of Eversense 365 represents a significant leap in CGM innovation. Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower A1c. The delivery of the world’s first 365-day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes.”

“Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” said Brian Hansen, President of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics’ ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible. In parallel, our partnership discussions with various pump manufacturers continue to progress, as we look to leverage Eversense 365’s unique potential to simplify life with integrated automated insulin delivery (AID) systems.”

Eversense 365 is supporting people with diabetes to live life uninterrupted, as a fully-implantable, long-term CGM option that is highly-differentiated from short-term 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
  

Ascensia expects to initiate the U.S. launch of Eversense 365 U.S. in the fourth quarter of 2024, with work ongoing to transition coverage availability in order to facilitate immediate access to as many users as possible.

Eversense 365 has been cleared 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 exceptionally well suited to address common limitations⁷ of AID systems and the companies are advancing partnership discussions with various pump manufacturers.

To learn more about Eversense 365 and for additional information about when the system will be available, go to www.eversensecgm.com. Physicians, nurse practitioners and physician assistants who are interested in prescribing the Eversense CGM System can sign up at 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 Senseonics. (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

⁴ Data 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

⁶ 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

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.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements regarding plans and timing for the commercial launch of the 365-day system, statements regarding the attributes experienced by people with diabetes and differentiating the system from short-term CGM, statements regarding the potential integration with insulin pump systems, statements regarding the transition of insurer coverage, 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 execution of the independent business unit of Ascensia Diabetes Care, the Company’s commercialization partner for Eversense, and other commercial initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms with new partners and other third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 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.

Senseonics Investor Contact

Jeremy Feffer
LifeSci Advisors
investors@senseonics.com

Ascensia Communications Contact

Lorraine Chandler
Head of Corporate Communications
Lorraine.chandler@ascensia.com

FAQ

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

Eversense 365 is the world's first one-year continuous glucose monitoring (CGM) system for people with diabetes. It features a sensor that lasts for 365 days, compared to 10-14 days for short-term CGMs.

When will Senseonics (SENS) launch the Eversense 365 CGM system in the US?

Senseonics and Ascensia Diabetes Care expect to launch the Eversense 365 CGM system in the United States early in the fourth quarter of 2024.

What are the key features of the Eversense 365 CGM system?

Key features include a 365-day sensor longevity, high accuracy over 12 months, a removable transmitter, on-body vibration alerts, and compatibility with automated insulin delivery systems as an integrated CGM (iCGM).

Who is eligible to use the Eversense 365 CGM system?

The Eversense 365 CGM system is FDA-cleared for use by people with Type 1 and Type 2 diabetes aged 18 years and older in the United States.