Senseonics Completes CE Mark Submission for Eversense 365, World’s Longest-lasting Continuous Glucose Monitor
Senseonics Holdings (NYSE: SENS) has submitted a CE Mark registration for its Eversense 365 CGM system, the world's first one-year continuous glucose monitoring system. The device, already FDA-approved and launched in the US in October 2024, could soon be commercialized across EU member countries through Ascensia Diabetes Care.
The Eversense 365 system offers significant advantages over traditional short-term CGMs, including: year-long duration, removable smart transmitter, trusted alerts with exceptional accuracy, comfortable silicone-based adhesives, and weekly calibration requirements. Following CE Mark approval, the company plans distribution in Germany, Italy, Spain, Poland, Switzerland, and Sweden.
The system is cleared in the US as an integrated CGM (iCGM) system, compatible with insulin pumps for automated insulin delivery (AID) systems, with ongoing partnership discussions with pump manufacturers.
Senseonics Holdings (NYSE: SENS) ha presentato una registrazione per il Marchio CE per il suo sistema CGM Eversense 365, il primo sistema di monitoraggio continuo della glicemia della durata di un anno al mondo. Il dispositivo, già approvato dalla FDA e lanciato negli Stati Uniti nell'ottobre 2024, potrebbe essere commercializzato presto in tutti i paesi membri dell'UE tramite Ascensia Diabetes Care.
Il sistema Eversense 365 offre vantaggi significativi rispetto ai tradizionali CGM a breve termine, tra cui: durata annuale, trasmettitore smart rimovibile, avvisi affidabili con un'eccezionale precisione, adesivi confortevoli a base di silicone e requisiti di calibrazione settimanali. Dopo l'approvazione del Marchio CE, l'azienda prevede di distribuire in Germania, Italia, Spagna, Polonia, Svizzera e Svezia.
Il sistema è autorizzato negli Stati Uniti come sistema CGM integrato (iCGM), compatibile con pompe per insulina per sistemi di somministrazione automatica di insulina (AID), con discussioni in corso su partnership con i produttori di pompe.
Senseonics Holdings (NYSE: SENS) ha presentado un registro de Marca CE para su sistema de CGM Eversense 365, el primer sistema de monitoreo continuo de glucosa de un año en el mundo. El dispositivo, ya aprobado por la FDA y lanzado en EE. UU. en octubre de 2024, podría comercializarse pronto en todos los países miembros de la UE a través de Ascensia Diabetes Care.
El sistema Eversense 365 ofrece ventajas significativas sobre los CGMs tradicionales a corto plazo, incluyendo: duración de un año, transmisor inteligente removible, alertas confiables con una precisión excepcional, adhesivos cómodos a base de silicona y requisitos de calibración semanales. Después de la aprobación de la Marca CE, la empresa planea distribuir en Alemania, Italia, España, Polonia, Suiza y Suecia.
El sistema está aprobado en EE. UU. como sistema CGM integrado (iCGM), compatible con bombas de insulina para sistemas de entrega automatizada de insulina (AID), con discusiones en curso sobre asociaciones con fabricantes de bombas.
센소닉스 홀딩스 (NYSE: SENS)는 에버센스 365 CGM 시스템의 CE 마크 등록을 제출했습니다. 이 시스템은 세계 최초의 1년 연속 혈당 모니터링 시스템입니다. 이 장치는 이미 FDA 승인을 받고 2024년 10월 미국에서 출시되었으며, 곧 Ascensia Diabetes Care를 통해 EU 회원국에서 상용화될 가능성이 있습니다.
에버센스 365 시스템은 전통적인 단기 CGM에 비해 여러 가지 중요한 장점을 제공합니다. 여기에는 연간 지속시간, 탈부착 가능한 스마트 송신기, 신뢰할 수 있는 경고와 뛰어난 정확도, 편안한 실리콘 기반 접착제 및 주간 교정 요구 사항이 포함됩니다. CE 마크 승인을 받은 후, 회사는 독일, 이탈리아, 스페인, 폴란드, 스위스 및 스웨덴에서 유통할 계획입니다.
이 시스템은 미국에서 통합 CGM(iCGM) 시스템으로 승인되었으며, 자동 인슐린 전달(AID) 시스템을 위한 인슐린 펌프와 호환됩니다. 현재 펌프 제조업체와의 파트너십 논의가 진행 중입니다.
Senseonics Holdings (NYSE: SENS) a soumis une demande de certification CE pour son système CGM Eversense 365, le premier système de surveillance continue de la glycémie d'une durée d'un an au monde. Le dispositif, déjà approuvé par la FDA et lancé aux États-Unis en octobre 2024, pourrait bientôt être commercialisé dans tous les pays membres de l'UE par le biais d'Ascensia Diabetes Care.
Le système Eversense 365 offre des avantages significatifs par rapport aux CGMs traditionnels à court terme, notamment : une durée d'un an, un émetteur intelligent amovible, des alertes fiables avec une précision exceptionnelle, des adhésifs confortables à base de silicone et des exigences de calibration hebdomadaires. Suite à l'approbation du Marquage CE, l'entreprise prévoit une distribution en Allemagne, en Italie, en Espagne, en Pologne, en Suisse et en Suède.
Le système est approuvé aux États-Unis en tant que système CGM intégré (iCGM), compatible avec les pompes à insuline pour les systèmes de livraison d'insuline automatisée (AID), avec des discussions de partenariats en cours avec les fabricants de pompes.
Senseonics Holdings (NYSE: SENS) hat eine CE-Zulassung für sein Eversense 365 CGM-System eingereicht, das weltweit erste System zur kontinuierlichen Glukoseüberwachung mit einer Dauer von einem Jahr. Das Gerät, das bereits von der FDA genehmigt wurde und im Oktober 2024 in den USA auf den Markt kam, könnte bald in allen EU-Mitgliedstaaten über Ascensia Diabetes Care kommerzialisiert werden.
Das Eversense 365-System bietet erhebliche Vorteile gegenüber herkömmlichen kurzfristigen CGMs, darunter: eine jährliche Dauer, abnehmbaren Smart-Transmitter, vertrauenswürdige Warnungen mit außergewöhnlicher Genauigkeit, bequeme, silikonbasierte Klebstoffe und wöchentliche Kalibrieranforderungen. Nach der CE-Zulassung plant das Unternehmen den Vertrieb in Deutschland, Italien, Spanien, Polen, der Schweiz und Schweden.
Das System ist in den USA als integriertes CGM (iCGM) genehmigt und mit Insulinpumpen für automatisierte Insulinabgabesysteme (AID) kompatibel, wobei laufende Partnerschaftsgespräche mit Pumpenherstellern stattfinden.
- FDA approval and successful US launch of Eversense 365 CGM system in 2024
- Product advantages over competitors: 1-year duration vs traditional 10-14 days
- Potential market expansion into six European countries pending CE Mark approval
- iCGM certification enabling integration with insulin pumps for AID systems
- CE Mark approval still pending, creating uncertainty for European expansion
- Weekly calibration requirement may be seen as a disadvantage
- No glucose data generated when transmitter is removed
Insights
The CE Mark submission for Eversense 365 marks a pivotal expansion opportunity for Senseonics in the $5.5 billion European CGM market. The device's unprecedented one-year sensor life represents a paradigm shift in the CGM landscape, where current competitors like Dexcom and Abbott require sensor changes every 10-14 days.
The targeted initial launch in six key European markets (Germany, Italy, Spain, Poland, Switzerland and Sweden) is strategically sound, as these countries represent approximately 70% of the addressable CGM market in Europe. Germany, in particular, has favorable reimbursement policies for innovative diabetes technologies.
The existing partnership with Ascensia Diabetes Care provides established distribution channels and relationships with healthcare providers, which should facilitate market penetration. The positive feedback from the US launch suggests strong product-market fit, though European adoption patterns may differ due to varying healthcare systems and reimbursement structures.
A critical growth catalyst lies in the device's iCGM designation and potential AID system integration. The European market has shown strong adoption of insulin pump therapy, making AID compatibility a significant competitive advantage. Successful partnership agreements with pump manufacturers could substantially expand the addressable market.
The weekly calibration requirement, while more convenient than daily calibrations, may face competition from factory-calibrated systems. However, the one-year implant duration offers compelling cost advantages and could drive favorable reimbursement decisions from European payers.
The Eversense 365 system embodies several breakthrough technological innovations that address critical limitations of traditional CGMs. The implantable sensor's fluorescence-based glucose detection technology enables superior accuracy and stability compared to traditional enzymatic sensors, maintaining performance throughout the entire 365-day period.
The system's architecture, featuring a removable smart transmitter and under-skin sensor, represents an elegant solution to the adhesive fatigue and sensor failure issues that plague traditional CGMs. The daily replacement of gentle silicone-based adhesives significantly reduces skin irritation, a common complaint with existing systems.
A key technological differentiator is the system's compression low prevention capability, addressing a significant source of false alarms in current CGMs. This feature, combined with the weekly calibration protocol, optimizes the balance between accuracy and user convenience.
The iCGM designation demonstrates the system's robust interoperability capabilities, essential for integration into broader digital health ecosystems. This positions Eversense 365 favorably in the evolving landscape of connected diabetes care solutions, particularly as AID systems become more prevalent in clinical practice.
GERMANTOWN, Md., Feb. 06, 2025 (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, 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 removed
1Senseonics. (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.
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 Contact
Jeremy Feffer
LifeSci Advisors
investors@senseonics.com
FAQ
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