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Senseonics Announces European Launch of Eversense® 365, The World’s First and Only One Year CGM System

(Positive)
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Senseonics (NASDAQ: SENS) announced the European launch of Eversense 365, the world’s first one‑year implantable CGM, now available in Sweden with phased rollouts in Germany, Spain and Italy during the coming weeks. Eversense 365 doubles sensor lifespan from six months to 12 months, reduces calibrations from daily to weekly, and follows CE Mark approval in January and prior U.S. FDA approval in September 2024.

The company also highlighted real‑world evidence presented at ATTD showing sustained one‑year performance and an announced U.S. integration with Sequel Med Tech’s twiist Automated Insulin Delivery system.

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Positive

  • CE Mark approval in January 2026 enabling EU commercial launch
  • One‑year sensor life (doubles prior six‑month lifespan)
  • Calibration reduced from once daily to once weekly
  • FDA approval in September 2024 and U.S. launch in October 2024
  • Integration with Sequel Med Tech’s twiist AID system announced February 2026

Negative

  • None.

News Market Reaction – SENS

+0.71%
1 alert
+0.71% Session close to close
$292.62M Market Cap
0.0x Rel. Volume

In the Apr 24 session, SENS gained 0.71%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement extends the Eversense 365 story from prior CE Mark approval to concrete European l...
Analysis

This announcement extends the Eversense 365 story from prior CE Mark approval to concrete European launch, starting in Sweden and expanding to Germany, Spain and Italy. It reinforces the one-year CGM differentiation, reduced calibration burden, and real-world evidence of sustained performance. In context of earlier U.S. launch and AID integration, key factors to monitor include adoption trends in new EU markets, progress toward the over 30 million-patient opportunity, and any capital raises under the existing $300 million shelf.

Key Figures

Sensor lifespan: 1 year Prior sensor lifespan: 6 months Calibration frequency: Once weekly +5 more
8 metrics
Sensor lifespan 1 year Eversense 365 CGM duration per sensor
Prior sensor lifespan 6 months Eversense E3 CGM duration per sensor
Calibration frequency Once weekly Reduced from once daily calibrations
Type 1-year CGM 365 days Continuous monitoring period for Eversense 365
EU patient expansion Over 30 million patients Increase in total addressable market from Eversense 365
FDA approval date September 2024 U.S. FDA approval of Eversense 365
U.S. launch date October 2024 U.S. commercial launch of Eversense 365
AID integration date February 2026 Integration with twiist Automated Insulin Delivery System in U.S.

Historical Context

5 past events · Latest: Mar 02 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 02 Earnings and guidance Positive -18.1% Strong 2025 growth, CE Mark, U.S. AID integration, 2026 guidance and margin outlook.
Feb 19 Product integration news Positive +3.7% Full U.S. availability of twiist AID integrated with year-long Eversense 365 CGM.
Jan 29 EU approval news Positive +5.3% CE Mark approval for Eversense 365 enabling EU commercialization and AID positioning.
Jan 28 Conference participation Neutral +2.0% Announcement of participation in BTIG MedTech and Digital Health investor conference.
Jan 12 Preliminary earnings Positive -1.5% Preliminary record Q4 and 2025 revenue with strong growth and 2026 guidance.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Positive commercial and regulatory milestones often see mixed reactions: some news aligned with modest gains, while major fundamental updates, including earnings, have previously triggered sharp declines.

Recent Company History

Over recent months, Senseonics has reported strong growth, with Q4 2025 revenue of $14.3M and full-year 2025 revenue of $35.3M, plus 2026 guidance of $58–$62M and ~50% gross margin. The company secured CE Mark for Eversense 365, enabling launches in Germany, Italy, Spain, and Sweden, and rolled out U.S. AID integration with the twiist system. Earlier CE Mark approval expanded the reachable EU population by over 30 million. Today’s European launch continues that commercialization arc from U.S. deployment and integration toward broader international adoption.

Key Terms

continuous glucose monitoring, ce mark, automated insulin delivery, real-world evidence
4 terms
continuous glucose monitoring medical
"implantable continuous glucose monitoring (CGM) systems for people with diabetes"
Continuous glucose monitoring is a system that tracks blood sugar levels in real-time throughout the day and night. It provides constant updates, similar to a car's dashboard showing speed and fuel level at all times. For investors, advancements in this technology can signal progress in health monitoring devices, which may influence the growth and valuation of companies in the healthcare sector.
ce mark regulatory
"Following CE Mark approval in January, Eversense 365 is now available"
A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.
automated insulin delivery medical
"integration of Eversense 365 with Sequel Med Tech’s twiist™ Automated Insulin Delivery (AID) System"
A system that links a glucose sensor, an insulin pump, and control software so insulin is adjusted automatically to keep blood sugar near a target range, similar to a smart thermostat that regulates room temperature. It matters to investors because it replaces manual dosing with continuous, data-driven care, which can drive device sales, recurring subscription software services, better health outcomes, and regulatory interest—factors that affect market growth and company valuation.
real-world evidence medical
"This is supported by real-world evidence recently presented by Senseonics"
Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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The next-generation CGM is now available in Sweden, with launches expected in Germany, Spain and Italy during the coming weeks as part of a phased roll out

Eversense 365 doubles sensor lifespan from the previously available Eversense E3, extending the unique features and benefits of long-term implantable CGM use from six months to a full year

GERMANTOWN, Md., April 24, 2026 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NASDAQ: SENS) a medical technology company focused on the development, manufacturing and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the first European launch of the Eversense® 365 CGM system, the world’s first and only One Year CGM. Following CE Mark approval in January, Eversense 365 is now available to the first patients in Sweden, with launches to follow in Germany, Spain, and Italy during the coming weeks.

Eversense products are the only long-term CGM systems available, offering unique features and benefits for people with Type 1 and Type 2 diabetes. The next-generation Eversense 365 doubles sensor lifespan from the previously available Eversense E3, from six months to a full year, and delivers key improvements such as reducing the frequency of calibrations from once daily to once weekly.

Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics said, “this launch of Eversense 365 is a significant breakthrough for diabetes technology in Europe and for Senseonics as a business, as we successfully transition to an end-to-end commercial organization this year. Building on demonstrable commercial momentum in the U.S., European expansion is a key part of our Eversense 365 growth strategy, increasing our total addressable market by over 30 million patients.”

For the first time, certain patients in Europe will now have access to a truly differentiated CGM experience for 365 days with just one sensor. Eversense 365 provides exceptionally accurate glucose data over longer periods of time so people can focus on managing their diabetes and not their device, minimizing common frustrations caused by short term CGMsi, ii,iii:

  • Longest lasting CGM: The only CGM that lasts a year, while traditional CGMs last 10-15 days and tend to fail early.
  • No more wasted CGMs: The tiny sensor is designed to rest comfortably under the skin for a full year. Plus, the removable* smart transmitter can be taken off and put back on without wasting a CGM.
  • Alerts that can be trusted: Eversense 365 has exceptional accuracy for one year, with almost no false alerts from compression lows during sleep.
  • Maximum comfort: The gentle silicone-based adhesives are changed daily and cause almost no skin reactionsiv.

This differentiated approach is proven to empower better diabetes management and improve patient outcomes. Those who have switched to Eversense experience better health outcomes, with meaningful improvements in diabetes management, including better A1C levels and more time in their target glucose range. This is supported by real-world evidence recently presented by Senseonics at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), which demonstrated sustained performance and positive impact of Eversense 365 across a full year period.

Brian Hansen, Chief Commercial Officer of Senseonics, commented, “the excitement for Eversense 365 was palpable at ATTD and we’re thrilled to now offer this life-changing technology to the first patients in Europe. Real-world evidence showcases Eversense 365’s unique benefits – delivering one year of exceptionally accurate monitoring with minimal interruptions – enabling patients to focus on managing their diabetes and not their CGM.”

People in these European markets who are interested in understanding more about Eversense 365 can visit https://www.eversensecgm.com/ for more information.

Eversense 365 was approved by the United States Food and Drug Administration in September of 2024 and launched across the country in October of the same year. In February 2026, Senseonics announced the transformative integration of Eversense 365 with Sequel Med Tech’s twiist™ Automated Insulin Delivery (AID) System across the U.S.

About Senseonics

Senseonics Holdings, Inc. ("Senseonics") is a medical technology company focused on the development, manufacturing and commercialization 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 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

Eversense 365 is developed by Senseonics and, as the only implantable CGM available, offers patients a truly differentiated CGM experience, providing One Year of exceptionally accurate monitoring with minimal interruptions. It benefits endocrinologists and care teams by offering their patients confidence in decision making, long-term peace of mind and enhanced quality of life with just one CGM. The unique approach also allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

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/.

A media kit for Eversense 365, including images, logos and further information, can be accessed at https://www.eversensecgm.com/eversense-media-kit/.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including the statements regarding the expected launches of Eversense 365 in regions of Europe, the expected performance, benefits of using, user experience, and attributes of Eversense 365, the successful transition of the commercial organization and operations to Senseonics, expansion of European demand and the increase of the Company’s addressable market, the expanded compatibility of Eversense 365 with automated insulin delivery systems, 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: risks and uncertainties related to the transition of commercial responsibility for Eversense from Ascensia and the establishment of Senseonics’ capabilities and processes in Europe; uncertainties in insurer, regulatory and administrative processes and decisions and the finalization of new product version technology upgrades for European tenders and other customers; uncertainties in the development, registration and roll-out of new technology and solutions; uncertainties inherent in the ongoing commercialization and expansion of the Eversense product and Senseonics’ and its partners’ activities; uncertainties relating to the current economic and regulatory/political 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, 2025 and quarterly reports on Form 10-Q filed with the SEC under the heading "Risk Factors." 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.


i Senseonics. (2024) Eversense 365 CGM System User Guide.
ii Abbott. (2024) Freestyle Libre 3 User Guide ART49385-001 Rev. A 04/24
iii Dexcom (2025) G7 User Manual AW00078-10 Rev 004 MT-00078-10
iv Christiansen MP et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISEII. DIABETES TECHNOLOGY & THERAPEUTICS 2018; 20(3):197-206iv Tweden KS, et al. Implantable CGM Use Improves Glycemic Control in CGM Naive Patients. Interventions Obes Diabetes. 6(1). IOD. 000635.2023. Compared to end of SMBG phase.
* There is no glucose data generated when the transmitter is removed

Senseonics Media Contact

Tim Stamper
FTI Consulting
Tim.Stamper@senseonics.com / Eversense365@FTIConsulting.com

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


FAQ

When did Senseonics (SENS) launch Eversense 365 in Europe and where is it first available?

Eversense 365 launched in Europe on April 24, 2026, and is initially available in Sweden. According to Senseonics, phased rollouts to Germany, Spain and Italy will occur during the coming weeks.

What is the sensor lifespan and calibration schedule for Eversense 365 (SENS)?

Eversense 365 features a 12‑month implanted sensor lifespan and reduces calibrations to once weekly. According to Senseonics, this doubles prior six‑month longevity and decreases daily calibration burden for users.

Did Eversense 365 receive regulatory approvals before the European launch (SENS)?

Yes. Eversense 365 received CE Mark approval in January 2026 and had prior FDA approval in September 2024. According to Senseonics, the CE Mark enabled the current European commercialization.

What clinical or real‑world evidence supports Eversense 365 performance for SENS investors?

Real‑world evidence presented at ATTD showed sustained one‑year performance and positive impacts on diabetes management. According to Senseonics, the data demonstrated durable accuracy and patient benefits across 12 months.

How does the Eversense 365 launch affect Senseonics’ commercial strategy and market reach (SENS)?

The launch extends European commercialization and targets expansion beyond the U.S., increasing addressable market reach. According to Senseonics, the rollout and one‑year offering support its end‑to‑end commercial transition and growth strategy.