Company Overview - Senseonics has launched the full U.S. availability of its Eversense 365 Continuous Glucose Monitoring (CGM) system, integrated with Sequel Med Tech's twiist Automated Insulin Delivery (AID) system for type 1 diabetes patients [1][7] - The Eversense 365 CGM system offers a wear time of up to 365 days, significantly longer than the maximum of 15 days for other approved CGM devices from competitors like DexCom and Abbott [2][7] Financial Performance - Senseonics reported total revenues of $21 million, which is considerably lower than competitors DexCom and Abbott, who recorded $5.6 billion and $3.4 billion in sales related to CGM devices, respectively, in the first nine months of 2025 [4] - The company expects total revenues for 2026 to be in the range of $58-$62 million, representing an increase of 65% to 76% over 2025 revenue [12] Market Dynamics - The total CGM devices market size was valued at $13.66 billion in 2024 and is projected to grow at a CAGR of 15.4%, reaching $49.87 billion by 2033, driven by the rising prevalence of diabetes and technological advancements [10] - The integration of Eversense 365 with the twiist AID system is expected to enhance customer adoption and drive sales growth in 2026 [4][8] Recent Developments - Senseonics received CE Mark approval for the Eversense 365 CGM system and plans to launch it in Germany, Italy, Spain, and Sweden in the coming months [11] - The company reported a 71% year-over-year increase in total revenues for the fourth quarter of 2025, with new patients in the U.S. increasing by 103% from the previous year [12]

MANCHESTER, N.H. and GERMANTOWN, Md., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Sequel Med Tech, LLC, a company developing transformative drug delivery technologies, and Senseonics Holdings, Inc. (NASDAQ: SENS), a medical technology company focused on long-term, implantable Continuous Glucose Monitoring (CGM) systems for people with diabetes, today announced full availability of the twiist™ Automated Insulin Delivery (AID) System integrated with the Eversense® 365 CGM system across the U.S. Powered by Tidepool, twi ...

The integrated system is now being used in real-world care settings and is widely available for people with type 1 diabetesMANCHESTER, N.H. and GERMANTOWN, Md., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Sequel Med Tech, LLC, a company developing transformative drug delivery technologies, and Senseonics Holdings, Inc. (NASDAQ: SENS), a medical technology company focused on long-term, implantable Continuous Glucose Monitoring (CGM) systems for people with diabetes, today announced full availability of the twiist™ Aut ...

Senseonics Holdings (SENS) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.The po ...

Core Insights - Senseonics Holdings (SENS) shares increased by 5.3% to close at $7.33, supported by high trading volume, and have gained 26.1% over the past four weeks [1][2] Company Performance - The company achieved CE Mark approval for the Eversense 365 continuous glucose monitoring (CGM) system, which is the first one-year CGM and can integrate with compatible medical devices [2] - Senseonics is expected to report a quarterly loss of $0.43 per share, reflecting a year-over-year decline of 7.5%, while revenues are projected to be $14.2 million, representing a 71.1% increase from the previous year [3] Earnings Estimates - The consensus EPS estimate for Senseonics has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [4]

Core Insights - Senseonics Holdings, Inc. (SENS) received CE Mark approval for its Eversense 365 continuous glucose monitoring (CGM) system in Europe, marking a significant regulatory achievement [1] - The approval enhances the company's market position and growth potential, particularly in the European market, where it can leverage full commercialization rights and integration with automated insulin delivery systems [2][4] Company Developments - Following the CE Mark approval, SENS shares increased by 2.1% in the trading session, although the stock has seen a 29% decline over the past six months compared to a 21.8% decline in the industry [3] - The Eversense 365 system is the only one-year implantable CGM, which differentiates Senseonics in a competitive market, potentially leading to better pricing power and patient retention [4][9] - The company currently has a market capitalization of $278.7 million [7] Product Features - Eversense 365 addresses key issues with traditional CGMs, such as durability and reliability, with a 365-day sensor that reduces the need for frequent changes [10] - The system emphasizes accuracy, comfort, and flexibility, which are crucial for long-term adoption, and features a removable transmitter for user convenience [11][12] Industry Outlook - The global blood glucose monitoring devices market is projected to grow from $15.53 billion in 2025 to $30.18 billion by 2033, with a CAGR of 8.8% from 2026 to 2033, driven by the rising prevalence of diabetes and an aging population [13] - Senseonics reported a significant increase in third-quarter 2025 revenue, rising to $8.1 million from $4.3 million year-over-year, with U.S. revenue nearly tripling to $6.4 million [14] - The company achieved a gross profit of $3.5 million in the latest quarter, a notable improvement from a gross loss of $4.1 million a year ago, indicating progress in operational efficiency [15]

Core Viewpoint - Senseonics Holdings, Inc. has received CE Mark approval for its Eversense 365 continuous glucose monitoring (CGM) system, expanding its market reach in Europe and targeting over 30 million diabetes patients [2][3]. Group 1: Product Overview - Eversense 365 is the world's first and only one-year CGM, approved by the US FDA in September 2024 and launched in October 2024 [2]. - The system is designed to provide continuous glucose monitoring for up to 365 days, significantly reducing the need for frequent sensor changes compared to traditional CGMs [6][8]. - Eversense 365 has been cleared as an integrated CGM (iCGM) system in the US, allowing it to work with compatible medical devices, including insulin pumps [4]. Group 2: Market Expansion - The approval of Eversense 365 in the EU is expected to contribute to top-line revenue growth as the company takes full ownership of all commercial activities for the product [3]. - The company plans to launch Eversense 365 in Germany, Italy, Spain, and Sweden in the coming months [2]. Group 3: Strategic Goals - The CEO of Senseonics highlighted that 2026 will be a pivotal year for the company, focusing on commercial progress in both the US and Europe, and the integration with Sequel's twiist™ Automated Insulin Delivery System [3]. - The expansion into the European market is part of a long-term growth strategy aimed at increasing the total addressable market for the company [3]. Group 4: Product Benefits - Eversense 365 offers several advantages, including reduced data interruptions, minimal sensor replacements, and improved comfort for users [6][7]. - The system provides reliable alerts and exceptional accuracy, enhancing the user experience and quality of life for diabetes patients [6][7].

GERMANTOWN, Md., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NASDAQ: 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 that management will participate in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Wednesday, February 11, 2026 in Snowbird, Utah. To request a meeting with Senseonics, investors should co ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): January 12, 2026 SENSEONICS HOLDINGS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37717 47-1210911 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer FORM 8-K Identification No.) 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 (Addre ...

Preliminary unaudited revenue expected to be approximately $14.2 million for Q4 2025, an increase of 71% year-over-year Introduced 2026 revenue guidance of $58-$62 million Expects to report fourth quarter and full year 2025 financial results on March 2, 2026 GERMANTOWN, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NASDAQ: SENS) a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with d ...