Core Insights - A study by Humana Healthcare Research and Yale School of Medicine indicates a significant increase in continuous glucose monitor (CGM) usage among Medicare Advantage members with type 2 diabetes from 2021 to 2023 [1] - The study highlights that CGM users often have more complex health issues compared to non-users, emphasizing the need for further research on clinical outcomes and patient access [1] Group 1: Study Findings - The proportion of Medicare Advantage members with type 2 diabetes using insulin and CGMs rose from less than 2% in January 2021 to approximately 16% by December 2023 [1] - Patients with fewer healthcare interactions and those in the oldest age group were less likely to use CGMs [1] - Patients who had an endocrinology visit in the past year were over four times more likely to use a CGM device [1] Group 2: Implications and Coverage - The growth in CGM adoption coincided with the expansion of Medicare coverage for these devices in 2023 [1] - By 2026, most individuals with a Humana Medicare Advantage plan will have access to CGMs at no out-of-pocket cost, as these devices will be fully covered [1] - The research aims to identify which patients may benefit most from CGMs, particularly those who do not frequently visit doctors, to improve health outcomes [1]

Financial Data and Key Metrics Changes - In 2025, the company achieved full-year revenue of over $35 million, growing approximately 60% year-over-year from less than $23 million in 2024 [5][27] - Gross margins improved to greater than 50% by the end of 2025, up from around 25% the previous year [5][27] - The net loss for 2025 was $69.1 million, a decrease from a net loss of $78.6 million in 2024 [27][28] Business Line Data and Key Metrics Changes - U.S. revenue for Q4 2025 was $12.1 million, while revenue outside the U.S. was $2.2 million [24] - The number of Eversense users in the U.S. more than doubled from 2024 to 2025, with new patient starts growing 103% [5][20] - The number of providers actively prescribing Eversense grew more than 80% year-over-year [21] Market Data and Key Metrics Changes - The company expects Europe to contribute about 20% of total revenue in 2026 following the launch of Eversense 365 [41] - The company anticipates full-year 2026 global net revenue to be approximately $58 million-$62 million, representing year-over-year growth of 65%-76% [28][29] Company Strategy and Development Direction - The company transitioned all commercial activities from Ascensia Diabetes Care back to Senseonics, enhancing operational efficiency and control [7][8] - The integration with Sequr Med Tech's twiist Automated Insulin Delivery System is a significant milestone, expected to simplify life for patients requiring insulin [10] - The company plans to launch Eversense 365 in several European markets in Q2 2026, with a dedicated sales force [12][106] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for 2026, driven by strategic decisions made in 2025 and the integration of commercial operations [6][32] - The company noted that Q4 is typically the strongest quarter due to insurance deductibles being met, and expects similar trends in 2026 [11][29] - Management highlighted the importance of patient retention and the effectiveness of direct-to-consumer marketing strategies [17][18] Other Important Information - The company raised capital from institutional investors and executed a reverse stock split, beginning trading on Nasdaq [10] - Research and development expenses decreased in 2025 due to the completion of clinical trials for Eversense 365 [25][28] Q&A Session Summary Question: Trends in new patient starts at the beginning of the year - Management noted that new patient growth continues as expected, with January typically being the softest month due to patient resets [37] Question: Contribution of Europe and twiist to revenue guidance - Management indicated that Europe is expected to contribute about 20% of revenue in 2026, with unique economics for each company involved in the twiist integration [39][41] Question: Seamlessness of the commercial transition from Ascensia - Management confirmed that the transition was straightforward in the U.S., with nearly 100% of employees transitioning smoothly [44] Question: Growth of the prescriber base and patient starts - Management expressed optimism about the potential for accelerated growth in the prescriber base and new patient starts, supported by increased awareness and DTC investments [50] Question: Challenges in expanding the EonCare inserter network - Management stated that the expansion is primarily dependent on volume and demand, with no significant barriers to increasing the number of inserters [81] Question: Timeline for the rollout in Europe - Management expects the transition to occur in Q2 2026, with some tenders potentially extending into early fall [105][106]

Financial Data and Key Metrics Changes - In 2025, the company achieved full-year revenue of over $35 million, growing approximately 60% year-over-year from less than $23 million in 2024 [5][25] - Gross margins improved to greater than 50% by the end of 2025, up from around 25% previously [5][24] - The net loss for 2025 was $69.1 million, a decrease from $78.6 million in 2024, indicating improved financial performance [25][26] Business Line Data and Key Metrics Changes - U.S. revenue for the fourth quarter of 2025 was $12.1 million, while revenue outside the U.S. was $2.2 million [21] - The number of patients using Eversense in the U.S. doubled, with new patient starts growing by 103% [5][18] - The active prescriber base grew more than 80% year-over-year, reflecting increased awareness and confidence in the Eversense 365 system [18] Market Data and Key Metrics Changes - The company expects Europe to contribute about 20% of total revenue in 2026, driven by the launch of Eversense 365 [40] - The company anticipates full-year 2026 global net revenue to be approximately $58 million-$62 million, representing year-over-year growth of 65%-76% [26] Company Strategy and Development Direction - The company transitioned all commercial activities from Ascensia Diabetes Care back to Senseonics, enhancing control and operational efficiency [6][9] - The integration with Sequel Med Tech's twiist Automated Insulin Delivery System is a significant milestone, expected to simplify life for patients requiring insulin [9][17] - The company plans to launch Eversense 365 in Germany, Italy, Spain, and Sweden, with a dedicated European sales force [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for 2026, supported by strategic decisions made in 2025 [12][31] - The company noted that January is typically a soft month due to patient resets, but they are seeing encouraging interest in new patient starts associated with the Sequel product [36] - Management highlighted the importance of direct-to-consumer (DTC) marketing and patient retention as key growth drivers moving forward [14][16] Other Important Information - The company raised capital from institutional investors and strategic partners, executed a reverse stock split, and began trading on Nasdaq [9] - Cash, restricted cash, and cash equivalents totaled $94.3 million as of December 31, 2025 [26] Q&A Session Summary Question: Trends in new patient starts at the beginning of the year - Management noted that new patient growth continues as expected, with January typically being the softest month due to resets, but they are seeing encouraging interest with the Sequel product [36] Question: Contribution of Europe and twiist to revenue guidance - Management indicated that they expect Europe to contribute about 20% of revenue in 2026, with the twiist product launch expected to enhance revenue [40] Question: Seamlessness of the transition from Ascensia - Management confirmed that the transition in the U.S. was straightforward, with nearly 100% of employees transitioning smoothly [43] Question: Growth of the prescriber base and patient starts - Management expressed optimism about the potential for accelerated growth in the prescriber base and new patient starts, supported by increased DTC investments [53] Question: Challenges in expanding the EonCare inserter network - Management stated that the primary factor for expanding the EonCare network is volume, and there are no significant barriers to increasing the number of inserters [80] Question: Long-term investment expectations - Management indicated that while commercial spend will continue to grow with revenue, it will not increase at the same magnitude as in 2026, and R&D expenses are expected to stabilize in the following years [83]

Group 1: Market Overview - U.S. equity markets reached new all-time highs in Q4 2025, with the S&P 500 Index rising 2.66% and the Bloomberg U.S. Aggregate Bond Index increasing by 1.10% [1] - Within the Russell 1000 Growth Index, healthcare, communication services, and financials were the top-performing sectors, while utilities, real estate, and materials lagged [1] - The U.S. economy showed resilience, but consumer confidence deteriorated toward year-end, raising concerns about future spending and the labor market [1] Group 2: Fund Performance - The Aristotle Growth Equity Fund (Class I-2) returned 0.95%, underperforming the Russell 1000 Growth Index's 1.12% [1] - Poor security selection in the information technology and consumer discretionary sectors detracted from performance, while positive contributions from healthcare and industrials improved relative performance [1] Group 3: Company Focus - DexCom, Inc. - DexCom, Inc. (NASDAQ:DXCM) is a leading medical device company specializing in continuous glucose monitoring (CGM) systems for diabetes management [2][3] - As of February 25, 2026, DexCom, Inc. stock closed at $73.16 per share, with a one-month return of -1.14% and a 52-week loss of 16.68% [2] - DexCom has a market capitalization of $28.534 billion [2] - Key products include the Dexcom G7 CGM system and Stelo Glucose Biosensor, serving users with Type 1 or Type 2 diabetes and marketed primarily to healthcare professionals [3]

Core Insights - Trinity Biotech has entered into a $25 million Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors Global to support its commercialization and innovation efforts [1][4] - The company reported revenues of $48.6 million for the trailing 12-month period ending September 30, 2025, driven by increased demand for HIV testing and operational efficiencies [2] - The CGM+ platform, a next-generation continuous glucose monitoring device, is in advanced development stages, with recent trial results confirming significant improvements [3] Funding and Financial Overview - The SEPA allows Trinity Biotech to sell up to $25 million of newly issued American Depositary Shares (ADSs) over a period of up to 36 months, providing flexibility in capital access [4] - ADS pricing under the SEPA will be set at either 97% of the lowest daily volume-weighted average price (VWAP) during a three-day pricing period or 95% of the VWAP during a single-day pricing period [5] Product Development and Innovation - The CGM+ platform features a redesigned needle-free glucose sensor that eliminates the need for finger-stick calibration, enhancing its commercial viability [3] - The company is also developing other innovative technologies, including Epicapture for cancer monitoring and a metabolomics-based diagnostic platform [3][9]

As filed with the Securities and Exchange Commission on February 13, 2026 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PROFUSA, INC. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Delaware 3841 86-3437271 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (I.R.S. Employer Identification Number) 626 Bancroft Way, Suite A Berkeley, CA 94710 (925) 997-6925 (Address, including zip code, and telephone number, incl ...

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].

Core Viewpoint - Senseonics Holdings, Inc. is actively participating in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference, indicating its commitment to engaging with investors and stakeholders in the medical technology sector [1]. Company Overview - Senseonics Holdings, Inc. specializes in the development and manufacturing of long-term implantable continuous glucose monitoring (CGM) systems aimed at improving the lives of individuals with diabetes [3]. - The company's CGM systems, Eversense® 365 and Eversense® E3, feature a small sensor that is fully implanted under the skin and communicates with a smart transmitter worn externally, providing glucose data to a mobile app every 5 minutes [3]. Investor Relations - Investors interested in meeting with Senseonics during the conference are encouraged to contact their BTIG representatives for arrangements [2]. - The investor contact for Senseonics is Jeremy Feffer from LifeSci Advisors, who can be reached via the provided email [4].

Core Insights - Senseonics Holdings, Inc. reported preliminary unaudited revenue of approximately $14.2 million for Q4 2025, marking a 71% increase year-over-year [1][5] - The company introduced revenue guidance for 2026, estimating global net revenue to be between $58 million and $62 million, which represents a growth of 65% to 76% compared to 2025 [4] - The company plans to report its full-year 2025 financial results on March 2, 2026 [1][6] Financial Performance - The total revenue for the full year 2025 is expected to be approximately $35.2 million, reflecting a 57% increase year-over-year [5][6] - The unaudited balance of cash, cash equivalents, and restricted cash as of December 31, 2025, is projected to be around $94.3 million [5] Business Developments - The company achieved a 103% growth in new patients in the U.S. during Q4 2025 compared to the same period in 2024, driven by direct-to-consumer marketing efforts [6] - Senseonics secured FDA Investigational Device Exemption (IDE) approval to commence a pivotal trial for the Gemini sensor and has enrolled the first patients [6] - The transition of commercialization and distribution rights for Eversense 365 from Ascensia is expected to enhance revenue and gross margins starting January 1, 2026 [3][4] Future Outlook - The company anticipates a boost in revenue from the expected CE mark approval in Europe for Eversense 365 and the launch of the twiist system with full Eversense compatibility [3] - The completion of the Gemini trial is expected in the second half of 2026, contributing to future growth [3]

Core Insights - Abbott Laboratories (ABT) has launched Lingo, its first over-the-counter biowearable continuous glucose monitor (CGM), for Android devices, significantly expanding its user base [2][8] - Lingo targets adults not on insulin, helping them understand how diet, exercise, and stress affect their blood sugar levels, thereby promoting healthier lifestyle choices [3][4] - The introduction of Android support aligns with Abbott's strategy to position CGMs as mainstream wellness tools for diabetes and prediabetes management [3][6] Company Developments - The rollout of Lingo on Android devices enhances its scalability, allowing Abbott to reach a larger audience and remove previous limitations tied to device compatibility [9] - Lingo features user-friendly tools like Lingo Count, which helps users track glucose spikes and improve metabolic health over time [9] - Abbott has reported that users who decrease their Lingo Count can halve the time spent above healthy glucose levels and reduce average glucose by 10% within three months [9] Market Position and Trends - Abbott's market capitalization stands at $218.16 billion, reflecting its strong position in the healthcare sector [7] - The CGM device market is projected to reach $5.74 billion by 2025, with a compound annual growth rate (CAGR) of 7.1% through 2034, driven by the rising prevalence of diabetes and demand for preventive measures [12] - Abbott's strategic focus on metabolic awareness positions it well to capitalize on the growing consumer interest in preventing prediabetes and related health conditions [11]