Key Takeaways SENS launched Eversense 365 with twiist, the first one-year implantable CGM integrated with an AID system.The SENS integration reduces sensor changes while enabling automated, real-time insulin dosing for users.SENS said first commercial patients are using the system, with broad availability expected by March 2026.Senseonics Holdings, Inc. (SENS) recently reached an important commercialization milestone with the launch of its Eversense 365 continuous glucose monitor (CGM) integrated with the t ...

Speaking about Dexcom's approach, Maite Penalba, President of the Association for Diabetes Educators, Valencia, added: "Through Dexcom Academy, healthcare professionals can access training that offer us certification, that we can manage at our own pace, and that add value because they are based on real case studies. "The courses not only facilitate an understanding of the [CGM] system's features but can also be practically applied in consultations with people with diabetes. Dexcom Academy is an opportunity ...

Core Insights - DexCom has received FDA clearance for its CGM-integrated basal insulin dosing optimizer, Dexcom Smart Basal, specifically for adults with Type 2 diabetes using glargine U-100 long-acting insulin therapy [1][8] - The software will utilize data from DexCom's G7 15 day CGM sensor to provide personalized daily insulin dose recommendations, enhancing the effectiveness of long-acting insulin therapy [2][9] - Despite the FDA clearance, DexCom's stock has declined by 23.2% this year, contrasting with the industry's growth of 0.6% and the S&P 500's gain of 13.5% [3] Product Details - Dexcom Smart Basal is the first titration software that integrates with a CGM sensor to optimize basal insulin doses, starting with an initial dose set by healthcare providers [1][6] - The software analyzes CGM readings to provide personalized recommendations, adjusting doses based on glucose levels and offering alerts for low glucose to prevent hypoglycemic episodes [9][10] - The feature is expected to improve adherence to insulin therapy and reduce the workflow for healthcare providers by minimizing manual input and office visits [10] Market Performance - Following the FDA clearance, DexCom's stock fell by 0.7% on November 19, indicating ongoing pressure on gross margins despite the positive regulatory news [3][4] - The introduction of Dexcom Smart Basal is anticipated to boost demand for the G7 15 day sensor among Type 2 diabetes patients [4] Competitive Landscape - DexCom currently holds a Zacks Rank of 3 (Hold), while other medical stocks like Medpace Holdings, Globus Medical, and Masimo have higher rankings, indicating stronger performance in the market [11] - Medpace has shown a significant earnings growth rate of 17.1% for 2025, outperforming the industry average of 16.6% [12] - Globus Medical and Masimo also reported strong earnings, with adjusted EPS exceeding consensus estimates, highlighting competitive performance in the medical sector [12][13]

Market Overview - The US equity market experienced a rally in the third quarter of 2025, with the S&P 500 Index increasing by 8.12% [1] - Bonds also performed well, with the Bloomberg U.S. Aggregate Bond Index rising by 2.03% during the same period [1] Performance Analysis - The composite return for the quarter was 7.22% gross of fees and 7.10% net of fees, which underperformed the S&P 500 Index's gain of 8.12% [1] - The underperformance of the strategy was attributed to security selection [1] Company Spotlight: DexCom, Inc. - DexCom, Inc. specializes in continuous glucose monitoring (CGM) systems for diabetes management and has developed innovative technology, including a small implantable device for glucose level measurement [3] - The company's products, such as the Dexcom G7 CGM system and the Stelo Glucose Biosensor, are designed for both adults and children with type 1 or type 2 diabetes, as well as adults with prediabetes and type 2 diabetes who do not use insulin [3] - As of November 13, 2025, DexCom's stock closed at $59.72 per share, with a market capitalization of $23.292 billion [2] - Over the last month, DexCom's stock experienced a return of -10.33%, and its shares lost 21.30% of their value over the past 52 weeks [2]

Company Overview - Insulet's 2024 revenue reached $2.1 billion[21] - The company has over 500,000 active Podders globally[21] - Approximately 365,000 users are utilizing Omnipod 5[21] Financial Performance and Growth - The company is growing revenue beyond $2.5 billion[25] - The company anticipates approximately 24% compound annual growth rate (CAGR)[25] - The company is experiencing greater than 660 basis points (bps) expansion in leading gross margin[25] - The company is experiencing approximately 1,010 bps expansion in adjusted operating margin[25] Omnipod 5 Impact and Market - Omnipod 5 demonstrated a 20%-23% increase in time in range for adults with Type 1 and Type 2 diabetes, respectively[28] - The company estimates a total addressable market of approximately 14 million patients[41] - U S Type 1 Diabetes market penetration is approximately 40%[40]

Core Insights - DexCom, Inc. (DXCM) reported third-quarter 2025 adjusted earnings per share (EPS) of 61 cents, exceeding the Zacks Consensus Estimate of 57 cents by 7%, and up from 45 cents in the prior-year quarter [1] - Total revenues increased by 21.6% year-over-year to $1.21 billion, surpassing the Zacks Consensus Estimate by 2.7%, driven by strong demand and recent access wins, particularly in type 2 diabetes [2][7] - Despite positive results, DXCM shares fell nearly 12.8% in after-hours trading on October 30, with a year-to-date decline of 12.3% compared to a 1.6% decline in the industry [3] Revenue Details - Sensor and other revenues, which account for 97% of total revenues, rose by 23% year-over-year to $1.18 billion, while hardware revenues decreased by 19% to $34.2 million [4] - U.S. revenues, making up 70% of total revenues, increased by 21% year-over-year to $851.9 million, and international revenues improved by 22% to $316.1 million [5] Margin and Operating Income - Adjusted gross profit reached $741.3 million, a 23.2% increase from the prior-year quarter, with an adjusted gross margin of 61.3%, down 160 basis points year-over-year [8] - Total adjusted operating income was $272.9 million, up 28.7% from the previous year, with an adjusted operating margin of 22.6%, an increase of 130 basis points year-over-year [9] Financial Position - At the end of the third quarter, DexCom had cash, cash equivalents, and marketable securities totaling $3.32 billion, up from $2.93 billion in the second quarter of 2025, with total assets amounting to $7.5 billion [10] 2025 Guidance - DexCom raised its revenue guidance for 2025 to a range of $4.63-$4.65 billion, implying a 15% year-over-year growth, with an expected adjusted gross margin of approximately 61% and an adjusted operating margin of 20-21% [11] Market Position and Growth Drivers - The company is experiencing strong momentum in the U.S. market, particularly among the type 2 diabetes population, supported by broader primary-care reach and expanding commercial coverage [13] - International growth has accelerated, with notable performance in France and Canada due to recent reimbursement wins [13] - DexCom is preparing for the rollout of its 15-day G7 sensor and enhancing its software ecosystem, which includes a new Smart Basal titration module [14] Customer Experience and Market Expansion - The company is focusing on improving customer experience through the My DexCom Account portal and enhancing product features, which are expected to boost user satisfaction [17] - With broad pharmacy benefit manager (PBM) coverage extending to approximately six million non-insulin type-2 U.S. lives, DexCom aims to unlock a market of over 25 million Americans [18]

Core Viewpoint - DexCom's shares have underperformed the broader market in 2025, down 11% year to date, primarily due to legal and regulatory challenges impacting its performance [1][8] Financial Performance - Despite the stock's decline, DexCom's financial results have been strong, with expectations for continued growth in the upcoming quarterly update on October 30 [2][6] - The company's guidance for fiscal 2025 indicates a year-over-year revenue growth of approximately 14% to 15%, which is critical for maintaining investor confidence [6] Product and Market Position - DexCom is a leading player in the continuous glucose monitoring (CGM) market, with its latest device, the G7, launched in the U.S. in 2023 [3][7] - Some patients have reported issues with inaccurate readings from the G7 device, leading to class action lawsuits, although the majority of customers are still using older G6 devices [4][6] Regulatory Challenges - The company received a warning letter from the U.S. Food and Drug Administration regarding manufacturing issues, which negatively impacted its stock price [5][8] - Monitoring how DexCom addresses these regulatory challenges will be crucial in the upcoming quarterly update [6] Competitive Landscape - DexCom faces competition from Abbott Laboratories, which has also experienced quality control issues with its FreeStyle Libre device, yet remains a significant growth driver for Abbott [7]

Core Viewpoint - DexCom, Inc. is expected to report strong third-quarter results, driven by operational momentum, patient growth, and improved access, with a raised full-year revenue outlook reflecting confidence in demand and reimbursement expansion [1][2][8] Operational Performance - The company enters Q3 with solid operational momentum, supported by continued patient growth and a strengthening global footprint [2][8] - Commercial execution is a focal point, with healthy uptake of the product portfolio, particularly G7 and Stelo, despite competitive pressures [3][8] - Improved channel operations and access expansion are likely to have contributed to stronger prescription trends and pharmacy channel throughput [4][6] U.S. Market Dynamics - Strong new patient additions and integration with over 100 health systems have supported smoother prescription workflows [4][5] - Coverage for Type 2 diabetes patients not on insulin has broadened, with access secured through a major PBM, potentially covering around six million lives [4][5] International Trends - The international business has maintained healthy growth, driven by expanding Type 2 access and market penetration in regions like Ontario, France, and Japan [7][10] - Management expects continued international contribution, supported by growing awareness among primary care providers and improving prescription visibility [9][10] Stelo and New Market Initiatives - Stelo is an emerging growth vector, with over 400,000 app downloads and partnerships enhancing user engagement [11][12] - While currently a small financial contributor, Stelo is expected to represent 2% to 3% of 2025 sales, with ongoing feature expansion likely to accelerate adoption [12] Financial Outlook and Margin Progress - The company raised its full-year 2025 revenue outlook to $4.60 to $4.625 billion, reflecting 14% to 15% growth [13] - Gross margin is projected at approximately 62%, with expectations for sequential improvement as freight costs ease and inventory levels normalize [13][14] Estimate Picture - The Zacks Consensus Estimate for Q3 revenues is $1.18 billion, indicating an 18.4% improvement year-over-year, with EPS expected to increase by 26.7% to 57 cents [15] Long-Term Investment Visibility - Dexcom's long-term growth is supported by the expansion of the CGM category into Type 2 and pre-diabetes markets, with improving coverage and digital workflow integration [24][25] - Innovation remains central to the strategy, with advancements in product offerings and software enhancing usability and user engagement [25][26]

As filed with the Securities and Exchange Commission on October 9, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PROFUSA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3841 26-4589529 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 626 Bancroft Way Suite A Berkeley, CA 94710 (925 ...

Company Overview - Trinity Biotech plc (TRIB) is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [2] Key Developments - Trinity Biotech announced positive clinical trial results for its next-generation continuous glucose monitoring (CGM) technology, CGM+, confirming accurate glucose readings over a 15-day wear period without finger-stick calibration [1][8] - The redesigned proprietary needle-free glucose sensor reduces disposable components, significantly lowering the cost of care compared to current leading market products [1][8] - The CGM+ platform is designed to enhance accessibility and increase utilization of CGM technology, addressing the high cost of existing devices that hinders widespread adoption [3] Technical Achievements - The elimination of finger-stick calibration is considered the most significant technical achievement for TRIB, aligning its glucose sensor with market leaders while offering a differentiated product that is more affordable, reusable, and sustainable [4] Market Potential - The global CGM market is projected to grow from $13 billion in 2025 to $28 billion by 2030, driven by rising diabetes prevalence and demand for real-time health data, which is expected to provide a significant boost to Trinity Biotech's business [5] Product Development - Trinity Biotech unveiled its new flagship product, CGM+, which is positioned for the $260 billion AI wearables market and combines multi-sensor data with real-time analytics to meet the demands of AI-powered healthcare [6] Competitive Landscape - Medtronic plc (MDT) and Abbott Laboratories (ABT) are notable peers in the diabetes management space, with both companies making advancements in CGM technology and reporting robust growth in their respective diabetes care segments [7][9] - DexCom, Inc. (DXCM) also reported strong revenue growth and received FDA clearance for its Dexcom G7 15 Day CGM System, showcasing extensive clinical evidence for its usage in various diabetes conditions [10]