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].

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 ...

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 ...

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]

Core Insights - Senseonics Holdings, Inc. is set to participate in the Stifel 2025 Healthcare Conference, indicating its active engagement in the healthcare investment community [1][2]. Company Overview - Senseonics is a medical technology company that specializes in developing and manufacturing 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]. Event Details - The Stifel 2025 Healthcare Conference will take place on November 12, 2025, at 4:40 pm ET, featuring a fireside chat format and one-on-one meetings [2]. - Interested parties can access a live and recorded webcast of the presentation through the company's website [2].

Financial Data and Key Metrics Changes - In Q3 2025, net revenue grew by 90% to $8.1 million compared to $4.3 million in the prior year period, driven by Eversense 365 US revenue of $6.4 million and $1.7 million from outside the US [17][20][24] - Gross profit was $3.5 million, an increase of $7.5 million from the prior year, primarily due to improved margins on 365-day product sales [18][19] - Net loss decreased to $19.5 million, or $0.43 loss per share, compared to a net loss of $24 million, or $0.77 loss per share in Q3 2024 [20] Business Line Data and Key Metrics Changes - Revenue growth was driven by a 160% increase in new patient shipments year-over-year, with new insertions increasing nearly 150% year-over-year [5][6] - Approximately 60% of new patients in Q3 originated from direct-to-consumer (DTC) advertising, with 40% from healthcare provider (HCP) referrals [6][8] - The number of providers actively prescribing Eversense grew by more than 55% year-over-year, with 75 new trained inserters added, representing a 140% increase from the same time last year [8][9] Market Data and Key Metrics Changes - The installed base of Eversense grew over 150% year-over-year and nearly 40% sequentially, reflecting accelerating adoption among patients and providers [6][8] - The DTC campaign led to a 300% increase in patient leads year-over-year and an 85% increase sequentially [5][6] - The company anticipates that the transition from Ascensia will allow it to recognize 100% of revenues, which is expected to positively impact future revenue growth [18][20] Company Strategy and Development Direction - The company executed a memorandum of understanding with Ascensia Diabetes Care to reassume control of Eversense commercialization, allowing for greater control over strategy and investments [4][10] - The company plans to continue investing in DTC marketing, primarily through social media, to drive demand and awareness [6][8] - Future product development includes the anticipated CE Mark approval for Eversense 365 in Europe, expected before the end of 2025, and the launch planned for the first half of 2026 [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, citing significant new patient additions and top-line growth due to expanding awareness and adoption of Eversense 365 [25][26] - The company expects full-year 2025 global net revenue to be approximately $35 million, with a strong Q4 anticipated due to new patient starts and reorders from first US 365 patients [20][22] - Management highlighted margin improvements, projecting gross profit margins to grow to roughly 50% in 2026 and approximately 70% at scale [14][23] Other Important Information - The company is focused on expanding access to its unique system and advancing technology to simplify glucose testing for people with diabetes [14][25] - The transition to resume control of Eversense commercialization is progressing well, with nearly all employees from Ascensia's US CGM business electing to join Senseonics [11][12] Q&A Session Summary Question: Follow-up on growth opportunities in DTC - Management noted a significant increase in switchers from existing CGM systems, with 90% of new patients coming from this group, primarily from Dexcom and Libre [30][31] Question: Integration with Twist insulin delivery system - The first patients are expected to start in early Q1 2026, with a ramp-up anticipated later in the year [32][34] Question: Update on inserter network evolution and reimbursement - The EonCare model is expanding, with a focus on primary care and Medicare patients, and the company is seeing growth in providers interested in institutionalizing the insertion process [38][40] Question: Update on private payers and bundled payment reimbursement - Management expects continued transitions among private payers, with significant progress made in the first half of the year [42][44] Question: Details on DTC marketing spend and its effectiveness - Increased DTC spending has shown a direct correlation with patient acquisition, though there is a need for education and conversion [62][63] Question: Revenue guidance and inventory dynamics for 2026 - The company anticipates some inventory dynamics affecting revenue recognition in 2026, but remains on track for patient growth [55][66]

Core Viewpoint - The investigation by Hunterbrook Media highlights significant safety, operational, and financial concerns regarding DexCom, Inc.'s G7 continuous glucose monitor, indicating a decline in the company's reputation and potential risks to patient health [2][5]. Financial Performance - DexCom's share price was $65.41 as of October 15th, with trailing and forward P/E ratios of 46.79 and 25.64 respectively [1]. - Financial indicators suggest deteriorating fundamentals, including a surge in days sales outstanding and a doubling of work-in-process inventory, raising concerns about revenue recognition practices [4]. Product Issues - The G7 sensor's performance has been compromised due to a secret alteration of a key component, leading to underperformance in accuracy metrics and resulting in the FDA classifying the device as "adulterated" [2][3]. - Users have reported serious inaccuracies, leading to hospitalizations and fatalities, including a case linked to a device failure [2][3]. Corporate Culture and Management - Former employees have criticized the corporate culture for prioritizing profit margins over safety, with inadequate technical oversight and rushed design decisions to compete with Abbott's Freestyle Libre 3 [3]. - There are indications of systemic issues within the company, evidenced by executive departures, insider sales, and repeated product recalls [4]. Competitive Landscape - DexCom faces increasing competition from Abbott's superior devices and potential changes in Medicare policies, which could threaten its market share [4]. - The company's own initiatives, such as the Stelo device, are also experiencing accuracy problems and legal challenges [4].

Core Insights - Senseonics Holdings, Inc. is set to release its third quarter 2025 financial results on November 5, 2025, after market close [1] - A conference call to discuss the financial performance will take place at 4:30 p.m. Eastern Time on the same day, with a webcast available for investors [2] Company Overview - Senseonics is a medical technology company specializing in long-term implantable continuous glucose monitoring 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 implanted under the skin and communicates with a smart transmitter, sending glucose data to a mobile app every 5 minutes [3]

Investment Commitment - A prominent institutional investment fund has committed to providing up to $5,000,000 in financing to American Diversified Holdings Corporation (ADHC) [1][2] Use of Funds - The investment proceeds are designated for the research and development of the GlucoGuard project and for general corporate purposes, as well as to support collaboration with DexCom, a Continuous Glucose Monitoring (CGM) development partner [2] FDA Interaction - ADHC has engaged with its Medical Advisory Board and the FDA, leading to a request for a two-prong sleep study to address safety and efficacy concerns regarding the GlucoGuard device [3] FDA Review - The major components of the Breakthrough Device Application Designation have received positive feedback from the FDA regarding the unmet need and GlucoGuard's potential to assist patients [4] Company Mission - The investment is expected to enhance ADHC's valuation and support its mission to help Type 1 Diabetics manage hypoglycemic events, thereby improving patients' lives [5]