传感器更小、佩戴更轻、算法更准，目标始终围绕 " 如何把一枚贴片戴得更久、更舒服"展开。 在连续血糖监测（CGM）领域，创新路径已经非常清晰： 但当佩戴式 CGM 的体验不断逼近极限，一个问题开始浮现： 如果真正的负担并不在"贴得好不好"，而在"是否需要反复贴"？ 01 从 FDA 到 CE：植入式 CGM 被"完整体系"接纳 2026年1月29日， Senseonics 宣布，其 Eversense 365 连续血糖监测系统 (CGM) 系统已 获得 CE 认证。 在此之前，该系统已于 2024 年 9 月获得 FDA 批准 ，成为 全球首个可在体内连续工作一整年的 CGM 。 随后，Senseonics 与其商业伙伴 Ascensia Diabetes Care 启动美国市场销售，并逐步接管该产品的全球商业化推进。 与多数 CGM 产品不同，Eversense 365 的监管难点并不在算法精度，而在 产品形态本身 ： 近期，一款 使用周期长达 365 天的植入式连续血糖监测系统 获得欧洲 CE 认证。这并不是对现有 CGM 路线的延长，而更像一次 对使用逻辑本身的重构 —— 把连续监测，从一种高频消耗的日 ...

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 ...

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 [15][18] - Gross profit was $3.5 million, an increase of $7.5 million from the prior year, primarily due to improved margins on the 365-day product sales [17] - 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 [18] Business Line Data and Key Metrics Changes - The third quarter saw a 160% increase in new patient shipments year-over-year, contributing to the overall revenue growth [5] - New insertions increased nearly 150% year-over-year and more than 50% sequentially, reflecting accelerating adoption of Eversense 365 [6] - Approximately 60% of new patients in Q3 originated from direct-to-consumer (DTC) advertising, with 40% from healthcare provider (HCP) referrals [6] Market Data and Key Metrics Changes - The number of providers actively prescribing Eversense grew by more than 55% year-over-year, indicating broadening awareness and confidence in the 365-day system [7] - Eon Care accounted for approximately one quarter of all insertions nationwide, enhancing access and standardizing patient experience [8] Company Strategy and Development Direction - The company executed a memorandum of understanding with Ascensia Diabetes Care to reassume control of Eversense commercialization, allowing for better control over strategy and investments [4] - The CE Mark application for Eversense 365 in Europe was submitted in February, with expectations for approval before the end of 2025 [8] - The company anticipates gross margins to grow to roughly 50% in 2026 and reach approximately 70% at scale for the unified business [13][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, highlighting record new patient starts and the effectiveness of DTC marketing [24] - The company expects full-year 2025 global net revenue to be approximately $35 million, with a significant portion anticipated in Q4 due to new patient starts and reorders [19][20] - Management noted that cash utilization in 2025 is expected to be approximately $60 million, with a cash balance of $111.3 million as of September 30 [22] 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 [13] - The transition from Ascensia is expected to enhance operational efficiency and improve margins [10][21] Q&A Session Summary Question: Can you discuss the 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 [28][29] Question: What is the expected timeline for the integration with Twist? - The first patients are expected to start in early Q1 2026, with a ramp-up anticipated later in the year [31][32] Question: How is the inserter network evolving? - The Eon network is crucial for expanding access, with a focus on training providers and increasing the number of inserters [36] Question: What is the status of private payers transitioning to bundled payment reimbursement? - Management expects continued transitions, with significant progress made in the first half of the year [40] Question: Can you provide an update on the CE Mark for Eversense 365? - The CE Mark application is in the final stages of review, with expectations for approval soon [72]

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 Insights - Senseonics Holdings, Inc. reported a record-setting third quarter in 2025, with total revenue of $8.1 million, marking a 90% year-over-year increase driven by a 160% rise in new patient starts in the U.S. [1][4][9] - The company is transitioning commercial responsibility for its Eversense product line back from Ascensia Diabetes Care, which is expected to enhance control over its commercialization strategy [1][3][9]. Financial Performance - Total revenue for Q3 2025 was $8.1 million, compared to $4.3 million in Q3 2024, with U.S. revenue at $6.4 million and international revenue at $1.7 million [4][9]. - Gross profit for Q3 2025 was $3.5 million, a significant improvement from a gross loss of $(4.1) million in Q3 2024, attributed to better product margins and the absence of prior year inventory write-offs [5][8]. - Research and development expenses decreased to $7.8 million from $10.5 million year-over-year, primarily due to the completion of clinical trials for the Eversense 365 system [6]. - Selling, general, and administrative expenses rose to $15.3 million from $8.3 million, driven by increased marketing and personnel costs [7]. Market Strategy and Outlook - The company anticipates receiving CE Mark approval for Eversense 365 by the end of 2025, with a European launch expected in the first half of 2026 [3]. - Senseonics expects full-year 2025 global net revenue to reach approximately $35 million, with a projected doubling of its global patient base [11]. - The company executed a 1-for-20 reverse stock split, reducing the number of outstanding shares to approximately 41 million [9][10]. Product Development - The Eversense CGM systems are designed for continuous glucose monitoring, with Eversense 365 capable of measuring glucose levels for up to 365 days [13][14]. - The company is working towards the IDE submission for its next-generation Gemini product by the end of 2025 [3].

Core Viewpoint - Senseonics Holdings, Inc. is transitioning the commercialization and distribution of its Eversense 365 continuous glucose monitoring system from Ascensia Diabetes Care to itself, aiming for improved growth and operational efficiency [1][2][3]. Group 1: Transition Details - The transition will take effect on January 1, 2026, with Senseonics assuming global sales, marketing, and commercialization responsibilities [2]. - Brian Hansen, currently President of CGM at Ascensia, will join Senseonics as Chief Commercial Officer on the same date [2]. - The companies are collaborating to finalize the documentation for this transition [2]. Group 2: Strategic Rationale - The decision to bring Eversense commercialization in-house is driven by the need for strategic investment and dedicated commercial efforts to respond to market demands [3]. - Senseonics believes that unifying the Eversense business will accelerate growth and realize its full potential more effectively than under the current structure [3]. Group 3: Financial Implications - Senseonics has expanded its non-dilutive debt facility with Hercules Capital to $100 million to fund its commercial organization [1]. - The company anticipates immediate revenue improvement and gross margin expansion to 50% in 2026, with a target of over 70% gross margins at scale [4]. - For the full year 2025, Senseonics expects global net revenue to be approximately $34-38 million, with a projected doubling of its global patient base [5][6]. Group 4: Conference Call - A conference call is scheduled for September 4, 2025, at 8:00 A.M. Eastern Time to discuss the commercial transition [1][7].

As filed with the Securities and Exchange Commission on August 22, 2025. Registration No. 333-289461 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ___________________________________ PROFUSA, INC. (Exact name of registrant as specified in its charter) ___________________________________ | Delaware | 3841 | 26-4589529 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial ...

Core Viewpoint - Luna Diabetes has successfully completed a $23.6 million Series A financing round to advance its automated insulin patch pump system, which aims to provide a more convenient and effective solution for Type 1 and Type 2 diabetes patients [1][10]. Group 1: Product and Technology Insights - The insulin patch pump differs from traditional insulin delivery methods by being lightweight and discreet, making it more suitable for daily use [5]. - The patch pump eliminates the need for infusion sets, reducing barriers to use and increasing acceptance among Type 2 diabetes patients [5]. - Luna's closed-loop system combines continuous glucose monitoring (CGM) with the insulin pump and control algorithms, aiming to minimize manual intervention and approach the functionality of an "artificial pancreas" [7]. Group 2: Capital and Industry Background - The investment from notable firms like Vensana Capital and Ascensia Diabetes Care indicates confidence in Luna's potential within the closed-loop system and overall diabetes management [10]. - The global market for insulin pumps remains underpenetrated, with less than 40% adoption among Type 1 patients in developed countries and even lower rates for Type 2 patients [11][13]. - The combination of CGM and insulin pumps is seen as a transformative solution for diabetes management, with increasing discussions around insurance coverage for these devices [13][15]. Group 3: Market Opportunities and Challenges - Luna Diabetes targets both Type 1 and Type 2 diabetes patients, significantly expanding its potential market, especially among the over 400 million Type 2 diabetes patients globally [11][12]. - The pricing and reimbursement landscape poses challenges, as traditional pumps are often expensive, but if the patch pump can be priced competitively, it could enhance market penetration [14]. - The ease of use and discreet design of the patch pump may improve patient adherence, particularly for busy Type 2 patients who prefer less visible treatment options [16]. Group 4: Future Prospects and Industry Evolution - If Luna successfully navigates clinical validation and regulatory approval, it could disrupt the dominance of traditional pump manufacturers [18]. - The evolution of diabetes treatment is moving towards integrated systems that combine devices, data, and algorithms, enhancing patient management and clinical decision-making [19]. - The development of the patch pump and closed-loop systems represents a significant shift in diabetes care, promising more convenient and precise management for patients and valuable data for healthcare providers [19].

Financial Data and Key Metrics Changes - In Q1 2025, net revenue grew 24% to $6.3 million compared to $5 million in the prior year period [18] - U.S. revenue for Q1 was $4.5 million, while revenue outside the U.S. was $1.8 million [18] - Gross profit increased to $1.5 million from $300,000 in the prior year, driven by increased margins on the Eversense three sixty five product [21] - Net loss decreased to $14.3 million or $0.02 loss per share from a net loss of $18.9 million or $0.03 loss per share in the prior year [23] Business Line Data and Key Metrics Changes - The Eversense three sixty five continuous glucose monitor (CGM) is positioned as a significant product, with a focus on integration with automated insulin delivery systems [7][9] - The company is working on expanding its Eversense three sixty five offering and has filed for CE Mark approval, anticipating a European launch in the second half of 2025 [12] - The consignment program continues to show strong utilization, contributing approximately 13% of revenue in Q1 [20] Market Data and Key Metrics Changes - The company is seeing positive responses from both U.S. and international markets, with expectations for significant growth in patient adoption [36] - The Medicare reimbursement update is expected to facilitate broader adoption of the Eversense three sixty five sensor [40] - The company anticipates doubling its global patient base in 2025 compared to 2024, with revenue expected to be approximately one-third in the first half and two-thirds in the second half of the year [26] Company Strategy and Development Direction - The company aims to transform diabetes care through technological advancements and partnerships, focusing on the integration of its CGM with insulin delivery systems [7][9] - Collaborations with companies like Sequel and Sweet Spot are part of the growth strategy to enhance patient care and streamline monitoring processes [9][10] - The company plans to continue developing its pipeline products, GEMINI and Freedom, to improve patient experience and expand its market offerings [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the launch metrics and revenue numbers, indicating a positive trajectory for the Eversense three sixty five product [29] - The company is closely monitoring the evolving tariff situation and expects to mitigate any negative impacts on gross profit margins [27] - Full-year 2025 global net revenue is projected to be approximately $34 million to $38 million, reflecting confidence in the product's market acceptance and growth potential [25] Other Important Information - The company received gross proceeds of approximately $27 million from the sale of common stock, extending its cash runway into mid-2026 [24] - As of March 31, 2025, cash and cash equivalents totaled $64.6 million, with total principal debt outstanding reduced to $35 million [23] Q&A Session Summary Question: Guidance despite Mercy contract pause - Management noted that early launch metrics for Eversense three sixty five are positive, and while the Mercy contract pause is a factor, the overall trajectory remains strong [34][36] Question: Direct-to-consumer (DTC) efforts - The company is focusing on social media channels like Facebook, TikTok, and Instagram for DTC marketing, targeting insulin users, particularly in the Medicare population [38][40] Question: Twist integration timeline - Management confirmed that integration work is ongoing, with verification and validation of the system expected to be completed by Q3 [44][46] Question: Update on commercial plans converting to three sixty five sensor - Management expects the majority of commercial plans to convert by the end of the year, with significant progress already made [47][48]

Financial Data and Key Metrics Changes - In Q1 2025, net revenue grew 24% to $6.3 million compared to $5 million in the prior year period [16] - U.S. revenue for Q1 was $4.5 million, while revenue outside the U.S. was $1.8 million [16] - Gross profit increased to $1.5 million from $300,000 in the prior year, driven by improved margins on the Eversense three sixty five product [19] - Net loss decreased to $14.3 million or $0.02 loss per share, compared to a net loss of $18.9 million or $0.03 loss per share in Q1 2024 [21] - Cash, restricted cash, and cash equivalents totaled $64.6 million as of March 31, 2025 [21] Business Line Data and Key Metrics Changes - The Eversense three sixty five product is expected to be the single product offering by the end of 2025, enhancing global supply chain synergies [11] - Approximately 13% of revenue flowed through the office consignment program, with over 100 healthcare providers participating [18] - The company is transitioning reimbursement from 180 days to 365 days for Eversense, with many payers already transitioning their coverage [12] Market Data and Key Metrics Changes - The company anticipates doubling the global patient base in 2025 compared to 2024, with revenue expected to be approximately one-third in the first half and two-thirds in the second half of the year [23] - The European launch of Eversense three sixty five is planned for the second half of 2025, pending regulatory approval [11][22] Company Strategy and Development Direction - The company is focused on transforming diabetes care through technological advancements, including collaborations with Sequel and Sweet Spot [6][7] - The integration of Eversense three sixty five with Sequel's Twist automated insulin delivery system is seen as a significant step forward [6] - Continued development of pipeline products, GEMINI and Freedom, is a priority, with plans to submit an IDE for a pivotal study by year-end [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch metrics for Eversense three sixty five, indicating strong interest and conversion rates [32] - The company expects to mitigate any negative impacts from tariffs on gross profit margins through operational changes and industry exemptions [24] - Full-year gross margins are projected to be between 25% and 30%, with expectations for steady increases each quarter in 2025 [24] Other Important Information - The company received gross proceeds of approximately $27 million from the sale of common stock, extending its cash runway into mid-2026 [22] - All preferred stock was converted into common stock, impacting the diluted earnings per share calculation [21] Q&A Session Summary Question: Guidance despite Mercy contract pause - Management noted that early launch metrics for Eversense three sixty five are positive, and while the Mercy contract pause is a concern, the overall trajectory remains strong [30][32] Question: Direct-to-consumer (DTC) efforts - The company is focusing on social media channels like Facebook, TikTok, and Instagram for DTC marketing, targeting insulin users, particularly in the Medicare population [36][38] Question: Twist integration timeline - Integration work is ongoing, with most efforts focused on verification and validation of the integrated system, expected to be completed by Q3 [41][43] Question: Update on commercial plans for reimbursement - Management expects the majority of commercial plans to convert to the 365-day sensor by the end of the year, with significant progress already made [44][45]