Continuous Glucose Monitoring
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Abbott Gains From Lingo CGM's Expansion on Android Platform
ZACKS· 2025-12-15 16:41
Key Takeaways ABT rolled out Android support for Lingo, its first biowearable CGM, extending use beyond Apple devices.Lingo targets adults not on insulin, showing how diet, exercise and stress affect glucose levels in real time.Android access supports ABT's push to make CGMs a mainstream wellness tool for diabetes and prediabetes care.Abbott Laboratories (ABT) recently announced that Lingo, its first over-the-counter biowearable continuous glucose monitor system (CGM), can now be used with Android devices. ...
Senseonics Holdings, Inc. to Participate in the Stifel 2025 Healthcare Conference
Globenewswire· 2025-11-10 13:05
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].
Senseonics(SENS) - 2025 Q3 - Earnings Call Transcript
2025-11-05 22:30
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]
DexCom, Inc. (DXCM): A Bear Case Theory
Yahoo Finance· 2025-10-23 00:02
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].
Senseonics Holdings, Inc. Schedules Third Quarter 2025 Earnings Release and Conference Call for November 5, 2025 at 4:30 P.M. Eastern Time
Globenewswire· 2025-10-22 20:05
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]
American Diversified Holdings Corporation Receives $5,000,000 (Five Million) Financing Commitment from an Institutional Investment Fund
Newsfile· 2025-10-16 13:00
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]
GlucoTrack(GCTK) - Prospectus
2025-09-29 21:10
As filed with the Securities and Exchange Commission on September 29, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Glucotrack, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 3841 98-0668934 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 301 Rte. 17 ...
Senseonics Signs Memorandum of Understanding with Ascensia Diabetes Care to Take Over Commercialization and Distribution of Eversense 365
Globenewswire· 2025-09-03 21:17
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].
NorthView Acquisition (NVAC) - Prospectus(update)
2025-08-22 18:48
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 ...
NorthView Acquisition (NVAC) - Prospectus(update)
2025-08-21 20:45
As filed with the Securities and Exchange Commission on August 21, 2025. Registration No. 333-289461 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 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 ...