Automated Insulin Delivery
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Beta Bionics, Inc. Q4 2025 Earnings Call Summary
Yahoo Finance· 2026-02-18 13:30
Achieved $100.3 million in 2025 net sales, representing 54% year-over-year growth driven by a doubling of the installed base to 35,000 users. Attributed sales force productivity to the iLet's fully automated algorithm and digital ecosystem, which allowed a smaller team of 63 territories to compete effectively against larger incumbents. Successfully executed a pharmacy channel strategy, establishing formulary agreements with all major U.S. PBMs to lower patient out-of-pocket costs and drive high-margin ...
Dexcom (NasdaqGS:DXCM) Earnings Call Presentation
2026-02-12 12:00
Investor Presentation February 12, 2026 CONFIDENTIAL – DO NOT DISTRIBUTE Safe harbor statement This presentation contains "forward-looking statements" that are based on our management's beliefs and assumptions and on information available to management as of February 12, 2026. We intend for such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include inform ...
Medtronic Diabetes expands access to full-stack insulin delivery solutions with Medicare access and new FDA clearances
Prnewswire· 2026-02-02 14:17
Core Insights - Medtronic announced three significant milestones in the U.S. aimed at expanding access and flexibility for individuals with type 1 and insulin-requiring type 2 diabetes, including Medicare access for the MiniMed™ 780G system with the Instinct sensor, FDA clearance for its use with ultra rapid-acting insulins, and clearance for use with insulin-requiring type 2 diabetes [1][2][6]. Group 1: Medicare Access - Medicare beneficiaries can now access the MiniMed™ 780G system paired with the Instinct sensor, which is small, thin, and can be worn discreetly for up to 15 days [3][5]. - This milestone enhances sensor choice for Medicare users, who also have access to the Simplera Sync™ and Guardian™ 4 sensors [3]. Group 2: FDA Clearances - The FDA has cleared the MiniMed™ 780G system for use with ultra rapid-acting insulins, such as Fiasp and Lyumjev, providing more flexibility and personalization in diabetes therapy [6]. - The system's Meal Detection™ technology allows for better management of mealtime insulin delivery, accommodating missed or delayed doses [6]. Group 3: Benefits of the MiniMed™ 780G System - The MiniMed™ 780G system automates insulin delivery every five minutes, which helps maintain stable glucose control and reduces the burden of daily decision-making for users [4][9]. - The integration of the Instinct sensor with the MiniMed™ 780G system is expected to improve the daily management experience for individuals with type 2 diabetes [10].
Study showed MiniMed™ 780G system achieved ADA-recommended time-in-range goals even on days users forgot to bolus
Prnewswire· 2026-01-07 14:05
Core Insights - A new retrospective analysis published in Diabetes Care indicates that users of the MiniMed™ 780G system can achieve American Diabetes Association (ADA) recommended goals for time-in-range (TIR) even on days when mealtime boluses are missed, with a reported TIR of 76.3% on such days when using SmartGuard™ technology with optimal settings [1][4][6] Group 1: Study Findings - The study analyzed real-world CareLink™ user data from 369,467 individuals using the MiniMed™ 780G insulin pump, focusing on 54,553 users who experienced at least 10 days without bolusing between January 2, 2020, and March 31, 2025 [4] - Users employing recommended optimal settings achieved a TIR of 76.3%, compared to 69.3% for those using non-recommended settings, with a mean sensor glucose of 149 mg/dL versus 160 mg/dL [6] - More than 61% of users with recommended optimal settings met all three ADA recommended glycemic targets on missed bolus days, compared to 36.6% of users with other settings [6] Group 2: Implications for Diabetes Management - The findings underscore the advanced capabilities of the MiniMed™ 780G system, which adjusts insulin delivery every five minutes based on sensor readings, providing support when boluses are missed or carbohydrates are underestimated [3][4] - The study highlights the importance of optimized settings in diabetes management, particularly for users who may occasionally miss boluses, thereby reducing the overall burden of diabetes care [2][4] Group 3: Company Overview - Medtronic Diabetes aims to make diabetes management more predictable through advanced technology, including next-generation sensors and intelligent dosing systems [8] - The company has been a pioneer in diabetes technology for over 40 years, focusing on customer experience and innovative solutions to improve health outcomes [9]
Insulet (NasdaqGS:PODD) 2025 Earnings Call Presentation
2025-11-20 14:00
Introduction & Opening Remarks Clare Trachtman VP, Investor Relations Safe Harbor Statement This presentation contains forward-looking statements regarding, among other things, future operating and financial performance, product success and efficacy, the outcome of studies and trials, and the approval of products by regulatory bodies. These forward-looking statements are based on management's current beliefs, assumptions, and estimates and are not intended to be a guarantee of future events or performance. ...
FDA Clears MiniMed™ 780G System to Enable Integration with the Instinct Sensor, Made by Abbott, and Approves Use in Type 2 Diabetes
Prnewswire· 2025-09-02 12:45
Core Viewpoint - Medtronic has achieved significant FDA regulatory milestones for its MiniMed™ 780G system, expanding its use to adults with insulin-requiring type 2 diabetes and enabling integration with Abbott's Instinct sensor for type 1 diabetes management [1][4]. Group 1: Regulatory Milestones - The FDA has cleared the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), allowing integration with Abbott's Instinct sensor for type 1 diabetes [1]. - The MiniMed™ 780G system is now approved for use in adults aged 18 and older with insulin-requiring type 2 diabetes, making it the first automated insulin delivery (AID) system with Meal Detection™ technology for this demographic [4][5]. Group 2: Product Features and Benefits - The Instinct sensor, designed by Abbott, is noted as the world's smallest, thinnest, and most discreet integrated continuous glucose monitor (iCGM), with a wear time of up to 15 days [2]. - Clinical trials have shown that the MiniMed™ 780G system can lead to a 0.7% reduction in HbA1c and an increase in Time in Range from 72% to 81% [6]. Group 3: Future Plans and Customer Access - Medtronic and Abbott are finalizing compliance documentation for sensor integration, with ordering for the Instinct sensor expected to begin shortly [3]. - Existing customers will have priority access through the Innovations Program, and pre-orders for the Simplera Sync™ sensor will start later this month [3].
Tandem Diabetes Care(TNDM) - 2025 Q2 - Earnings Call Presentation
2025-08-06 20:30
Company Overview - Tandem Diabetes Care has approximately 480,000 in-warranty customers across 25 countries[5, 81] - The company employs around 2,600 individuals worldwide and is headquartered in San Diego[5, 81] - Tandem offers two pump platforms: t:slim X2 and Tandem Mobi, both featuring Control-IQ+ Technology and cleared for type 1 and type 2 diabetes, with multiple CGM sensor integrations[7, 83] Product Portfolio - The Tandem Mobi system is 55% smaller than other insulin pumps and offers on-body wear options[17, 18] - 95% satisfaction rate among Tandem Mobi Early Access Participants[16] - The t:slim X2 insulin pump is the first in the United States to integrate with three continuous glucose monitoring sensors[22] Market and Growth - Less than 40% of the approximately 2 million people with type 1 diabetes in the U S use an insulin pump[55] - Less than 20% of the approximately 3 million people with type 1 diabetes in the countries Tandem serves use a pump[55] - Approximately 5% of the greater than 2 million people living with type 2 Insulin Intensive Diabetes in the U S use an insulin pump[55] - The company estimates 2025 GAAP Sales guidance of $1 billion[58]
Insulet (PODD) - 2025 Q1 - Earnings Call Presentation
2025-05-08 20:44
Financial Performance & Growth - Insulet reported $2.1 billion in revenue for 2024[12] - The company achieved a gross margin of 69.8% in FY 2024, a year-over-year increase of 210 basis points[14] - Insulet's operating margin for FY 2024 was 14.9%, representing a 260 basis points increase year-over-year[14] - The company anticipates revenue growth between 19% and 22% for FY 2025[17] - International Omnipod revenue grew at a CAGR of approximately 17% from 2020 to 2025E, reaching ~$673 million[46] - U S Omnipod revenue grew at a CAGR of approximately 28% from 2020 to 2025E, reaching ~$1.8 billion[43] Omnipod 5 & Market Position - Omnipod is the 1 insulin pump for new pump users in the U S and EU in 2024[12] - Omnipod 5 is the first AID system FDA-cleared for both type 1 and type 2 diabetes in the U S [12] - Omnipod 5 demonstrated a 20%-23% increase in time in range for adults with type 1 and type 2 diabetes, respectively[19] - Approximately 365,000 customers are using Omnipod 5[12]
Tandem Diabetes Care(TNDM) - 2025 Q1 - Earnings Call Presentation
2025-04-30 20:52
Company Overview - Tandem Diabetes Care has approximately 480,000 in-warranty customers across 25 countries[5, 81] - The company is headquartered in San Diego with around 2,600 employees worldwide[5, 81] - Tandem offers two pump platforms: t:slim X2 and Tandem Mobi, both featuring Control-IQ+ Technology and cleared for type 1 and type 2 diabetes[8, 84] Product Portfolio - The Tandem Mobi system is 55% smaller than other insulin pumps[17] - 95% satisfaction rate among Tandem Mobi Early Access Participants[16] - The t:slim X2 insulin pump is the first in the US to integrate with three continuous glucose monitoring sensors[22] Market and Growth - Less than 40% of the approximately 2 million people with type 1 diabetes in the U S use an insulin pump[55] - Less than 20% of the approximately 3 million people with type 1 diabetes in the countries Tandem serves use a pump[55] - Approximately 5% of the over 2 million people with type 2 Insulin Intensive Diabetes in the U S use an insulin pump[55] Financials - Pumps are reimbursed at approximately $4,000 domestically and $3,000 OUS every 4 years[78] - Supplies cost approximately $4,000 per patient per year, with 120 cartridges and infusion sets used[78] - The total amount realized per patient is approximately $7,000-$8,000 in a four-year reimbursement cycle[79]
Sequel Med Tech and Senseonics Integrate Technologies to Create First Automated Insulin Delivery (AID) System with One-Year Continuous Glucose Monitor (CGM)
Globenewswire· 2025-04-29 11:30
Core Insights - Sequel Med Tech and Senseonics have announced a commercial development agreement to integrate the twiist Automated Insulin Delivery (AID) System with Senseonics' Eversense 365 CGM system, making it the first AID system compatible with a one-year CGM [2][3][5] - The integration aims to enhance diabetes management for individuals with type 1 diabetes by providing more tools for glucose control, convenience, and personalization [3][5] - The twiist AID System is designed to automatically adjust insulin delivery based on real-time sensor readings, offering flexibility in diabetes management [6][8] Company Overview - Sequel Med Tech is focused on developing innovative insulin delivery technologies and aims to simplify disease management through advanced systems [8] - Senseonics specializes in long-term implantable glucose monitoring systems, with the Eversense 365 being the only implantable CGM that offers continuous monitoring for up to one year [9][11] - The collaboration between Sequel and Senseonics represents a significant advancement in diabetes care, providing users with a comprehensive solution that combines advanced pump, algorithm, and sensor technologies [4][5] Product Details - The twiist AID System is FDA-cleared for individuals aged six and up with type 1 diabetes, allowing for precise insulin delivery tailored to individual needs [6] - Eversense 365 received FDA clearance as an integrated continuous glucose monitoring system, enabling its use within automated insulin delivery systems [5][10] - The integration of twiist and Eversense 365 is expected to be commercially available in Q3 2025, enhancing the options available for diabetes management [5][6]