공시 • Apr 30
Minimed Group, Inc. Announces Health Canada License for Simplera Sync Sensor, Type 2 Diabetes Indication with Minimed 780G System MiniMed Group, Inc. announced Health Canada has licensed new software for the MiniMed 780G system, marking a meaningful step forward in diabetes care for Canadians. With this authorization, the MiniMed 780G system now offers greater flexibility, combining Meal Detection technology, and SmartGuard, with both the Guardian 4 and Simplera Sync sensors. Additionally, the system is now compatible with Fiasp and indicated for adults 18 years and older with Type 2 diabetes. Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard, no overtape, and features a simple, two-step insertion process, introducing a more comfortable wear experience while reducing the daily burden of diabetes management. The MiniMed 780G system's adaptive algorithm automatically anticipates, adjusts, and corrects glucose levels every 5 minutes, 24/7 – working around the clock so users can focus on what matters. It's the only system featuring Meal Detection technology, which automatically detects rising glucose and adjusts insulin delivery to help keep levels in range – even when users occasionally miss a dose or underestimate carbs. The system uses a treat to target algorithm with flexible glucose targets as low as 5.5 mmol/L; combined with an adaptive approach, it more closely mimics glucose levels of someone not living with diabetes. Since its initial launch, the MiniMed 780G system has accumulated extensive clinical and real-world evidence across diverse populations around the world, demonstrating its ability to help many people with T1D enhance their glucose management, reaching over 80% time in range 1,2 when using optimal settings (active insulin time of two hours and 5.5 mmol/L target glucose), well above the international target of 70%. It is also the only system compatible with the world's first 7-day infusion set, reducing changes to once weekly and delivering 96% fewer injections than multiple daily injections. The Simplera Sync sensor will be available in Canada later this year. The MiniMed 780G system can be used with the Guardian 4 sensor. Fingersticks required in manual mode & to enter SmartGuard. If symptoms don't match alerts & readings, use a fingerstick. Refer to user guide. Pivotal trial participants spend avg of > 93% in SmartGuard. Data on file from CIP 321: Pivotal Trial (Age 14-75). N=152. 2020; 16 US sites. Participants in a clinical trial reported the sensor was smaller and lighter than other sensors they have used. Data on file: CIP330, N=243. TIR was reached using the optimal settings that are the combination of glucose target at 100 mg/dL (5.5 mmol/L) and Active Insulin Time (AIT) at 2 hours for at least 95% of the time. SmartGuard feature settings for each single patient must be defined by HCPs based on individual targets and specific needs. Refers to auto correct, which provides bolus assistance. As this is an automated bolus, no action is required, feature can be turned on and off. Meal Detection technology is a component of SmartGuard. Although Meal Detection Technology can help with missed bolus forgiveness, taking a bolus 15 – 20 minutes before a meal provides significant improvement in post-meal control. We recommend taking a meal bolus. Refers to SmartGuard feature. Individual results may vary. Some user interaction required. Data on file. As of April 15, 2025. Choudhary P, et al. Diabetes Technol Ther 2024; 26 (Suppl. 3): S32-S37. Matejko B, et al. Diabetes Care. 2022;45:2628–2635. Breakeven Date Change • Apr 22
Forecast breakeven date pushed back to 2027 The 11 analysts covering MiniMed Group previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 54% to 2026. The company is expected to make a profit of US$162.4m in 2027. Average annual earnings growth of 68% is required to achieve expected profit on schedule. Breakeven Date Change • Apr 20
Forecast to breakeven in 2026 The 11 analysts covering MiniMed Group expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$50.6m in 2026. Earnings growth of 62% is required to achieve expected profit on schedule. 공시 • Apr 14
MiniMed Group, Inc. to Report Q4, 2026 Results on Jun 03, 2026 MiniMed Group, Inc. announced that they will report Q4, 2026 results at 3:45 AM, Pacific Standard Time on Jun 03, 2026 공시 • Mar 18
MiniMed Announces Fda Clearance Of MiniMed Flex, The Company’s Smallest Insulin Pump Featuring Its First Smartphone-Controlled Design MiniMed announced U.S. Food and Drug Administration clearance of MiniMed Flex, a next-generation discreet, smartphone-controlled insulin pump designed to fit seamlessly into everyday life. MiniMed Flex represents a major redesign of MiniMed's insulin pumps. About half the size of the MiniMed 780G pump and roughly the size of two stacked insulin vials, MiniMed Flex is the company's first screenless design created in partnership with people living with diabetes to deliver an intuitive, lifestyle-friendly way to manage the condition. MiniMed Flex is powered by the company's most advanced SmartGuard algorithm with Meal Detection technology, which has proven clinical performance that exceeds worldwide Time in Range recommendations. At commercial launch, MiniMed Flex will support the company's newest sensor portfolio, including Simplera Sync sensor and the Instinct sensor, made by Abbott. MiniMed Flex represents a major redesign of MiniMed's insulin pumps. Key features include: Small, sleek design with high insulin capacity: Designed to be worn wherever users prefer — in a pocket or out of sight — while delivering a 300-unit insulin reservoir to support a range of insulin needs. Smartphone-controlled: Managed through a compatible mobile app, eliminating the traditional pump screen, with seamless software updates delivered through iOS and Android devices at launch. Sensor compatibility: At commercial launch, MiniMed Flex will support the company's newest sensor portfolio, including Simplera Sync sensor and the Instinct sensor, made by Abbott. Extended infusion set options: Works with MiniMed's infusion set portfolio, including the Extended infusion set with up to 7 days of wear, delivering up to 96% fewer injections compared with traditional insulin therapy. Proven AID performance: Real-world results have demonstrated 80% Time in Range with recommended settings. MiniMed also announced the MiniMed Forward Program, which allows customers who start on the MiniMed 780G system to upgrade to the MiniMed Flex system for $0. New MiniMed 780G system users who enroll in the program will be notified when the MiniMed Flex system becomes commercially available in the U.S. and will receive instructions for completing the upgrade. The launch of the MiniMed Flex system will begin with a customer experience phase this spring involving select current MiniMed customers, followed by a broader commercial launch planned for the summer. MiniMed Flex is cleared for individuals ages 7 and older with type 1 diabetes, and for individuals 18 years and older with insulin-requiring type 2 diabetes. The MiniMed Flex system is MiniMed's next-generation automated insulin delivery system featuring a small, smartphone-controlled insulin pump powered by the proven SmartGuard algorithm with Meal Detection technology. The system includes a 7-day infusion set, a 300-unit reservoir, and is designed with a compact form factor for users to wear as they like — in a pocket or out of sight. Eligible users of the MiniMed 780G system may upgrade to MiniMed Flex through the MiniMed Forward Program. Because MiniMed Flex maintains compatibility with MiniMed's existing reservoir and infusion set portfolio, the transition is designed to be straightforward for current users. At commercial launch, MiniMed Flex will support the company's newest sensor portfolio, including Simplera Sync sensor and the Instinct sensor, made by Abbott. 공시 • Mar 11
Minimed Group, Inc. Announces Ce Mark for Minimed 780G System with Instinct Sensor Made by Abbott MiniMed Group, Inc. announced CE (Conformité Européenne) Mark for use of the MiniMed 780G system with the Instinct sensor, made by Abbott. This milestone further expands sensor choice for users of its most advanced automated insulin delivery system. MiniMed 780G system is already compatible with the Guardian 4 and Simplera Sync sensors, which both offer up to seven days of wear. The Instinct sensor, designed exclusively by Abbott for MiniMed automated insulin delivery (AID) is the world's smallest, thinnest, most discreet CGM and offers a wear time of up to 15 days. MiniMed 780G system users can now choose between a 7-day or 15-day sensor depending on what best fits their needs. MiniMed anticipates the commercial launch of the MiniMed 780G system with Instinct sensor in the first European countries during the summer. The company will be presenting the full system at the 19th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2026) taking place in Barcelona from March 11-14, 2026. In Europe the MiniMed 780G system is indicated for use by individuals aged 2 years and older with insulin-requiring diabetes (type 1 and type 2), whose total daily dose of insulin is 6 units per day or more. The system is also CE Marked in Europe for use during pregnancy. In the U.S., the MiniMed 780G system is indicated for use by individuals with type 1 diabetes aged 7 years and older, and for insulin-requiring type 2 diabetes aged 18 years and older with clinical trials underway to examine the use of the MiniMed 780G system in 2–6-year-olds. The MiniMed 780G system has not been approved for use in pregnancy by the FDA. CE Mark approval of the MiniMed Go Smart MDI system with the Instinct Go sensor, made by Abbott, is also confirmed, with availability in select countries in Europe expected in the summer. It's the company's most advanced automated insulin delivery system that automatically adjusts insulin every five minutes based on real-time glucose readings, helping reduce highs and lows and making diabetes management easier and less time-consuming. The Instinct sensor, made by Abbott, offers up to 15 days of wear, and is worn discreetly. It's the world's smallest and thinnest integrated CGM. 
