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MiniMed announces Health Canada License for Simplera Sync™ Sensor, Type 2 Diabetes Indication with MiniMed™ 780G System

Latest authorization expands MiniMed CGM portfolio in Canada

BRAMPTON, Ontario, April 28, 2026 (GLOBE NEWSWIRE)MiniMed Group, Inc. (MiniMed; Nasdaq: MMED), a global leader in insulin delivery, 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.**

MiniMed™ 780G

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 setΩ, reducing changes to once weekly and delivering 96% fewer injections than multiple daily injections.

MiniMed™ 780G System

“This license is a milestone for the diabetes community here in Canada,” said Chet Patel, Senior Business Director. “At MiniMed, our mission is to make every day a better day for people with diabetes. By continuing to evolve the MiniMed™ 780G system – including the addition of our Simplera Sync™ sensor and indication for adults 18 and older with Type 2 – we’re closer to that vision than ever before.”

The Simplera Sync™ sensor will be available in Canada later this year. Today, the MiniMed™ 780G system can be used with the Guardian™ 4 sensor.

About MiniMed 
MiniMed is a global leader in insulin delivery, constantly advancing therapies that support people with diabetes in more than 80 countries. Our full-stack, integrated ecosystem, including our insulin delivery systems, CGMs, algorithms, and easy-to-use app experience, is designed to work seamlessly together, supported by white-glove, wrap-around service. For over 40 years, we’ve pioneered therapies people can rely on by anticipating needs, reducing burden, and helping make life with diabetes easier. Our mission is to make every day a better day for people with diabetes.

MiniMed Contacts
Tanya Azuelos
Public Relations 
tanya@cleosocial.com

Ryan Weispfenning 
Investor Relations 
+1-763-505-4626 

*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.
Ω Data on file. As of April 15, 2025.

1. Choudhary P, et al. Diabetes Technol Ther 2024; 26 (Suppl. 3): S32-S37.

2. Matejko B, et al. Diabetes Care. 2022;45:2628–2635

CA-DBA-2600046

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/4a7a64b3-5dda-4bfa-a366-4f77b5b8fede

https://www.globenewswire.com/NewsRoom/AttachmentNg/92fd068b-fbeb-472f-aa45-24ec38fa5649

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