MiniMed's Smallest App-Controlled Insulin Pump is Now Available in the U.S.

For years, people who use insulin pumps have had to think about where and how they wear their device each day. While diabetes technology has advanced, many still had to choose between clinical performance and a pump that works with their lifestyle. Few products have offered both.

Designed to let diabetes take a backseat, the MiniMed Flex™ system gives people the freedom to live on their own terms without sacrificing the clinical performance they depend on. About half the size** of other MiniMed pumps, it's the company's most compact pump while still holding 300 units of insulin. It is engineered to fit into everyday life no matter what a person wants to wear.

"For too long, people managing diabetes have had to choose between effective therapy and the freedom to just live their lives. MiniMed Flex™ changes that," said Que Dallara, chief executive officer of MiniMed. "It's small enough to disappear, smart enough to handle the hard work, and now it's in people's hands. This is the MiniMed we're becoming — faster, and more focused than ever on delivering on our Mission. Better days start now."

The MiniMed Flex™ system is powered by MiniMed's most advanced SmartGuard™ algorithm — the only system with Meal Detection™ technology that detects rapid rises in sensor glucose and delivers a correction dose for occasional missed meal boluses or underestimated carb counts.^§ Working seamlessly in the background, the system continuously adjusts and autocorrects insulin delivery up to every 5 minutes^‡ based on real-time glucose readings from the Simplera Sync™ sensor, helping users spend more time in their target range with less daily effort. Real-world results have demonstrated 80% Time in Range (TIR)¹ with recommended settings — exceeding worldwide TIR recommendations.^◊ Compatible with MiniMed's Extended™ infusion set, users can also benefit from up to seven days of wear and up to 96% fewer injections compared to traditional insulin therapy. ^Δ

"Having worked with people using MiniMed Flex™, I've seen firsthand how app control can simplify everyday diabetes management," said Anders Carlson, MD, executive director, International Diabetes Center, and director, HealthPartners diabetes program; assistant professor, University of Minnesota Medical School. "For many patients, two devices are central to daily life: their automated insulin delivery system and their phone. Bringing those experiences together, while continuing to leverage the trusted MiniMed algorithm, represents a meaningful evolution in how diabetes technology can support people throughout the day."

The MiniMed Flex™ system is FDA cleared for people with type 1 diabetes ages 7 years and older, as well as adults ages 18 years and older with insulin-requiring type 2 diabetes.

Reimbursement support and access programs are available through MiniMed's customer support team. For more information and to order MiniMed Flex™ visit minimed.com/en-us/products/minimed-flex-system.

About MiniMed
MiniMed is a global leader in insulin delivery, constantly advancing therapies that support people with diabetes in 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.

Any forward-looking statements are subject to risks and uncertainties such as those described in MiniMed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

1. Arrieta A, et al. Diabetes Obes Metab. 2022;10.1111/dom.14714 .

*MiniMed Flex™ system with Instinct sensor is investigational. Not cleared by the FDA for any use and not commercially available in the U.S.

**Compared to MiniMed™ 780G pump

§Taking a bolus 15 – 20 minutes before a meal helps to keep blood sugar levels under control after eating.

‡Refers to SmartGuard^TM feature. Individual results may vary.

◊Due to inherent real-world study limitations, caution is advised when attempting to extrapolate these results to new patients. There could be significant differences.

ΔAssumes 4 injections per day for 30 days and one infusion set change every seven days.

SOURCE MiniMed