Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, today announced the commercial launch of its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D) in the United Kingdom (UK).

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Omnipod® 5 Automated Insulin Delivery System (Photo: Business Wire)

“Since its commercial launch in the United States, Omnipod 5 has had a remarkable impact on people with diabetes,” said Jim Hollingshead, Insulet President and CEO. “Every day, we hear how this revolutionary experience of Omnipod 5 reduces the burden and improves quality of life for people with diabetes, and we are excited to make a difference in other parts of the world, beginning with the UK. We are committed to making Omnipod 5 an option for as many people as possible, as quickly as we can, and working hard to secure broad access globally.”

The Omnipod 5 System is where simplicity meets advanced technology. Omnipod 5 is the first CE marked tubeless hybrid closed loop system (also known as automated insulin delivery) that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System to automatically adjust insulin delivery and help protect against high and low glucose levels¹. The system² consists of the tubeless Pod enhanced with SmartAdjust™ technology and the Omnipod 5 Controller with its integrated SmartBolus Calculator. The system is interoperable with the Dexcom G6 CGM for automated insulin delivery.

Every five minutes, SmartAdjust technology receives a CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target. Omnipod 5 simplifies daily diabetes management by making many of these dosing decisions for the user, while they focus on other aspects of their life.

Lydia Parkhurst, a 26-year-old geography teacher who enjoys backpacking and has travelled the world with her Omnipod DASH^® System, has been a Podder since 2015. “I am so excited for the release of Omnipod 5 in the UK,” said Lydia. “I can’t wait to experience the freedom of being tubeless while also having the support of hybrid closed loop technology. The combination will make living with type 1 diabetes far less complicated – allowing me to live my life to the fullest!”

“With NICE³ set to approve hybrid closed loop in England and Wales later this year, we are delighted that more hybrid closed loop systems such as Omnipod 5 are becoming available to help people manage their type 1 diabetes,” said Karen Addington, CEO at JDRF UK. “Diabetes management is very personal, so access to a range of technology options is crucial. A wider choice of hybrid closed loop systems offers people with type 1 diabetes evidence-based treatment they can trust to support them to manage their condition with confidence.”

Insulet is working in partnership with the National Health Service (NHS) at all levels to ensure access to Omnipod 5 for people with type 1 diabetes.

Insulet plans to release Omnipod 5 in Germany in the fall of 2023.

To learn more about Omnipod 5, visit the Omnipod website.

¹Study in 240 people with T1D aged 6 to 70 years involving two weeks standard diabetes therapy followed by three months Omnipod 5 use in Automated Mode. Average time with high blood glucose in adults/adolescents and children, standard therapy vs. three-month Omnipod 5: 32.4% vs. 24.7%; 45.3% vs. 30.2%. Median time with low blood glucose in adults/adolescents and children, standard therapy vs. three-month Omnipod 5: 2.0% vs. 1.1%; 1.4% vs. 1.5%. Brown et. al. Diabetes Care (2021). Study in 80 children with T1D aged 2 to 5.9 years involving two weeks of standard diabetes therapy followed by three months Omnipod 5 use in Automated Mode. Average overnight time (12AM-6AM) with high blood glucose in children for standard therapy vs. Omnipod 5 was 38.4% vs. 16.9%. Average day time (6AM-12AM) with high blood glucose in children for standard therapy vs. Omnipod 5 was 39.4% vs. 29.5%. Median overnight time (12AM-6AM) with low blood glucose in children for standard therapy vs. Omnipod 5 was 3.41% vs. 2.13%. Median day time (6AM-12AM) with low blood glucose in children for standard therapy vs. Omnipod 5 was 3.43% vs. 2.46%. Sherr J, et. al. Diabetes Care (2022).

²Integration with the Dexcom G6 CGM is required for automated insulin delivery.

³National Institute of Health and Care Excellence.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible smartphone or Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit: insulet.com and omnipod.com.

Forward-Looking Statement:

This press release may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 24, 2023 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

©2023 Insulet Corporation. Omnipod, Omnipod DASH, Omnipod 5, and SmartAdjust are trademarks or registered trademarks of Insulet Corporation in the United States of America and various other jurisdictions. All rights reserved. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.

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