Home Therapeutic relationship Insulet Announces CE Mark Approval for Omnipod® 5 Automated Insulin Delivery System

Insulet Announces CE Mark Approval for Omnipod® 5 Automated Insulin Delivery System


ACTON, Mass.–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the world leader in tubingless insulin pump technology with its Omnipod® brand of products, today announced that it has received CE Marking under the European Medical Device Regulation for its Omnipod 5 (Omnipod 5) Automated Insulin Delivery System for people aged two years and older with type 1 diabetes.

“The global diabetes community is seeing tremendous excitement about Omnipod 5, and we’re thrilled to have reached this final milestone,” said Jim Hollingshead, President and CEO of Insulet. “With Omnipod 5, customers can experience the lifestyle benefits of tubeless, wearable innovation and achieve positive clinical outcomes while managing their diabetes.”

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 and help protect against high and low glucose levels. 1. The system2 consists of the improved tubeless Pod with SmartAdjustMT technology, the Omnipod 5 controller with its integrated SmartBolus calculator and the Dexcom G6 CGM.

Every five minutes, SmartAdjust technology receives a CGM value and trend, and predicts where blood sugar will be in 60 minutes. The system then increases, decreases, or pauses insulin delivery based on the user’s desired, personalized glucose goal.

“Today’s announcement is a significant step forward for people living with diabetes in Europe,” said Kevin Sayer, President and CEO of Dexcom. “We are proud to partner with Insulet, combining our industry-leading Dexcom G6 CGM technology with their tubeless, portable insulin delivery system, to improve clinical outcomes and reduce the burden of blood sugar management for patients. people with diabetes.

New clinical data demonstrating the safety and efficacy of Omnipod 5 in people with newly diagnosed type 1 diabetes will be presented at the upcoming European Association for the Study of Diabetes (EASD) meeting in Stockholm , in Sweden, on Thursday, September 22. To learn more and to register for EASD, visit the conference website.

Insulet expects Omnipod 5 to be available in select countries from mid-2023. To learn more about Omnipod 5, visit the Omnipod website.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to making life easier for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System offers a unique alternative to traditional insulin delivery methods. With its simple, portable design, the disposable pod provides up to three days of uninterrupted insulin delivery without the need to see or handle a needle. Insulet’s latest innovation, the Omnipod 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system integrated with a continuous blood glucose monitor to manage blood sugar without multiple daily injections and without finger pricks.3. Insulet is also leveraging its unique Pod design by adapting its Omnipod technology platform for non-insulin subcutaneous drug delivery in other therapeutic areas. For more information, please visit: insulet.com and omnipod.com.

Forward-looking statement:

This press release may contain forward-looking statements regarding Insulet’s expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs regarding future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those anticipated by it. 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 differ materially from those expressed or implied by such 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, 2022 in the section entitled “Risk Factors”, and in its other filings of 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 differ materially from those projected in such forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

1Study in 240 people with T1D aged 6-70 including 2 weeks of standard diabetes treatment followed by 3 months of using Omnipod 5 in automated mode. Average duration of hyperglycaemia in adults/adolescents and children, standard therapy vs Omnipod 5 over 3 months: 32.4% vs 24.7%; 45.3% versus 30.2%. Median time to hypoglycemia in adults/adolescents and children, standard therapy vs Omnipod 5 over 3 months: 2.0% vs 1.1%; 1.4% versus 1.5%. Brown et al. Diabetes Care (2021). Study in 80 children with T1D aged 2-5.9 years including two weeks of standard diabetes treatment followed by three months of Omnipod 5 use in automated mode. The average length of night (12:00 a.m. to 6:00 a.m.) with high blood glucose in children for standard therapy versus Omnipod 5 was 38.4% versus 16.9%. The average length of day (6h to 12h) with high blood glucose in children for standard therapy versus Omnipod 5 was 39.4% versus 29.5%. The median length of night (12:00 a.m. to 6:00 a.m.) with low blood sugar in children for standard therapy versus Omnipod 5 was 3.41% versus 2.13%. The median length of day (6h to 12h) with low blood glucose in children for standard therapy versus Omnipod 5 was 3.43% versus 2.46%. Sherr J, et al. Diabetes Care (2022).

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

3If a user’s glucose alerts and G6 readings do not match symptoms or expectations or if a user supports the maximum recommended dose of 1000 mg of acetaminophen every six hours, it is appropriate to use a blood glucose meter to make diabetes treatment decisions.

©2022 Island Corporation. Omnipod, Omnipod 5 and SmartAdjust are trademarks or registered trademarks of Insulet Corporation in the United States of America and other jurisdictions. All rights reserved. Dexcom G6 is a registered trademark of Dexcom and used with permission. All other trademarks are the property of their respective owners. Use of third-party marks does not constitute an endorsement or imply a relationship or other affiliation.