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Insulet Announces FDA Clearance of its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control

ACTON, Mass.–(BUSINESS WIRE)–Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubingless insulin pump technology with its Omnipod® brand of products, today announced that it has received Food and Drug Administration (FDA) for its Omnipod® 5 (Omnipod 5) automated insulin delivery system for people six years of age and older with type 1 diabetes. Omnipod 5 is the first Tubeless Automated Insulin Delivery (AID) that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against spikes and dips.

Omnipod 5 is designed to make glucose management easier than ever without multiple daily injections, tubes and finger pricks1 to help simplify life with diabetes.

“Omnipod 5 is a life-changing technology that we believe will revolutionize the marketplace and the lives of people with diabetes,” said Shacey Petrovic, President and CEO of Insulet. “We are incredibly proud of this sleek, easy-to-use system, designed to provide unparalleled freedom and to dramatically simplify insulin management and improve blood sugar control for our users.”

The Omnipod 5 System2 consists of the improved tubeless pod with SmartAdjust™ technology, the Dexcom G6 CGM and the Omnipod 5 mobile app with its integrated SmartBolus calculator. The user has the option of downloading this app to a compatible personal smartphone or using the Omnipod 5 controller, which comes free with the first prescription.

Every five minutes, SmartAdjust receives a Dexcom CGM value and trend, and predicts where the blood sugar will be in 60 minutes. The system then increases, decreases, or pauses insulin delivery using the user’s desired, personalized glucose target, helping to protect against spikes and dips.

“As a pioneer in integrated CGM, we are thrilled to see our years of collaboration with Insulet culminating in the first and only FDA cleared tubeless automated insulin delivery system,” said Kevin Sayer, President – CEO of Dexcom. “Omnipod 5 combines the precision and unparalleled user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize on-stand time.”

Omnipod 5 will launch through the pharmacy channel, providing customers with no-contract, no-commitment, no-obligation benefits. In the coming days, Insulet will bring Omnipod 5 in a limited version to market so that the company can incorporate learnings to deliver a top-notch product experience. Omnipod 5 is expected to be widely available soon after the limited market release.

Omnipod 5 was recently selected as CES® Winner of the 2022 Innovation Award in two categories: Health & Wellness and Wearables. The CES Innovation Awards are an annual competition recognizing outstanding design and engineering in consumer technology products.

People with diabetes can experience the benefits of Pod Therapy today with the OmnipodPromise™, which allows new and existing users to start with Omnipod DASH® and upgrade to Omnipod 5 at no additional cost when coverage is available.

To learn more, visit the Omnipod website.

Insulet will provide additional details on today’s announcement during the Company’s fourth quarter 2021 earnings conference call on February 23, 2022 at 4:30 p.m. EST. The link to the live call will be available here and will be archived for future replay. To participate in the live call by phone, please pre-register online here to receive a phone number, access code and unique registration ID required to participate in the call.

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 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, 2021 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.

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

2 Omnipod 5 Automated Insulin Delivery System consists of SmartAdjust™ Technology (licensed in K203774), Omnipod 5 Pod and Omnipod 5 App (licensed in K203768) and Omnipod 5 SmartBolus Calculator (licensed in K203772 ). Integration with the Dexcom G6 CGM is required for automated insulin delivery.

©2022 Island Corporation. Omnipod, Omnipod DASH, Omnipod 5, SmartAdjust and OmnipodPromise 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.