Insulet Announces Full Market Release of Omnipod® 5 Automated Insulin Delivery System in Germany

Rhea-AI Summary

Insulet Corporation launches Omnipod 5 Automated Insulin Delivery System in Germany, expanding its market presence. The system has shown improved clinical outcomes in the U.S., making it an attractive option for individuals with type 1 diabetes. Omnipod 5 is the first CE marked tubeless automated insulin delivery system that integrates with Dexcom G6 Continuous Glucose Monitoring System. The company aims to make Omnipod 5 available for the majority of its European customers by the end of 2024.

Positive

• Insulet expands market presence with the launch of Omnipod 5 in Germany
• Improved clinical outcomes demonstrated in the U.S.
• Integration with Dexcom G6 CGM system enhances functionality

Negative

• None.

ACTON, Mass.--(BUSINESS WIRE)-- 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 its third market, Germany. Omnipod 5 is also available in the U.S. and the U.K.

“We know people in Germany living with type 1 diabetes want the most advanced technology options for making diabetes management easier,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “With our impressive data showing improved clinical outcomes from users in the United States over the past year, we are confident in our ability to make a difference in Germany and additional markets in the near future.”

Omnipod 5 is the first CE marked tubeless automated insulin delivery (also known as hybrid closed loop) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. The system¹ includes the tubeless Pod enhanced with SmartAdjust™ technology and a handheld Controller integrated with the SmartBolus Calculator. The system is interoperable with Dexcom G6 for automated insulin delivery to help protect against high and low glucose levels ².

Laura Mysliwietz, a 29-year-old medical technologist, is beyond excited that Omnipod 5 is now available in her country. “Before I transitioned to Omnipod last year, I was using a traditional insulin pump, but the tubing was always in my way. Now, I sometimes forget that I have an insulin pump on my body,” said Laura. “Being tubeless makes my life so much easier, and the addition of an automated insulin delivery system will give me even more freedom to manage my type 1 diabetes. I can’t wait to use Omnipod 5!”

Insulet has presented real-world data from 36,634 adults³ and 18,516 children and adolescents⁴ with type 1 diabetes in the U.S. demonstrating that the highly favorable glycemic outcomes first reported in Omnipod 5 pivotal trials are achievable among Omnipod 5 users of all ages in the real world.

Omnipod 5 is now available in Germany and has received its medical aid numbers from the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), making it reimbursable by health insurers.

People with type 1 diabetes should contact their healthcare provider to get started with Omnipod 5. More information is also available on the Omnipod website.

The Company’s goal is to make Omnipod 5 available for the majority of Insulet’s European customers by the end of 2024.

¹Integration with the Dexcom G6 CGM system is required for automated insulin delivery.

²Study 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).

³Lal R., et al, 57-OR Presented at the American Diabetes Association Scientific Sessions 2023.

⁴Sherr J.L., et al, P-898 Presented at the American Diabetes Association Scientific Sessions 2023.

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 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.

Source: Insulet Corporation

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Investor Relations:



Deborah R. Gordon

Vice President, Investor Relations

(978) 600-7717

dgordon@insulet.com

Media:

Angela Geryak Wiczek

Senior Director, Corporate Communications

(978) 932-0611

awiczek@insulet.com

Source: Insulet Corporation