Insulet to Present New Clinical Data for Preschool Children and Adults using the Omnipod® 5 System

Rhea-AI Summary

Insulet Corporation (NASDAQ: PODD) announced its schedule for the American Diabetes Association's 81st Scientific Sessions from June 25-29, 2021, where it will present new clinical outcomes data on the Omnipod 5 Automated Insulin Delivery System. This includes findings from the pivotal trial for preschool children and results following transitions from multiple daily injections for patients aged 6 to 70. A total of eight presentations are planned. The Omnipod 5 has received breakthrough device designation from the FDA and is expected to launch in limited release in the latter half of 2021.

Positive

• New clinical outcomes data for Omnipod 5 presented at ADA.
• Pivotal trial results show improvements in quality of life for patients using Omnipod 5.
• Omnipod 5 System expected for limited release in the second half of 2021.

Negative

• None.

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, today announced its schedule of events for the American Diabetes Association (ADA) Virtual 81^st Scientific Sessions June 25 – 29, 2021.

Following the release of its initial pivotal trial results in March, Insulet will present new clinical outcomes data for preschool children with type 1 diabetes using the Omnipod 5 Automated Insulin Delivery System (Omnipod 5), the first tubeless automated insulin delivery system with the option for full control by a user’s compatible smartphone to simplify life for people living with diabetes. The Company will also report additional results from the Omnipod 5 pivotal study in people aged 6 through 70 years living with type 1 diabetes, including clinical outcomes after transitioning from multiple daily injections, the Company’s three-month pivotal extension study results that includes six months of system use, and quality of life and satisfaction data.

In addition, Omnipod® System and Omnipod DASH^® System data and clinical outcomes for pediatric and adult patients with type 1 diabetes will be presented, for a total of eight oral and poster presentations at ADA.

The following is the schedule of Insulet clinical presentations:

Oral Presentations:

Saturday, June 26, 3:15 – 3:30 p.m.

70-OR Evaluation of the Omnipod 5 Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes (T1D) with Jennifer Sherr, Bruce W. Bode, Gregory P. Forlenza, Lori M. Laffel, Sue A. Brown, Bruce A. Buckingham, Amy B. Criego, Daniel Desalvo, Sarah A. MacLeish, David W. Hansen, Trang T. Ly, for the Omnipod 5 in Preschoolers Study Group

Saturday, June 26, 3:30 – 3:45 p.m.

71-OR Youth with Type 1 Diabetes and Their Parents Report Improved Quality of Life with the Omnipod 5 Automated Insulin Delivery System with Korey K. Hood, William H. Polonsky, Sarah A. MacLeish, Carol J. Levy, Lauren M. Huyett, Todd Vienneau, Trang T. Ly

Poster Presentations:

Poster 704-P Adults with Type 1 Diabetes Report Improved Quality of Life with the Omnipod 5 Automated Insulin Delivery System with Carol J. Levy, William Polonsky, Korey Hood, Sarah A. MacLeish, Lauren Huyett, Todd Vienneau, Trang T. Ly

Poster 709-P Improved Satisfaction and Perceived Usability with the Omnipod 5 Automated Insulin Delivery System Compared to Prior Therapy with Sarah A. MacLeish, William Polonsky, Korey Hood, Carol J. Levy, Lauren M. Huyett, Todd Vienneau, Trang T. Ly

Poster 716-P Transition from Multiple Daily Injections (MDI) to Omnipod 5 Automated Insulin Delivery System Improves A1c in Type 1 Diabetes (T1D) with Viral N. Shah, Amy B. Criego, Anders L. Carlson, Anuj Bhargava, Bruce W. Bode, Sue A. Brown, Greg P. Forlenza, Carol J. Levy, Sanjeev N. Mehta, Lori M. Laffel, Grazia Aleppo, Bruce A. Buckingham, Daniel J. DeSalvo, Irl B. Hirsch, Sarah A. MacLeish, Jordan E. Pinsker, Trang T. Ly

Poster 96-LB Glycemic Management over 6 Months with the Omnipod 5 Automated Insulin Delivery System with Anders L. Carlson, Amy B. Criego, Gregory P. Forlenza, Bruce W. Bode, Carol J. Levy, David W. Hansen, Irl B. Hirsch, Sue A. Brown, Richard M. Bergenstal, Jennifer L. Sherr, Sanjeev N. Mehta, Lori M. Laffel, Viral N. Shah, Anuj Bhargava, Ruth S. Weinstock, Sarah A. MacLeish, Daniel J. DeSalvo, Thomas C. Jones, Grazia Aleppo, Bruce A. Buckingham, Trang T. Ly, for the Omnipod 5 Research Group

Poster 702-P Glycemic Improvement in 5,094 Pediatric Patients with Type 1 Diabetes (T1D) Using the Omnipod Insulin Management System Over First 90 Days of Use with Daniel J. DeSalvo, Grazia Aleppo, Felipe Lauand, Lauren M. Huyett, Jay Jantz, Albert Chang, Todd Vienneau, Trang T. Ly

Poster 698-P Glycemic Improvement in 11,273 Adult with Type 1 Diabetes (T1D) Using the Omnipod Insulin Management System Over First 90 Days of Use with Grazia Aleppo, Daniel J. DeSalvo, Felipe Lauand, Lauren M. Huyett, Jay Jantz, Albert Chang, Todd Vienneau, Trang T. Ly

Promotional Activities:

Insulet has been selected by the American Diabetes Association to be featured throughout the event on ADA TV in the signature Thought Leadership Series, which highlights the work of five sponsors and broadcasts to a global audience of over 580,000 viewers during and after the meeting. There will be two featured Omnipod channels – one specific to Omnipod DASH and one specific to Omnipod 5 – and will feature Insulet executive leaders and several well-known endocrinologists.

Insulet’s virtual exhibit will feature Omnipod DASH and Omnipod 5 product information, highlighting how the tubeless insulin management system can simplify life for people with diabetes.

Visitors will also learn how Insulet can support clinicians prescribing Omnipod products to their patients, as well as the benefits of Insulet’s unique business model offering Omnipod products through the pharmacy channel, which requires no commitment or long-term contract and no charge for the Omnipod Personal Diabetes Manager, or PDM, with the first box of Pods. The booth will also offer information about the Company’s partnership with Glooko for automated access to patient data.

Next month, Insulet will host a webinar summarizing all of the Company’s data presented at ADA. This webinar will be led by Dr. Ly and will feature U.S. health care providers presenting the clinical data and sharing the features and benefits of Omnipod 5. To learn more and to register for the event, scheduled for July 22, click here.

The Omnipod 5 System received breakthrough device designation from the U.S. Food and Drug Administration and is currently under review. The Company expects to launch Omnipod 5 in limited release during the second half of 2021.

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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. 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: www.insulet.com and www.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, 2021 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.

©2021 Insulet Corporation. Omnipod, Omnipod 5, and Omnipod DASH are registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved.

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FAQ

What are the new clinical outcomes presented for PODD at the ADA conference?

Insulet will present data on the Omnipod 5 Automated Insulin Delivery System, focusing on its use among preschool children and adults transitioning from multiple daily injections.

When is the expected launch date for the Omnipod 5 System?

The Omnipod 5 is expected to launch in limited release during the second half of 2021.

What were the results of the pivotal trial for the Omnipod 5?

The pivotal trial results indicate improvements in quality of life and glycemic management for users transitioning from previous insulin delivery methods.

What is the significance of the breakthrough device designation for PODD's Omnipod 5?

The breakthrough device designation by the FDA expedites the development and review process for the Omnipod 5, aiming to enhance diabetes management.