Insulet Presents Positive Clinical Trial Results for the Omnipod® Horizon™ Hybrid Closed-Loop System at the American Diabetes Association's 78th Scientific Sessions

Jun 24, 2018

Insulet Presents Positive Clinical Trial Results for the Omnipod® Horizon™ Hybrid Closed-Loop System at the American Diabetes Association's 78th Scientific Sessions

Omnipod®HorizonSystem Significantly Improves Glycemic Control in Patients with Type 1 Diabetes

BILLERICA, Mass.--(BUSINESS WIRE)--Jun. 24, 2018-- Insulet Corporation (NASDAQ:PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that positive results from the most recent clinical trial of the Omnipod® Horizon Automated Glucose Control System (Omnipod Horizon System) were presented during the American Diabetes Association (ADA) 78th Scientific Sessions in Orlando. The study demonstrated that the Omnipod Horizon System performed well and was safe for over five days of use in adults, adolescents, and children with type 1 diabetes.1-3

The study was conducted in a supervised hotel setting under free-living conditions with unrestricted meals and moderate-intensity exercise and included patients who use multiple daily injections or traditional tubed insulin pumps as their standard therapy. Study participants spent significantly less time in hypoglycemia, more time in the target glucose range and had better overnight glycemic control compared to their standard therapy. The investigational device includes features that allowed study participants to customize their diabetes management by adjusting their target blood glucose levels and insulin delivery.

“We recognize that everyone’s treatment needs are different, and the Omnipod Horizon System provides individualized diabetes management to address real world challenges,” said Dr. Jennifer L. Sherr, MD, PhD, of Yale University School of Medicine. “One of the important features is the ability for users to tailor the system for exercise and high fat meals to maintain good glycemic control.”

During the study, glucose control was maintained in the target range (70 to 180 mg/dL) between 69% and 79% of the time overall, and between 74% and 85% of the time during the overnight period, across all age groups. Hypoglycemia was very low overnight, ranging from 0.7% and 1.3% of the time, across age groups.

“In the era of personalized medicine, Insulet is committed to bringing our innovative technology to the global diabetes community and our clinical data give us confidence that the Omnipod Horizon System will be a significant advancement in diabetes management,” said Dr. Trang Ly, Senior Vice President and Medical Director. “We are very pleased that for the second consecutive year, Omnipod Horizon System research was highlighted in the official ADA Press Program based upon its overall excellence in furthering research and advancing treatment for people with diabetes.”

About Insulet Corporation:

Insulet Corporation (NASDAQ:PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to making the lives of people with diabetes and other conditions easier through the use of 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 multiple therapeutic areas. Founded in 2000, more than 140,000 users across the globe rely on Insulet’s Omnipod Insulin Management System to bring simplicity and freedom to their lives. For more information, please visit: www.insulet.com, www.myomnipod.comand www.omnipodeurope.com.*

*Starting July 1, 2018, Insulet will assume direct distribution of its Omnipod Insulin Management System in Europe, including sales, marketing, training and customer support activities. This will allow Insulet to be closer to the diabetes community and identify opportunities to support European customer needs over the long-term, as it already does in the United States and Canada.

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 22, 2018 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.

© 2018 Insulet Corporation. Horizon, Omnipod and the Omnipod logo are trademarks or registered trademarks of Insulet Corporation. All rights reserved.

1Buckingham BA, Sherr JL, Forlenza GP, Peyser TA, Lee JB, O’Connor JB, Dumais B, Huyett LM, Layne JE, Ly TT. Safety and Performance of the Omnipod®Hybrid Closed-Loop System in Adults with Type 1 Diabetes Over Five Days Under Free-Living Conditions. Presented at the ADA 78th Scientific Sessions, June 22-26, 2018.

2Forlenza GP, Buckingham BA, Sherr JL, Peyser TA, Lee JB, O’Connor JB, Dumais B, Huyett LM, Layne JE, Trang T. Ly TT. Safety and Performance of the Omnipod®Hybrid Closed-Loop in Adolescents with Type 1 Diabetes Over Five Days Under Free-Living Conditions. To be presented at the ADA 78th Scientific Sessions, June 22-26, 2018.

3Sherr JL, Forlenza GP, Buckingham BA, Peyser TA, Lee JB, O’Connor JB, Dumais B, Huyett LM, Layne JE, Ly TT. Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Children Ages 6-12 Years Over Five Days Under Free-Living Conditions. To be presented at the ADA 78th Scientific Sessions 78th Scientific Sessions, June 22-26, 2018.

Source: Insulet Corporation

Investor Relations and Corporate Communications:
Deborah R. Gordon, 978-600-7717
Vice President, Investor Relations and Corporate Communications
dgordon@insulet.com
or
Media:
Natalie MacMillan, 978-600-7421
Marketing Manager, Global Public Relations & Field Programs
nmacmillan@insulet.com