Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System, today announced that it plans to pause the pivotal study of the Omnipod Horizon™ Automated Glucose Control System to correct a software anomaly. The identified anomaly could result in the system using an incorrect glucose value which has the potential to impact insulin delivery. The issue is rare, but because of the potential to affect insulin delivery, the Company will pause the study until the anomaly is corrected. No adverse events have been reported due to this issue.
“Patient safety is our number one priority,” said Dr. Trang Ly MBBS FRACP PhD, Senior Vice President, Medical Director. “While we are disappointed to pause the trial, we are proud of how we were able to proactively and swiftly diagnose the issue and come to this decision. The experience highlights the benefits of our significant investment in mobile and cloud technology, which enable our engineers to monitor enormous amounts of information in real-time from the Omnipod Horizon clinical trials. This information allowed us to quickly identify, investigate, and decide to correct the issue. The enthusiasm from our trial participants has been overwhelmingly positive and we are excited for what Omnipod Horizon will offer our customers.”
The Company expects the updated software will be available by the end of April 2020. The study pause will modestly impact the timing of bringing Horizon to market, which is now anticipated to happen in early 2021.
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 other therapeutic areas. For more information, please visit: www.insulet.com and www.omnipod.com.
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 in February 2020 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.
© 2020 Insulet Corporation. Omnipod and Horizon are trademarks or registered trademarks of Insulet Corporation. All rights reserved.