Insulet Announces CE Mark Approval of Omnipod® 5 Integration with Abbott FreeStyle Libre 2 Plus Sensor

Rhea-AI Summary

Insulet Corporation (NASDAQ: PODD) has received CE mark approval for the added compatibility of the Abbott FreeStyle Libre 2 Plus sensor with its Omnipod 5 Automated Insulin Delivery System. The system, the first and only tubeless hybrid closed loop system to achieve CE marking, is integrated with two CGM sensor brands, Abbott FreeStyle Libre and Dexcom. The Omnipod 5 integration is expected to be available in the United Kingdom and Netherlands in the first half of 2024, with additional markets to follow.

Insights

Medical Research Analyst

The CE mark approval for Insulet Corporation's Omnipod 5 to integrate with the Abbott FreeStyle Libre 2 Plus sensor signifies a substantial advancement in diabetes management technology. This integration is pivotal as it enhances the interoperability within the medical devices sector, particularly for continuous glucose monitoring systems. The Omnipod 5 system's unique selling proposition lies in its tubeless design and compatibility with multiple CGM sensors, which could potentially improve patient adherence due to ease of use and flexibility in sensor choice.

From a medical research perspective, this development could lead to broader clinical adoption and improved outcomes for individuals with type 1 diabetes. The SmartAdjust™ Technology that allows for predictive adjustments to insulin delivery could reduce the incidence of hypoglycemic events, a common concern in diabetes management. However, it is crucial to monitor post-market surveillance data to ensure that the anticipated benefits translate into real-world settings.

Market Research Analyst

Insulet's achievement in obtaining CE mark approval under the European Medical Device Regulation is a strategic milestone that could enhance its market position in Europe. The ability to integrate with multiple CGM brands like Abbott FreeStyle Libre and Dexcom offers a competitive edge, potentially increasing market share and customer loyalty. The phased launch strategy beginning in the United Kingdom and Netherlands reflects a targeted approach to market penetration, which could lead to a gradual increase in revenue streams.

However, the timeline for availability in the first half of 2024 suggests a need for investors to consider the long-term growth potential rather than immediate financial impact. It is essential to analyze how this integration aligns with the broader market trends of personalized healthcare and how it could influence the stock's performance in the context of the healthcare sector's regulatory and reimbursement landscape.

Financial Analyst

The announcement by Insulet Corporation is likely to be well-received by investors, given the potential for expanded market access and user base. The integration with Abbott's sensor is a significant differentiator in the insulin pump market. Financially, the news could lead to increased projections for future earnings as the company taps into the European market, which is substantial for diabetes care devices.

It is important to analyze the capital expenditure associated with the launch and the potential impact on the company's operating margin. Additionally, the response from competitors and the pace of technological advancements in diabetes care will be critical factors in assessing the long-term financial implications of this development.

• Omnipod 5 is the world’s first tubeless automated insulin delivery system to achieve CE mark approval with multiple continuous glucose monitoring (CGM) sensor brands.
• Latest Omnipod 5 integration is expected to be available in the United Kingdom and Netherlands in the first half of 2024, with additional markets to follow.

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 it has received CE mark approval under the European Medical Device Regulation for the added compatibility of the Abbott FreeStyle Libre 2 Plus sensor with Insulet’s Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with type 1 diabetes.

The Omnipod 5 Automated Insulin Delivery System with the Abbott FreeStyle Libre 2 Plus CGM sensor (Photo: Business Wire)

“The addition of the Abbott FreeStyle Libre 2 Plus sensor to our CGM compatibility expands accessibility of Omnipod 5, which has been a priority for Insulet since the system launched in 2022,” said Patrick Crannell, Senior Vice President and International General Manager of Insulet. “We are excited to have achieved this key milestone, which allows us to bring Omnipod 5 and choice of CGM to more people with diabetes.”

Omnipod 5 is the first and only tubeless hybrid closed loop system (also known as automated insulin delivery) that is approved for CE marking and integrated with two CGM sensor brands, Abbott FreeStyle Libre and Dexcom. The Omnipod 5 System consists of the tubeless Pod enhanced with SmartAdjust™ Technology and the Omnipod 5 Controller with its integrated Smartbolus Calculator.

The Pod’s SmartAdjust technology receives a CGM value and trend and predicts where glucose will be 60 minutes into the future. The System corrects every five minutes based on the user’s desired and customized glucose target.

Insulet expects Omnipod 5 integration with the Abbott FreeStyle Libre 2 Plus sensor to be available first in the United Kingdom and Netherlands in a phased launch in the first half of 2024, with additional markets to follow.

To learn more about Omnipod 5, visit the Omnipod website.

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’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system, integrated with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be fully controlled by a compatible personal smartphone or the 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 materially from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

©2024 Insulet Corporation. Omnipod and SmartAdjust are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved. The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission. Dexcom is a registered trademark of Dexcom, Inc. and used with permission. All other trademarks are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240207666366/en/

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

FAQ

What is the latest achievement of Insulet Corporation (PODD)?

Insulet Corporation has received CE mark approval for the added compatibility of the Abbott FreeStyle Libre 2 Plus sensor with its Omnipod 5 Automated Insulin Delivery System.

What is the Omnipod 5 System?

The Omnipod 5 System is the first and only tubeless hybrid closed loop system that is approved for CE marking and integrated with two CGM sensor brands, Abbott FreeStyle Libre and Dexcom.

When is the Omnipod 5 integration expected to be available in the United Kingdom and Netherlands?

The Omnipod 5 integration is expected to be available in the United Kingdom and Netherlands in the first half of 2024, with additional markets to follow.