ACTON, Mass.--(BUSINESS WIRE)--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 FDA clearance for use of Fiasp® (fast-acting insulin aspart) with the Omnipod® Insulin Management System and the Omnipod DASH™ Insulin Management System for adults. Fiasp is a new-generation, ultra fast-acting insulin developed by Novo Nordisk that enters the bloodstream two times faster than Novo Nordisk’s NovoLog®, so it more closely matches a body’s typical insulin response to a meal, thereby improving glycemic control. As a result, Fiasp is the first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.
Insulet completed extensive testing, with the support of Novo Nordisk, to demonstrate that Fiasp is safe and can be used with both the Omnipod System, as well as the Omnipod DASH Insulin Management System. Insulet is the first insulin pump in the United States to obtain this indication. The Omnipod Insulin Management System has been indicated for use with Fiasp in Europe since October 2018.
“Omnipod can now be used with the full spectrum of insulin, from generic to branded to ultra-fast-acting, and we are thrilled to deliver this additional flexibility for people to use their insulin of choice with the Omnipod System,” said Dr. Trang Ly, Senior Vice President, Medical Director. “Expanding our labeling to include Fiasp also opens the door for existing Fiasp users to seamlessly transition to an Omnipod System for their insulin delivery needs and further demonstrates our commitment to innovation.”
About the Omnipod DASH System:
Insulet’s Omnipod DASH System was designed to serve as the foundation for the Company’s future innovation. Designed with user discretion and convenience in mind, the Omnipod DASH System is a continuous insulin delivery system consisting of two simple components: a tubeless, waterproof*, Bluetooth® wireless technology Pod (pump) that holds up to 200 units of U-100 insulin** and a modern, color touch-screen Personal Diabetes Manager (PDM) that controls the Pod. The Omnipod DASH System has a suite of optional mobile apps for users, caregivers and HCPs to help simplify diabetes management. The Omnipod DASH System, which received FDA clearance in June 2018, is the only DTSec and ISO 27001 certified insulin pump for cyber and information security and safety.
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.
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 2019 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.
*The Pod has a waterproof IP28 rating for up to 25 feet for 60 minutes. The PDM is not waterproof.
**Additional insulins that are indicated for use with the Pod include: Novolog®, Humalog®, Admelog®, and Apidra®.
© 2019 Insulet Corporation. Omnipod and Omnipod DASH are trademarks or registered trademarks of Insulet Corporation. Fiasp and Novo Rapid are registered trademarks of Novo Nordisk and used with permission. 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. All rights reserved.