Insulet Announces Full Market Release of Omnipod® 5 Automated Insulin Delivery System in Germany
28 Août 2023 - 12:00PM
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 the commercial launch of its
Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for
individuals aged two years and older with type 1 diabetes (T1D) in
its third market, Germany. Omnipod 5 is also available in the U.S.
and the U.K.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20230828947492/en/
“We know people in Germany living with type 1 diabetes want the
most advanced technology options for making diabetes management
easier,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice
President and Medical Director. “With our impressive data showing
improved clinical outcomes from users in the United States over the
past year, we are confident in our ability to make a difference in
Germany and additional markets in the near future.”
Omnipod 5 is the first CE marked tubeless automated insulin
delivery (also known as hybrid closed loop) system that integrates
with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. The
system1 includes the tubeless Pod enhanced with SmartAdjust™
technology and a handheld Controller integrated with the SmartBolus
Calculator. The system is interoperable with Dexcom G6 for
automated insulin delivery to help protect against high and low
glucose levels 2.
Laura Mysliwietz, a 29-year-old medical technologist, is beyond
excited that Omnipod 5 is now available in her country. “Before I
transitioned to Omnipod last year, I was using a traditional
insulin pump, but the tubing was always in my way. Now, I sometimes
forget that I have an insulin pump on my body,” said Laura. “Being
tubeless makes my life so much easier, and the addition of an
automated insulin delivery system will give me even more freedom to
manage my type 1 diabetes. I can’t wait to use Omnipod 5!”
Insulet has presented real-world data from 36,634 adults3 and
18,516 children and adolescents4 with type 1 diabetes in the U.S.
demonstrating that the highly favorable glycemic outcomes first
reported in Omnipod 5 pivotal trials are achievable among Omnipod 5
users of all ages in the real world.
Omnipod 5 is now available in Germany and has received its
medical aid numbers from the German National Association of
Statutory Health Insurance Funds (GKV-Spitzenverband), making it
reimbursable by health insurers.
People with type 1 diabetes should contact their healthcare
provider to get started with Omnipod 5. More information is also
available on the Omnipod website.
The Company’s goal is to make Omnipod 5 available for the
majority of Insulet’s European customers by the end of 2024.
1Integration with the Dexcom G6 CGM system is required for
automated insulin delivery.
2Study in 240 people with T1D aged 6 to 70 years involving two
weeks standard diabetes therapy followed by three months Omnipod 5
use in Automated Mode. Average time with high blood glucose in
adults/adolescents and children, standard therapy vs. three-month
Omnipod 5: 32.4% vs. 24.7%; 45.3% vs. 30.2%. Median time with low
blood glucose in adults/adolescents and children, standard therapy
vs. three-month Omnipod 5: 2.0% vs. 1.1%; 1.4% vs. 1.5%. Brown et.
al. Diabetes Care (2021). Study in 80 children with T1D aged 2 to
5.9 years involving two weeks of standard diabetes therapy followed
by three months Omnipod 5 use in Automated Mode. Average overnight
time (12AM-6AM) with high blood glucose in children for standard
therapy vs. Omnipod 5 was 38.4% vs. 16.9%. Average day time
(6AM-12AM) with high blood glucose in children for standard therapy
vs. Omnipod 5 was 39.4% vs. 29.5%. Median overnight time (12AM-6AM)
with low blood glucose in children for standard therapy vs. Omnipod
5 was 3.41% vs. 2.13%. Median day time (6AM-12AM) with low blood
glucose in children for standard therapy vs. Omnipod 5 was 3.43%
vs. 2.46%. Sherr J, et. al. Diabetes Care (2022).
3Lal R., et al, 57-OR Presented at the American Diabetes
Association Scientific Sessions 2023.
4Sherr J.L., et al, P-898 Presented at the American Diabetes
Association Scientific Sessions 2023.
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
tubeless 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, integrates with a continuous glucose monitor to
manage blood sugar with no multiple daily injections, zero
fingersticks, and can be controlled by a compatible smartphone or
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 in material
respects from those projected in these forward-looking statements.
Insulet undertakes no obligation to publicly update or revise any
forward-looking statements.
©2023 Insulet Corporation. Omnipod, Omnipod 5, and SmartAdjust
are trademarks or registered trademarks of Insulet Corporation in
the United States of America and various other jurisdictions. All
rights reserved. 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.
Source: Insulet Corporation
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230828947492/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
Insulet (NASDAQ:PODD)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Insulet (NASDAQ:PODD)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024