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Insulet
Announces FDA Clearance of Omnipod GO™, a First-of-its-Kind Basal-Only Insulin Pod, Further Simplifying Life for People with
Type 2 Diabetes
2023-04-25
·
BioSpace
上市批准
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 the FDA clearance of its latest innovation, Omnipod GO™, an insulin delivery device cleared for use for people with
type 2 diabetes
age 18 or older who would typically take daily injections of long-acting
insulin
. This press release features multimedia. View the full release here: Omnipod GO™ (Photo: Business Wire) “Omnipod GO was designed to serve the more than three million people using basal insulin or transitioning to
insulin
therapy to treat their
type 2 diabetes
,” said Jim Hollingshead, President and Chief Executive Officer. “Our goal is to help people with
type 2 diabetes
successfully shift to
insulin
therapy with a product that fundamentally changes how they feel about
diabetes
management. We’re excited to bring this new solution to market and deliver on our mission to simplify life for people with
diabetes
.” Omnipod GO is a standalone, wearable, insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours. The newest addition to the Omnipod brand features a tubeless and waterproof* Pod which is offered in seven different pre-programmed daily rates, ranging from 10 to 40 units per day, and operates without the need for a handheld device to control the Pod. It has been cleared for use with the following
U-100 insulins
:
NovoLog
®,
Fiasp
®,
Humalog
®,
Admelog
®, and
Lyumjev
®. The product was developed to serve people with
type 2 diabetes
earlier in their treatment journey by starting them on Pod therapy for their
insulin
delivery, rather than daily injections. If a patient becomes insulin-intensive, meaning they require both basal and bolus
insulin
, the transition to another Omnipod product would be seamless.
Insulet
developed Omnipod GO with convenience in mind for both the primary care physician and the user, including prescribing, getting started, training and using the product. Customers may start Omnipod GO in their physician’s office and will be able to access ongoing supplies through their pharmacy benefit.
Insulet
plans to commercialize Omnipod GO in the United States in 2024. *The Pod has an IP28 rating for up to 25 feet for 60 minutes. 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. ©2023
Insulet Corporation
. Omnipod, Omnipod 5 and Omnipod GO are trademarks or registered trademarks of
Insulet Corporation
. 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: Contacts 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
Smart Multimedia Gallery Photo Omnipod GO™ (Photo: Business Wire) View this news release and multimedia online at:
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机构
Insulet Corp.
适应症
2型糖尿病
糖尿病
靶点
-
药物
Insulin (Ambrx)
Insulins(Halozyme)
门冬胰岛素
[+2]
标准版
¥
16800
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