Tandem Diabetes Care Announces FDA Clearance of the t:flex™ Insulin Pump
"In recognizing that one size does not fit all, the t:flex Pump was developed using Tandem's proprietary technology platform to bring t:slim's benefits to people with greater insulin needs," said
People with diabetes require different amounts of insulin based on their level of insulin sensitivity, which can vary significantly from person to person. The t:flex Pump is designed for people who require more than 100 units of U-100 insulin per day, such as teenagers with type 1 diabetes and many people with type 2 diabetes. The pump offers people with greater insulin needs the benefits of pump therapy without the frequent reservoir changes required by 200- and 300-unit capacity pumps. It incorporates the same slim design, advanced Micro-Delivery™ technology, and simple-to-use, touch-screen interface as the t:slim Insulin Pump, which is rated #1 by pump users.
The t:flex Pump is expected to launch in
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects more than 29 million people in
Recent studies suggest that insulin pump therapy reduces average blood glucose levels and overall insulin needs in people with type 2 diabetes compared with standard therapy using multiple daily injections. In Tandem's market research, two-thirds of endocrinologists cited limited capacity as the number one barrier to insulin pump adoption for people with type 2 diabetes who are insulin dependent.
Forward Looking Statement
This press release includes forward-looking statements relating to the anticipated timing of the commercial launch of the t:flex Pump and the potential advantages of the t:flex Pump over existing insulin pumps. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including: Tandem's ability to begin commercial scale manufacturing of the t:flex Pump and associated cartridges; the potential that newer products that compete with the t:flex Pump, or other technological breakthroughs for the monitoring, treatment or prevention of diabetes, may render the t:flex Pump obsolete or less desirable; and other risks identified in Tandem's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update any forward-looking statement in this press release.
The t:flex Insulin Pump is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.
 dQ&A Patient Panel, Q2 2014
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