SAN DIEGO, May 19, 2015 /PRNewswire/-- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® Insulin Pump, today announced that it is now taking orders for the t:flex™ Insulin Pump, with shipments planned to begin in June. The 480-unit t:flex Pump, cleared by the U.S. Food and Drug Administration in January 2015, is the largest capacity insulin pump currently offered in the United States.
"Two-thirds of the healthcare providers we interviewed prior to developing the t:flex Pump cited limited capacity as the number one barrier to pump adoption for people with type 2 diabetes who use insulin," said Kim Blickenstaff, President and CEO of Tandem Diabetes Care. "We believe the t:flex Pump addresses an important unmet need in the diabetes community, with its 480-unit reservoir and 60-unit maximum bolus, and we are proud to offer this option for people with greater insulin needs."
The t:flex Pump is designed for people who require more than 80 units of U-100 insulin per day, such as teenagers with type 1 diabetes and many people with type 2 diabetes. For people with greater insulin needs, the pump offers the benefits of pump therapy without the frequent reservoir changes required by 200- and 300-unit pumps. It incorporates the same slim design, advanced Micro-Delivery® technology, and simple-to-use touch-screen interface as the t:slim Insulin Pump, rated #1 by pump users for two years in a row.1
People interested in the t:flex Insulin Pump can learn more and begin the order process at: www.tandemdiabetes.com/tflex
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects nearly 1 in 10 Americans. Approximately 25 million people have been diagnosed with diabetes in the United States, of which an estimated 3 million people require daily administration of rapid acting insulin and are candidates for pump therapy. Approximately 425,000 Americans with type 1 diabetes use an insulin pump, or roughly 27% of the type 1 diabetes population, and approximately 125,000 Americans with type 2 diabetes use an insulin pump, a small fraction of the type 2 diabetes population.
Published studies have shown that insulin pump therapy, when paired with proper training and support, can provide the following benefits compared to multiple daily injections:
- Better blood sugar control, especially in people with higher A1c levels2,3
- Continuous and more predictable insulin delivery4
- Delivers insulin in a more physiologic manner, decreasing length of time in hyperglycemia, with no increase in severe hypoglycemia2,4
About the t:flex Insulin Pump
The t:flex Pump is the first insulin pump designed for people who require more than 80 units of U-100 insulin per day. It is small and discreet, yet holds up to 480 units of insulin, providing up to 3 days of insulin delivery with fewer set and cartridge changes than standard 200- and 300-unit pumps. The t:flex Pump's color touch screen makes it easy to use – even for patients who are new to insulin pump therapy. The t:flex Pump also incorporates a built-in rechargeable battery and micro-USB port for convenient charging and fast data transfers to the t:connect® Diabetes Management Application, Tandem's state-of-the-art, Mac® and PC-compatible data management software.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with diabetes who use insulin. The Company manufactures and sells the t:slim® Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, and the t:flex™ Insulin Pump, the first pump designed for people with greater insulin requirements. Tandem is based in San Diego, California.
Forward Looking Statement
This press release includes forward-looking statements relating to the potential advantages of the t:flex Pump over existing insulin pumps, the anticipated commencement of shipments of the t:flex Pump and the potential benefits of insulin pump therapy compared to multiple daily injections. Statements related to the potential benefits of insulin pump therapy are based on published clinical studies, and presume that users of insulin pump therapy receive proper training and support, and that users operate the insulin pump in accordance with the accompanying user guide. Statements regarding the potential advantages of the t:flex Pump over existing insulin pumps and the anticipated commencement of shipments 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. The t:flex Pump is available for sale by or on the order of a physician.
t:connect, t:slim and Tandem Diabetes Care are registered trademarks, and t:flex is a trademark of Tandem Diabetes Care, Inc. Mac is a trademark of Apple Inc.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslim, #tflex, #tconnect, and $TNDM. Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/TandemDiabetes
1 dQ&A USA Diabetes Connections Surveys, 2013-2014. 2 Bode BW, Sabbah HT, Gross TM, Fredrickson LP, Davidson PC. Diabetes management in the new millennium using insulin pump therapy. Diabetes Metab Res Rev. arch 2015 9: 221-230. 3 Reznik Y, Cohen O, Aronson R, et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014; 384(9950):1265-1272. 4 Hoogma RPLM, Hammond PJ, Gomis R, et al. Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5-nations trial. Diabet Med. 2005;23:141-147.
SOURCE Tandem Diabetes Care, Inc.