Tandem Diabetes Care receives FDA clearance to market t:flex Insulin Pump

Jan 12 2015

Tandem Diabetes Care^®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim^® Insulin Pump, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:flex™ Insulin Pump. At 480 units, the insulin reservoir of the t:flex Pump has the largest capacity currently available in the United States.

"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 Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care. "This first expansion of our product portfolio reflects our ongoing commitment to deliver user-friendly products that address unmet needs in the diabetes community."

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 the United States in the second quarter of 2015. People interested in more information about the t:flex Pump can visit the Company website at www.tandemdiabetes.com/tflex. The Company will report its fourth quarter and year-end 2014 financial results later in the first quarter, and anticipates providing guidance for 2015, including initial commercialization objectives for the t:flex Pump, at that time.

Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects more than 29 million people in the United States, or nearly 1 in 10 Americans. Tandem estimates that 3 million people in the United States require daily administration of insulin and are candidates for pump therapy. More than 400,000 Americans with type 1 diabetes use an insulin pump, or approximately 27% of the type 1 diabetes population. In addition, approximately 75,000 Americans with type 2 diabetes use an insulin pump, a small fraction of the type 2 diabetes population.

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.

SOURCE Tandem Diabetes Care, Inc.