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$80 million

Endocrinology Medical Device

Feb9Tandem Diabetes Care Announces Pricing of $60 Million Underwritten Public Offering of Common Stock »

Mar23Tandem Diabetes Care Announces Pricing of Underwritten Public Offering of Common Stock »

Nov29Tandem Diabetes Care to Draw Down $35 Million under Existing Term Loan Facility with CRG »

Jan12Tandem Diabetes Care Amends Term Loan Facility with CRG »

Sep9Tandem Diabetes Care Announces FDA Approval of t:slim G4 Insulin Pump with CGM Integration »

Jul30Tandem Diabetes Care Announces Development Agreement with Dexcom for Integration of Future Generation CGM Systems »

May19Tandem Diabetes Care Launches t:flex™ Insulin Pump »

Mar4Tandem Diabetes Care Announces Closing of Underwritten Public Offering of Common Stock »

Jan12
Tandem Diabetes Care Announces FDA Clearance of the t:flex™ Insulin Pump »

SAN DIEGO, January 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(2). 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.

 

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.

Apr9Tandem Diabetes Care and Capital Royalty Amend and Restate Term Loan Facility »

Nov13Tandem Diabetes Care Prices Initial Public Offering »

Jan23Tandem Diabetes Care and Capital Royalty Close Term Loan Facility »