SAN DIEGO / Aug 03, 2023 / Business Wire / Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced a limited time offer for its Tandem Choice technology access program. This program provides new and renewing, eligible t:slim X2 Insulin Pump (t:slim X2) customers in the United States a pathway to ownership of the Tandem Mobi System (Tandem Mobi) for $199. The Tandem Mobi was recently cleared by the United States Food and Drug Administration to be used as a part of an automated insulin delivery system and a limited launch is expected to begin later this year with general availability in early 2024.

“Tandem Choice provides our customers time to decide which of our pump platforms best meets their needs and preferences, without having to delay experiencing the benefits of our Control-IQ technology,” said John Sheridan, president and chief executive officer. “Our #1 rated¹ t:slim X2, designed for people who want the convenience of an integrated touchscreen device, and our new Tandem Mobi, which offers smartphone control and new wearability options, provides people living with diabetes the power of choice in customizing an automated insulin delivery system to meet their individual needs.”

About the Tandem Choice Program:

The Tandem Choice Program will be offered for a limited time at a discounted price of $199 to customers who purchased or purchase a t:slim X2 between July 1, 2023 and December 31, 2023. Customers who purchased a t:slim X2 before July 1, 2023 and have 12 months or more remaining on their existing warranty are also eligible to participate in the Tandem Choice program for the originally offered price of $999. Customers do not need to take action or make an election to participate at this time. Eligible customers can choose to participate in the program any time before December 31, 2024. If customers choose to participate they will be able to make a one-time switch from their t:slim X2 to the Tandem Mobi. For additional terms and conditions please visit:
https://www.tandemdiabetes.com/support/benefit-programs/pump-switch

About the t:slim X2

With approximately 440,000 customers worldwide, t:slim X2 is the #1 rated insulin pump by users¹ and #1 in overall satisfaction by healthcare providers.² It’s designed for people who want the convenience of an integrated touchscreen device and the flexibility to choose the components of their insulin delivery system, such as a continuous glucose monitoring (CGM) sensor or from more than 30 mix-and-match infusion set options, to fit a wider range of needs and lifestyles. The t:slim X2 is up to 38 percent smaller than other manufacturers’ durable insulin pumps, and still holds up to 300 units of insulin. It also offers users modern technology, such as the ability to deliver bolus insulin through the convenience of a compatible smartphone.³

About the Tandem Mobi

Testing the limits of pump miniaturization, Tandem Mobi is the world’s smallest durable automated insulin delivery system.⁴ Less than half the size of the t:slim X2 pump, it offers control from an iOS mobile app⁵ and features an on-pump button that provides an alternative option to phone control for bolusing insulin. Tandem Mobi can fit in a coin pocket, be clipped to clothing, or worn on-body with an adhesive sleeve (sold separately). Its 200-unit insulin cartridge is compatible with all existing Tandem-branded infusion sets, including a new five-inch tubing option made just for Tandem Mobi. Infusion sets allow users to temporarily disconnect from their pump for convenience and provide the flexibility of more than 30 mix-and-match infusion site and tubing length combinations.

About Control-IQ Advanced Hybrid Closed-Loop Technology

Both the t:slim X2 and the Tandem Mobi will be offered with Control-IQ technology, a hybrid-closed loop algorithm for use by people with type 1 diabetes age 6 and up. Control-IQ technology uses compatible CGM sensor values to predict glucose levels 30 minutes ahead and adjust insulin delivery every 5 minutes to help prevent highs and lows, while still allowing the user to manually bolus for meals. It can also deliver automatic correction boluses (up to one an hour) to help prevent hyperglycemia.⁶ Real-world data shows immediate and sustained glycemic improvements — including more time in range and better sleep.⁷ Results from major studies of Control-IQ technology were published by the New England Journal of Medicine in October 2019, August 2020, and March 2023.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company based in San Diego, California, creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience. The company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology. For more information, visit tandemdiabetes.com.

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Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the anticipated timing for the limited launch and subsequent general commercial availability of the Tandem Mobi system. These forward-looking statements are subject to numerous risks and uncertainties, including risks associated with the commercial launch of a new product, as well as manufacturing risks and risks related to adequate reimbursement coverage. These and other risks are identified and described in greater detail under the “Risk Factors” heading of our most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events, or other factors.

¹ dQ&A US Diabetes Connections Patient Panel Report, Q1 2020-Q2 2023 (Jan 2020-Jun 2023).
² Seagrove Partners 2023 HCP Perspectives Report (N=265).
³ Bolus delivery from the t:connect mobile app requires a compatible smartphone model and operating system (sold separately). Only available to pump users who reside in the United States.
⁴ As of July 2023. Data on file, Tandem Diabetes Care.
⁵ The mobile app requires a compatible iPhone model and operating system (sold separately). Only available to pump users who reside in the United States. A complete list of compatible iPhones will be released closer to commercial availability.
⁶ If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus using the Personal Profile settings and a target of 110 mg/dL and delivers 60% of that value. An Automatic Correction Bolus will not occur within 60 minutes of a bolus that has been delivered or cancelled.
⁷Breton MD, Kovatchev BP. One-year real-world use of the Control-IQ advanced hybrid closed-loop technology. Diabetes Technol Ther. 2021;23(9):601-608. doi: 10.1089/dia.2021.0097.

Indications for Use

t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled (ACE) pump that is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in individuals six years of age and greater. The pump is intended for single patient use. The pump is indicated for use with U-100 insulin only.

Tandem Mobi insulin pump: The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals six years of age and greater.

Control-IQ technology: Control-IQ technology is intended for use with a compatible iCGM (sold separately) and ACE pump to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of type 1 diabetes mellitus in persons six years of age and greater. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with U-100 insulin only.

Responsible use of Control-IQ technology

Control-IQ technology does not prevent all highs and lows. Users must still bolus for meals and actively manage their diabetes. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

WARNING: Control-IQ technology should not be used by anyone under the age of six years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.

Control-IQ technology is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of a Tandem insulin pump and Control-IQ technology must: use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders. The Tandem pump, and the CGM transmitter and sensor must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

© 2023 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All third-party marks are the property of their respective owners.