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.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use
#tslimX2 and #TandemDiabetes. Follow Tandem Diabetes Care on
Facebook at facebook.com/TandemDiabetes. Follow Tandem Diabetes
Care on LinkedIn at linkedin.com/company/tandemdiabetes.
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.
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Media Contact: 858-255-6388 media@tandemdiabetes.com
Investor Contact: 858-366-6900 IR@tandemdiabetes.com
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