Market Overview

Tandem Diabetes Care Announces Commercial Launch of t:slim X2 Insulin Pump with Basal-IQ Technology in the United States


Tandem Diabetes Care®, Inc. (NASDAQ:TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps with continuous
glucose monitoring (CGM) integration, today announced its launch of the
t:slim X2™ Insulin Pump with Basal-IQ™ Technology, a predictive low
glucose suspend (PLGS) feature designed to help reduce the frequency and
duration of low glucose events (hypoglycemia). It is integrated with the
Dexcom G6® CGM System, which requires no fingersticks for calibration or
diabetes treatment decisions.1,2 The Company has begun
sending emails with update instructions to all in-warranty t:slim X2
users in the United States, who have the option to add the new feature
free of charge via remote software update.3 t:slim X2 Pumps
pre-loaded with Basal-IQ Technology are expected to begin shipping to
new customers by the end of August.

Tandem's Basal-IQ algorithm is designed to look 30 minutes into the
future to predict where glucose levels are heading. The device suspends
insulin delivery when low glucose is predicted, then automatically
resumes insulin delivery once glucose levels begin to rise. In the
pivotal clinical study, use of the t:slim X2 Pump with Basal-IQ
Technology demonstrated a 31 percent relative reduction in time spent
below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled
insulin pump without the feature. The system received high usability
scores in the study, with 93 percent of participants indicating that the
system was easy to use, and 97 percent indicating that they felt
confident using the system.4

"This launch marks the achievement of our goal to offer people with
diabetes a simple-to-use automated insulin delivery feature that can
reduce time spent low without adding significant burden to the pump
therapy experience," said Kim Blickenstaff, president and CEO of Tandem
Diabetes Care. "Our ability to provide remote software updates, allowing
in-warranty t:slim X2 Pump users the ability to add Basal-IQ Technology
to their current pumps using a personal computer, is unparalleled in the
industry and further differentiates the t:slim X2 Insulin Pump from
other devices on the market."

Update Instructions for In-warranty t:slim X2 Pump Users

No action is required at this time. Individual emails are being sent to
all in-warranty t:slim X2 Pump users in the United States with
information on how to start the update process. Emails are being sent
out in batches, with all users anticipated to have received the
information by the end of August. The Basal-IQ feature update will
require a new prescription and completion of a 45-minute online training
module, all of which will be coordinated through a simple-to-use online
portal. Internet and computer access are required for pump updates.
Basal-IQ Technology is only compatible with the Dexcom G6® CGM System.
t:slim X2 Pump users who have Dexcom G5® Mobile CGM supplies they plan
to use may want to postpone this update until they are ready to switch
to the new Dexcom G6 CGM System. More information about the update
process and system requirements is available at

Free Basal-IQ Technology Demo App

Tandem's free t:simulator™ App lets users experience the touchscreen
interface of the t:slim X2 Insulin Pump with Basal-IQ Technology
directly on a mobile device. For more information and to download the
app, visit

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (
is a medical device company dedicated to improving the lives of people
with diabetes through relentless innovation and revolutionary customer
experience. The Company takes an innovative, user-centric approach to
the design, development and commercialization of products for people
with diabetes who use insulin. Tandem manufactures and sells the t:slim
X2™ Insulin Pump with Basal-IQ™ technology. The t:slim X2 Pump is
capable of remote feature updates using a personal computer and is the
only automated insulin delivery device approved for children as young as
6 years old. Tandem is based in San Diego, California.

For additional product and safety information, or to begin the order
process, visit
or call 877-801-6901, Monday – Friday between 6am and 5pm Pacific Time.

Important Safety Information

RX ONLY. The t:slim X2 Insulin Pump with Basal-IQ Technology (the
System) consists of the t:slim X2 Insulin Pump, which contains Basal-IQ
Technology, and a compatible CGM. CGM sold separately. The t:slim X2
Insulin 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 t:slim X2 Insulin Pump can be used solely
for continuous insulin delivery and as part of the System. When the
System is used with a compatible iCGM, the Basal-IQ Technology can be
used to suspend insulin delivery based on CGM sensor readings.
Interpretation of the System results should be based on the trends and
patterns seen with several sequential readings over time. CGM also aids
in the detection of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments. Compatible
iCGM systems are intended for single patient use and require a
prescription. The System is indicated for use in individuals 6 years of
age and greater. The System is intended for single patient use and
requires a prescription. The System is indicated for use with NovoLog or
Humalog U-100 insulin. The System is not approved for use in pregnant
women, persons on dialysis, or critically ill patients.

Tandem Diabetes Care is a registered trademark, and t:slim X2, Basal-IQ
and t:simulator are trademarks of Tandem Diabetes Care, Inc. Dexcom and
Dexcom G6 are registered trademarks of Dexcom, Inc. All other trademarks
are the property of their respective owners.

Forward-Looking Statement

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, that
concern matters that involve risks and uncertainties that could cause
actual results to differ materially from those anticipated or projected
in the forward-looking statements. These forward-looking statements
relate to, among other things, the anticipated timing for the commercial
launch of the t:slim X2 with Basal-IQ Technology and our ability to
offer the Basal-IQ software update for current t:slim X2 Pump users.
These statements are subject to numerous risks and uncertainties,
including our ability to commence commercial scale manufacturing of the
t:slim X2 with Basal-IQ Technology, our ability to launch a new system
to facilitate online training and prescription handling for existing
t:slim X2 customers upgrading their existing devices, and the risk that
we may encounter other challenges that may delay the commercial launch
of t:slim X2 with Basal-IQ Technology, as well as other risks identified
in our most recent Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q, and other documents that we file with the Securities and
Exchange Commission. Readers 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 or review any
forward-looking statement in this press release because of new
information, future events or other factors.

1 If glucose alerts and CGM readings do not match symptoms or
expectations or if taking over the recommended maximum dosage amount of
1000 mg of acetaminophen every 6 hours, use a blood glucose meter to
make diabetes treatment decisions.
2 Dexcom G6 CGM sold
separately. The Dexcom G6 CGM transmitter can only be paired with one
medical device (either a Dexcom receiver or t:slim X2 Pump) and one
consumer device (phone or tablet) at the same time.
3 A
new prescription and additional training are required for this software
4 Forlenza GP, Li Z, Buckingham BA, Pinsker JE,
et al. Predictive low glucose suspend reduces hypoglycemia in adults,
adolescents, and children with type 1 diabetes in an at-home randomized
crossover study: Results of the PROLOG trial [published online August 8,
2018]. Diabetes Care. doi:10.2337/dc18-0771.

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