Market Overview

Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology


New Predictive Low Glucose Suspend Feature to Launch with Dexcom G6
CGM System Integration

Tandem Diabetes Care®, Inc. (NASDAQ:TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps available in the
United States, today announced U.S. Food and Drug Administration (FDA)
approval 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). This is
the first automated insulin delivery system approved for use by children
as young as 6 years old, and the first insulin pump designated as
compatible with integrated continuous glucose monitoring (iCGM) devices.
The Company plans to launch its new product with Dexcom G6® continuous
glucose monitoring (CGM) integration, which requires no fingersticks for
calibration or diabetes treatment decisions and was the first CGM device
to receive the iCGM designation from the FDA earlier this year.1,2,3
Tandem expects the t:slim X2 Pump with Basal-IQ technology to be
available in August 2018, and all in-warranty t:slim X2 users in the
United States will have the option to add the new feature free of charge
via remote software update.4

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. Use of the
t:slim X2 Pump with Basal-IQ technology in the pivotal clinical study
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.

"Hypoglycemia can be a significant source of fear for people who use
insulin and is a major cause of hospitalizations for people with
diabetes," said Dr. Greg Forlenza, Assistant Professor of Pediatrics at
the Barbara Davis Center, and one of the principal investigators in the
PROLOG (PLGS for Reduction
of Low Glucose)
trial. "Basal-IQ technology proved very effective in the clinical trial
at reducing time spent in hypoglycemia and improving time in range. The
system was also simple to learn and use, so the training burden was
minimal for the clinics and study participants compared to other
automated insulin delivery systems."

"The t:slim X2 Pump with Basal-IQ technology was designed to predict and
help prevent time spent low using best-in-class CGM technology," said
Kim Blickenstaff, president and CEO of Tandem Diabetes Care. "As the
first company to launch a touchscreen insulin pump capable of remote
feature updates, and now the first to have a pump approved with iCGM
compatibility, we are delivering new innovation to our customers at a
pace that is unprecedented in our industry, furthering our mission to
help improve the lives of people with diabetes."

Benefits of the New Basal-IQ Predictive Low
Glucose Suspend feature:

Predicts and helps prevent lows – Using CGM values, the Basal-IQ
feature looks ahead 30 minutes and suspends insulin when glucose is
predicted to drop below 80 mg/dL or if glucose is currently below 70
mg/dL and falling. The system resumes insulin once glucose values start
to rise.

No fingersticks – With Dexcom G6 CGM integration, the Basal-IQ
feature works with no fingersticks required for mealtime dosing or
calibration.1 Other benefits of the Dexcom G6 CGM include an
extended 10-day wear, acetaminophen blocking5, and the
ability to share real-time CGM data with up to 5 followers.6

Works silently in the background - No additional alerts or alarms
are required to use Basal-IQ technology compared to standard CGM-enabled
pumps. Users can choose whether or not to receive alerts when insulin is
suspended and resumed based on their personal preference.

No complicated modes to manage – The Basal-IQ feature has no
complicated settings to manage and operates without constant input or
interaction. The user only has to decide whether they want the feature
on or off.

Standard features of the t:slim X2 Insulin Pump:

Small and discreet – The t:slim X2 Pump is up to 38 percent
smaller than other pumps7, yet can hold up to 300-units of

Can be used with or without the Basal-IQ feature or CGM – When
advanced features are turned off, the t:slim X2 Pump removes the CGM
chart from the screen and puts the Bolus and Option buttons front and
center for easy access.

#1-rated customer support – Tandem's California-based customer
support has consistently ranked number one by pump users in independent
patient surveys since 2012.8

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

Free Demo App – Basal-IQ Technology Coming Soon

Tandem's free t:simulator™ App will be updated in early July to let you
experience the touchscreen interface of the t:slim X2 Pump with Basal-IQ
technology directly on your mobile device. For more information and to
download the app, visit

Free Software Update for Current t:slim X2 Pump Users

All in-warranty t:slim X2 Pump users in the United States have the
option to add the Basal-IQ feature free of charge via a software update
using a personal computer. The Basal-IQ feature update will require a
user to secure a new prescription from his or her healthcare provider
and complete a 45-minute online training module. Internet and computer
access are required for pump updates. Tandem expects the Basal-IQ
software update to be available for current t:slim X2 Pump users in
August 2018. Information about the requirements and update process is
available at

Basal-IQ Technology – Clinical Outcomes

In February 2018, the Company reported results from the six-week PROLOG
(PLGS for Reduction of Low Glucose) pivotal trial, a randomized
crossover study comparing two three-week periods of at-home insulin pump
use, one period using the t:slim X2 Pump with Basal-IQ technology, and
another period using a standard CGM-integrated t:slim X2 Pump without
automated insulin suspension. The study included 103 participants with
type 1 diabetes age 6 to 72 at four research centers across the United
States. Use of the system with Basal-IQ technology reduced the number of
sensor glucose readings below 70 mg/dL by 31 percent compared to the
control period using a standard CGM-integrated t:slim X2 Pump without
automated insulin suspension. Importantly, this marked reduction of time
spent in low glucose was accomplished without any increase in the rate
of hyperglycemia and participants overwhelmingly described the system as
simple to learn and use9.

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 more than three million people in the United
States require daily administration of insulin and are candidates for
pump therapy. More than 425,000 Americans with type 1 diabetes use an
insulin pump, or approximately 27 percent of the type 1 diabetes
population. In addition, approximately 125,000 Americans with type 2
diabetes use an insulin pump, a small fraction of the type 2 diabetes

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.

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 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, 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
1000mg of acetaminophen every 6 hours, use a blood glucose meter to make
diabetes treatment decisions.
2 Dexcom G6 CGM sold
3 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.
A new prescription and additional training are required for this
software update.
5 Dexcom G6 CGM readings can be used to
make diabetes treatment decisions when taking up to a maximum
acetaminophen dose of 1,000mg every 6 hours. Taking a higher dose may
affect the G6 readings.
6 Separate Follow App required.
38 percent smaller than MiniMed 630G and 670G and at least 28 percent
smaller than MiniMed 530G, Animas Vibe and Omnipod System. Data on file,
Tandem Diabetes Care.
8 dQ&A USA Diabetes Connections
Surveys, 2013-2017
9 Buckingham B, et al. PROLOG: A
Randomized Clinical Trial to Assess The Efficacy of Predictive Low
Glucose Suspend Versus Sensor-Augmented Pump Therapy in The Management
of Type 1 Diabetes [Session #026]. Vienna, Austria: 11th Annual Advanced
Technologies and Treatments for Diabetes Conference; 2018.

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