SAN DIEGO--(BUSINESS WIRE)--
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 that it is now accepting orders for its
next-generation t:slim X2™ Insulin Pump. The t:slim X2 Pump boasts an
advanced Bluetooth radio and is optimized for use with Tandem's recently
approved Tandem Device Updater, used to update software and add new
features from a personal computer as they are approved by the Food and
Drug Administration (FDA).1 Shipments of the t:slim X2 Pump
are expected to begin late October 2016.
"We are making rapid product development advancements, and the t:slim X2
Insulin Pump is the first and only available insulin pump that can be
remotely updated to provide customers access to future features and
technologies outside of the typical insurance pump replacement cycle,"
said Kim Blickenstaff, president and Chief Executive Officer of Tandem
Diabetes Care. "Integration with the Dexcom G5® Mobile continuous
glucose monitoring system, and a predictive low glucose suspend (PLGS)
algorithm, are among the first features we plan to release as remote
software updates on the t:slim X2 platform."
The t:slim X2 Pump is the newest addition to the Company's family of
innovative insulin pumps. All Tandem pumps feature a high-contrast color
touchscreen with a streamlined, user-friendly interface. This provides
people rapid access to frequently used features, while making these
features simple to learn and simple to use.2 Each Tandem
product utilizes modern technology, such as a built-in rechargeable
battery and micro-USB port for convenient charging and fast data
transfers.
Additional features of the t:slim X2 Pump include:
-
Up to 38% smaller than other insulin pumps3,4
-
300-unit capacity
-
Rechargeable battery, which saves hundreds of dollars in out of pocket
costs4
-
Durable aluminum housing
-
Watertight (IPX7) construction, tested to a depth of three feet for 30
minutes
-
Advanced Bluetooth radio, capable of communicating with compatible
devices and future technologies
-
Optimized for use with the Tandem Device Updater for remote software
and feature updates from a personal computer1
The t:slim X2 Pump will replace Tandem's first-generation t:slim®
Insulin Pump. The Company will continue to support current t:slim Pumps,
in addition to the t:slim G4™ and t:flex® Insulin Pumps.
The t:slim X2 Pump is intended for the subcutaneous delivery of insulin,
at set and variable rates, for the management of diabetes mellitus in
persons requiring insulin, for individuals 12 years of age and greater.
An application for use in younger populations is currently under review
by the FDA.
For additional product and safety information, or to begin the order
process, visit www.tandemdiabetes.com/tslimX2
or call (877) 801-6901, Monday - Friday between 6am and 5pm Pacific Time
About the Tandem Device Updater
The Tandem Device Updater, cleared by the FDA in July 2016, is a tool
for the remote update of Tandem insulin pump software from a personal
computer. The first use of the Tandem Device Updater is to provide
t:slim® Insulin Pumps purchased before April 2015 with a free update to
the latest software features. This updated software began shipping on
new t:slim Pumps as of April 2015 and includes a variety of product
enhancements for convenience and flexibility. Future software
improvements and enhancements for Tandem pumps will be implemented
through the Tandem Device Updater as they are approved for commercial
distribution.
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 3 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% 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 population.
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 X2™ Insulin Pump, the slimmest and
smallest durable insulin pump currently on the market, the t:flex®
Insulin Pump, the first pump designed for people with greater insulin
requirements, and the t:slim G4™ Insulin Pump, the first continuous
glucose monitoring-enabled pump with touch-screen simplicity. Tandem is
based in San Diego, California.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2,
#tslimG4, #tflex, #tconnect, and $TNDM.
Follow Tandem Diabetes Care
on Facebook at www.facebook.com/TandemDiabetes.
Follow
Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.
t:slim, t:flex, and Tandem Diabetes Care are registered trademarks, and
t:slim X2 and t:slim G4 are trademarks of Tandem Diabetes Care, Inc.
Dexcom and Dexcom G5 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 commencement of shipments
of the t:slim X2 Insulin Pump in late October 2016; the Company's plans
to complete the development and obtain regulatory approval of future
features to release on the t:slim X2 platform as remote software
updates, including integration with the Dexcom G5 Mobile CGM system and
a PLGS algorithm; and the Company's plans to utilize the Tandem Device
Updater to update software and add new features to the t:slim X2 pump
from a personal computer as they are approved by the FDA. These
statements are subject to numerous risks and uncertainties, including
the Company's ability to commence commercial scale manufacturing of the
t:slim X2 pump on a timely basis, the Company's reliance on third-party
suppliers the Company's ability to source various product components in
sufficient quantities that meet the Company's quality requirements, the
Company's ability to complete the development of integration of the
Dexcom G5 Mobile CGM and the PLGS algorithm with the t:slim X2 pump, the
Company's ability to utilize the Tandem Device Updater as intended, the
Company's ability to obtain regulatory approvals for future products and
product features generally, as well as other risks identified in
Tandem's most recent Annual Report on Form 10-K and Quarterly Report on
Form 10-Q, and other documents that Tandem files with the Securities and
Exchange Commission. Investors 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 Subject to FDA approval. Charges may apply.
2
Schaeffer N, Parks L, Verhoff E, et al. J Diabetes Sci Technol.
March 2015.9:221-230.
3 38% smaller than MiniMed 630G
and 670G and 25% smaller than MiniMed 530G, Animas Vibe and Omnipod
System.
4 Data on file. Tandem Diabetes Care, Inc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161004005554/en/
Tandem Diabetes Care, Inc.
Media Contact:
Steve
Sabicer, 714-907-6264
ssabicer@thesabicergroup.com
or
Investor
Contact:
Susan Morrison, 858-366-6900 x7005
smorrison@tandemdiabetes.com
Source: Tandem Diabetes Care
News Provided by Acquire Media
