SAN DIEGO--(BUSINESS WIRE)--Apr. 30, 2018--
Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps, today announced
receipt of CE mark approval for the t:slim X2™ Insulin Pump with Dexcom
G5® Mobile continuous glucose monitoring (CGM) integration1.
The Company plans to begin commercial sales of the pump in select
international markets beginning in the second half of 2018. The Company
has been commercializing its touchscreen insulin pumps in the United
States since 2012, and received U.S. Food and Drug Administration (FDA)
approval of the t:slim X2™ Insulin Pump with Dexcom G5 Mobile CGM
integration in August 2017.
The simple-to-use t:slim X2 Insulin Pump includes advanced features like
a large color touchscreen, rechargeable battery, USB connectivity and
watertight construction (IPX7)2. It is the only pump that
integrates with Dexcom G5 Mobile CGM, and the first CGM-enabled pump
approved to let users make treatment decisions without pricking their
finger.3 The t:slim X2 Pump is up to 38% smaller than other
insulin pumps and holds up to 300 units of insulin.4
“As our first product to receive CE mark, this milestone is key to the
fulfillment of our vision to bring the features and benefits of our
unique insulin pump technology to people outside of the United States,”
said Kim Blickenstaff, President and CEO of Tandem Diabetes Care. “Our
plans to launch the t:slim X2 Pump internationally in the second half of
this year is of particular strategic importance during this time where
insulin pump options are becoming increasingly limited."
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com)
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 is based in San Diego, California.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2,
#tsliminthewild 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.
Tandem Diabetes Care and t:slim X2 are either registered trademarks or
trademarks of Tandem Diabetes Care, Inc. in the United States and/or
other countries. Dexcom and Dexcom G5 are registered trademarks of
Dexcom, Inc.
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, 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 launch of a Tandem
product in international markets in the second half of 2018 and demand
for the Company’s products outside the United States. These statements
are subject to numerous risks and uncertainties, including the risk that
the Company’s ability to establish distributor relationships and/or the
commercial and logistical infrastructure to support the planned launch
of Tandem products outside the United States on a timely basis and
without unanticipated expenses, the Company’s ability to develop,
manufacture, supply and support Tandem products in conformance with
applicable laws outside the United States, market acceptance of the
Company’s existing products and products under development by physicians
and people with diabetes, the potential that newer products that compete
with the Company’s products, or other technological breakthroughs for
the monitoring, treatment or prevention of diabetes, may render the
Company’s products obsolete or less desirable, as well as other risks
identified in the Company’s most recent Annual Report on Form 10-K,
Quarterly Report 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. The Company 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 Dexcom G5 Mobile CGM sold separately.
2
Tested to a depth of 3 feet for 30 minutes
3 CGM-based
treatment requires fingersticks for calibration; may result in
hypoglycemia if calibration not performed, when taking acetaminophen, or
if symptoms/expectations do not match CGM readings.
4
38% smaller than MiniMed 630G and 670G and at least 28% smaller than
MiniMed 530G, Animas Vibe and Omnipod System. Data on file, Tandem
Diabetes Care.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180430005319/en/
Source: Tandem Diabetes Care, Inc.
Tandem Diabetes Care
Media:
Steve Sabicer, 714-907-6264
ssabicer@thesabicergroup.com
or
Investors:
Susan
Morrison, 858-366-6900 x7005
IR@tandemdiabetes.com
