[February 20, 2018] |
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Tandem Diabetes Care Applies for Health Canada Medical Device License
Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps, today announced its
submission of a medical device license application to Health Canada to
market its t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous
glucose monitoring (CGM) integration1. The Company plans to
launch the pump in Canada in the second half of 2018, subject to
regulatory approvals.
"This application is another important step toward achieving our
strategic goal of bringing the benefits of the t:slim X2 Insulin Pump to
people outside of the United States," said Kim Blickenstaff, President
and CEO of Tandem Diabetes Care. "When available, the t:slim X2 will
provide people in Canada a competitive choice in the durable insulin
pump market, which we believe will be of particular interest as the only
pump with Dexcom G5 Mobile CGM integration."
The Company anticipates that the t:slim X2 Insulin Pump offered in
Canada will be capable of displaying both English and French, offer a
24-hour clock, and will display glucose readings in millimoles per liter
(mmol/L).
Canadian residents interested in signing up for email updates on
Tandem's plans in Canada can visit www.tandemdiabetes.com/canada.
About the t:slim X2 Insulin Pump
The simple-to-use t:slim X2 Insulin Pump includes advanced features like
a large color touchscreen, Bluetooth® radio, rechargeable battery, USB
connectivity and watertight construction (IPX7)2. It is the
only pump that integrates with Dexcom G5® Mobile CGM, the first
CGM-enabled pump approved in the United States 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
Diabetes in Canada
According to Diabetes Canada (www.diabetes.ca),
there are more than 3.4 million people with diabetes in the country.5
By 2020, diabetes is expected to account for more than 3.5% of total
public health care spending, accounting for CAN$16.9 billion in annual
health care costs.6 Insulin pumps and diabetes supples are a
covered benefit for qualifying recipients of disability tax credit,
assistive devices programs, and qualifying expenses for registered
disability savings plans offered in various forms across Canadian
provinces.7
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 (News - Alert) @tandemdiabetes; use #tslimX2,
#tsliminthewild and $TNDM. Follow Tandem Diabetes Care on Facebook
at www.facebook.com/TandemDiabetes. Follow
Tandem Diabetes Care on LinkedIn (News - Alert) 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 G5 is a registered trademark 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 timing of review of a Canadian health
care medical device license application, the anticipated launch of a
Tandem product in Canada in the second half of 2018 and the expected
features of Tandem's future products. These statements are subject to
numerous risks and uncertainties, including the risk that Health Canada
will approve the Company's license when expected, or at all, the
Company's ability to establish 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 in Canada, as well as other
risks identified in the Company's most recent Annual Report on Form 10-K
and Quarterly Reports on Form 10-Q, respectively, 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. 5 Estimated diabetes
statistics in Canada are generated by the Canadian Diabetes Cost Model;
2015 6 An Economic Tsunami: the Cost of Diabetes in
Canada, Canadian Diabetes Association, December 2009 7 http://www.diabetes.ca/about-cda/public-policy-position-statements/access-to-diabetes-medication-supplies-medical-devices
View source version on businesswire.com: http://www.businesswire.com/news/home/20180220006513/en/
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