Tandem Diabetes Care Receives Health Canada Approval to Market t:slim X2 Insulin Pump
October 12 2018 - 5:00PM
Business Wire
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
that it has received a Heath Canada Medical Device License for the
t:slim X2™ Insulin Pump. The t:slim X2 Pump features Dexcom G5®
Mobile CGM integration,1 making it the only CGM-integrated insulin
pump approved in Canada for making daily diabetes treatment
decisions without fingersticks.2 The Company plans to launch the
t:slim X2 Insulin Pump on a province-by-province basis throughout
the fourth quarter of 2018 pending the completion of pre-launch
activities, including product registration with provincial health
programs.
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)3. As the only
insulin pump integrated with Dexcom G5 Mobile CGM, dynamic glucose
data can be easily accessed and shared using a compatible mobile
device.4 The t:slim X2 Pump is up to 38% smaller than other insulin
pumps and holds up to 300 units of insulin.5
“People with diabetes in Canada have been asking for our
simple-to-use pump technology since the inception of Tandem and I
am thrilled that we are now able to offer a fresh, new choice in
insulin pump therapy,” said Kim Blickenstaff, President and CEO of
Tandem Diabetes Care. “This launch is especially important since
insulin pump options in Canada have become increasingly limited in
recent years, and this approval will allow us to bring the benefits
of our technology to more people with diabetes.”
For additional t:slim X2 Pump product and
safety information in Canada, or to begin the order process,
visit www.tandemdiabetes.ca.
Diabetes in Canada
According to Diabetes Canada (www.diabetes.ca), there are more
than 3.4 million Canadians living with diabetes, of which
approximately 10 percent have type 1 diabetes.6 Insulin pumps and
diabetes supplies 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. Tandem 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, which features integrated continuous
glucose monitoring. Tandem is based in San Diego, California.
Tandem Diabetes Care, t:slim X2, and t:simulator are trademarks,
registered trademarks, and/or the subject of a pending trademark
application in the US and other territories worldwide. 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 timing for the commercial launch of the t:slim X2 Pump
in Canada and our ability to complete pre-launch activities,
including product registration with provincial health programs in
Canada in 2018. These statements are subject to numerous risks and
uncertainties, including our ability to recruit, hire and train new
personnel to support our operations in Canada, manufacture
commercial quantities of a new version of the t:slim X2 Pump for
the Canadian market, our ability to launch a new system, which may
include entering into agreements with third parties for customer
ordering, training and logistics, and the risk that we may
encounter other challenges that may delay the commercial launch of
t:slim X2 Pump in Canada, 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 Dexcom G5 Mobile CGM System sold separately. The Dexcom G5
Mobile 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.2 If glucose alerts and
CGM readings do not match symptoms or expectations, use a blood
glucose meter to make diabetes treatment decisions. A fingerstick
is needed every 12 hours to calibrate.3 Tested to a depth of 3 feet
for 30 minutes.4 Following your shared data requires the Dexcom
Follow app.5 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.6 Estimated diabetes statistics in
Canada are generated by the Canadian Diabetes Cost Model; 2015.7
http://www.diabetes.ca/about-cda/public-policy-position-statements/access-to-diabetes-medication-supplies-medical-devices.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181012005460/en/
Tandem Diabetes CareMedia:Steve Sabicer+1
714-907-6264ssabicer@thesabicergroup.comorInvestors:Susan
Morrison+1 858-366-6900 x7005IR@tandemdiabetes.com
Tandem Diabetes Care (NASDAQ:TNDM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Tandem Diabetes Care (NASDAQ:TNDM)
Historical Stock Chart
From Sep 2023 to Sep 2024