ABBOTT PARK, Ill. and SAN
DIEGO, Oct. 15, 2019
/PRNewswire/ -- Abbott (NYSE: ABT) and Tandem Diabetes Care
(NASDAQ: TNDM) announced today that they intend to develop and
commercialize integrated diabetes solutions that combine Abbott's
world-leading1 glucose sensing technology with Tandem's
innovative insulin delivery systems to provide more options for
people to manage their diabetes.
"To help customers fully realize the potential of the latest
advancements in diabetes technology, we're ensuring our products
have interoperability, creating a cohesive ecosystem where people
with diabetes can manage their condition across devices from us and
other companies seamlessly," said Jared
Watkin, senior vice president, Diabetes Care, Abbott. "By
bringing together Abbott's and Tandem's leadership and expertise,
we can provide new ways for people to manage their diabetes that
are impactful and can integrate easily into their daily lives,
especially people who rely on insulin pumps."
The need for interoperability between diabetes devices is widely
recognized in the industry. Tandem's t:slim X2™ insulin pump was
the first to receive U.S. Food and Drug Administration (FDA)
clearance in a new device category called alternate controller
enabled (ACE) infusion pumps earlier this year. The special
controls for ACE pumps allow for reliable and secure communication
with compatible external devices like Abbott's next generation
FreeStyle Libre system, which would give people with diabetes the
ability to select tools and tailor their diabetes management to
best meet their needs. Abbott and Tandem are currently in
discussions regarding a final agreement for the technical
implementation of device integration and associated commercial
support activities.
"The FDA's new interoperable designations for the various
components of automated insulin delivery systems are making
integrations of advanced technologies more straightforward, and we
are looking forward to exploring these possibilities with Abbott,"
said John Sheridan, president and
CEO of Tandem Diabetes Care. "Our companies share a fierce
dedication to helping expand the available treatment options for
the diabetes community so that more people can experience the
benefits of automated insulin delivery systems, using a combination
of devices they feel best meets their individual needs."
This announcement reflects both Abbott's and Tandem's common
goal to provide people with new ways to manage their diabetes that
can integrate easily into their daily lives.
About the FreeStyle Libre System
Abbott's FreeStyle
Libre, the #1 sensor-based glucose monitoring system used
worldwide1, reads glucose levels through a sensor that
can be worn on the back of the upper arm eliminating the need for
fingersticks2. FreeStyle Libre has changed the lives of
more than 1.5 million people across 46 countries3, and
has secured partial or full reimbursement in 34 countries,
including Canada, France, Ireland, Japan, the United
Kingdom, and the U.S.
For the U.S., important safety information:
https://www.freestylelibre.us/safety-information.html
About the t:slim X2 Insulin Pump
The t:slim X2 pump
was the first insulin pump classified by the FDA in a new device
category called alternate controller enabled (ACE) infusion
pumps4 and the first system approved as compatible with
interoperable continuous glucose monitoring (iCGM) devices. The
system includes advanced features like a large color touchscreen,
rechargeable battery, Bluetooth® wireless technology, USB
connectivity and watertight construction (IPX7).5 It is
capable of remote software updates using a personal computer,
offering the potential for in-warranty users to access new features
as they become available.6
About Abbott
Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals and branded generic medicines. Our
103,000 colleagues serve people in more than 160 countries.
Connect with Abbott at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
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's flagship product, the t:slim X2
insulin pump, is capable of remote software updates using a
personal computer and features integrated continuous glucose
monitoring. Tandem is based in San Diego,
Calif.
Connect with Tandem Diabetes Care at www.tandemdiabetes.com, on
Twitter @tandemdiabetes, on Facebook at
www.facebook.com/TandemDiabetes, and on LinkedIn at
www.linkedin.com/company/TandemDiabetes.
Tandem Diabetes Care is a registered trademark and t:slim X2 is
a trademark of Tandem Diabetes Care, Inc. The Bluetooth word mark
and logos are registered trademarks owned by Bluetooth SIG, Inc.
and any use of such marks by Tandem Diabetes Care, Inc. is under
license.
Forward Looking Statements – Tandem Diabetes Care
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. For
instance, while the parties are currently exploring a business
relationship, there can be no assurance that an agreement will be
reached or that any agreement will be on the terms that are
currently being discussed. Other forward-looking statements relate
to the ability to integrate devices and achieve interoperability
between them. These statements are subject to numerous risks and
uncertainties, including the risks that technical challenges,
clinical or regulatory hurdles or other factors may prevent or
delay integration/interoperability. These and other risks and
uncertainties are identified in Tandem's most recent Annual Report
on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and
other documents filed by the Company 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.
- Data on file, Abbott Diabetes Care. Data based on the number of
users worldwide for the FreeStyle Libre system compared to the
number of users for other leading personal use, sensor-based
glucose monitoring systems.
- Fingersticks are required for treatment decisions when you see
Check Blood Glucose symbol, when symptoms do not match system
readings, when you suspect readings may be inaccurate, or when you
experience symptoms that may be due to high or low blood
glucose.
- Data on file, Abbott Diabetes Care
- U.S. Food and Drug Administration. FDA authorizes first
interoperable insulin pump intended to allow patients to customize
treatment through their individual diabetes management devices;
2019. Available at
https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-insulin-pump-intended-allow-patients-customize-treatment-through.
- Tested to a depth of 3 feet for 30 minutes.
- Additional feature updates are not currently available for the
t:slim X2 pump with Basal-IQ technology and are subject to future
FDA approvals. A prescription and additional training may be
required to access certain future software updates.
View original
content:http://www.prnewswire.com/news-releases/abbott-and-tandem-diabetes-care-exploring-new-integrated-solutions-to-improve-diabetes-management-300938389.html
SOURCE Abbott