ABBOTT PARK, Ill. and MILPITAS,
Calif., July 13, 2017
/PRNewswire/ -- Abbott (NYSE: ABT) and Bigfoot Biomedical
today announced that the companies have entered into an agreement
to develop and commercialize diabetes management systems,
integrating Abbott's FreeStyle® Libre
glucose sensing technologyi with Bigfoot's insulin
delivery solutions in the United
States.
This collaboration brings people living with diabetes a
significant step closer to the ultimate goal of eliminating much of
the daily burden of diabetes management. As part of the agreement,
Abbott will provide Bigfoot with the next generation of its
FreeStyle Libre glucose sensing technology. Bigfoot will utilize
this technology in the development of the first-ever personalized,
user-friendly systems intended to optimize insulin delivery without
the need for fingerstick calibration of a glucose sensor.
"Diabetes is increasing at record rates globally. There is a
significant demand for tools that are intuitive and easy to use to
help people take control of this complicated, challenging
condition, but innovation in this area has been slow,"
said Jared Watkin, senior vice president, Diabetes Care,
Abbott. "Together with Bigfoot, we are challenging conventional
methods of diabetes management by bringing together our expertise
in superior glucose monitoring technology with a best-in-class
insulin delivery system that is designed with the patient in mind.
This will fundamentally transform the way diabetes is managed."
All people with Type 1 diabetes, and nearly one third of people
with Type 2 diabetes, must inject insulin to manage their glucose –
that's more than 6 million peopleii in the U.S. alone.
Bigfoot and Abbott both share a vision to simplify the use of
diabetes management systems for these insulin users: a goal that
moves beyond technology and into accessibility and cost reduction
for individuals, their health care providers and payers.
"Bigfoot is committed to solving the hard problems inherent in
blending consumer technology, enterprise systems and Class III
medical devices in an effort to design an easy-to-use system for
people with diabetes," said Jeffrey
Brewer, Bigfoot Biomedical president and chief executive
officer. "Both Abbott and Bigfoot understand the real-world use of
diabetes devices. A no-calibration glucose sensor is the final
piece of the puzzle needed to enable consumer-friendly and
accessible integrated insulin delivery systems."
Bigfoot has both injection and infusion pump-based insulin
delivery systems in development. These investigational systems
utilize intuitive design, Internet of Things connectivity,
smartphone technology and machine learning automation to adjust
insulin delivery or dosing with the intent to keep glucose levels
in an optimal range. Bigfoot anticipates initiating a pivotal trial
incorporating FreeStyle Libre technology in 2018 at clinical
research sites across the United
States.
Abbott's FreeStyle Libre system was introduced
across Europe in 2014, and is now available in more than
35 countries and used by more than
300,000iii people with diabetes around the world.
Two published clinical trialsiv and real-world
evidence from more than 50,000 usersv show that
people who use the FreeStyle Libre system scan their glucose levels
an average of at least 15 times per day. The studies show that
people who scan more frequently spend less time in hypoglycemia
(low blood sugar) or hyperglycemia (high blood sugar) while having
improved average glucose levels, demonstrating improved glucose
control overall.
"Our companies have a shared commitment to developing products
that are patient focused – simple, convenient, discreet, affordable
and provide actionable information," said Brewer. "We could
not be more excited to be collaborating with Abbott's outstanding
team in bringing new innovations to people with diabetes."
In the U.S., the FreeStyle Libre system is currently pending
approval by the U.S. Food and Drug Administration.
About the Agreement
Under the terms of the
agreement:
- Abbott will supply glucose measurement sensors for all of
Bigfoot's insulin delivery systems in the U.S. as the exclusive
sensors for those systems.
- Bigfoot will develop and commercialize multiple systems using
Abbott's FreeStyle Libre sensor technology, including systems
designed to perform auto-titration for Bigfoot's connected insulin
injection devices, as well as automated insulin delivery using
Bigfoot's insulin infusion platform.
- Financial terms are not being disclosed.
About Bigfoot Biomedical, Inc.:
Bigfoot Biomedical was
founded by a team of people with a personal connection to Type 1
diabetes and, with its insulin delivery services, seeks to change
the paradigm of care for insulin-requiring diabetes by leveraging
data, connectivity, automation, and machine learning to reduce the
burden on people with diabetes and maximize the leverage of health
care providers. Learn more at bigfootbiomedical.com. Follow us on
Twitter @BigfootBiomed and Facebook.
About Abbott:
At Abbott, we're committed to helping
people live their best possible life through the power of health.
For more than 125 years, we've brought new products and
technologies to the world -- in nutrition, diagnostics, medical
devices and branded generic pharmaceuticals -- that create more
possibilities for more people at all stages of life. Today, 94,000
of us are working to help people live not just longer, but better,
in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook
at www.facebook.com/Abbott and on Twitter
@FreeStyleDiabet, @AbbottNews and @AbbottGlobal.
__________________________________
i Pending FDA approval. Not available for sale in the
U.S.
ii
https://professional.diabetes.org/sites/professional.diabetes.org/files/media/fast_facts_12-2015a.pdf
iii Information on file, Abbott Diabetes Care
iv Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger
J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia
in Type 1 diabetes: a multicentre, non-masked, randomised
controlled trial [published online September
12, 2016]. Lancet. 2016; Haak T, Hanaire H, Ajjan R et al.
Flash glucose-sensing technology as a replacement for blood glucose
monitoring for the management of insulin-treated Type 2 diabetes: a
multicenter, open-label randomized controlled trial. Diabetes Ther.
2017; 8: 55-73
v Dunn, T., Xu, Y., & Hayter, G. (2017). Evidence of
a Strong Association Between Frequency of Flash Glucose Monitoring
and Glucose Control Measures During Real-World Usage. Diabetes
Technology and Therapeutics, 19(S1). Doi:
10.1D89/dia.2017.2525.abstracts
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SOURCE Abbott