The first fully implantable continuous glucose
monitors can now be integrated with insulin pumps as part of an
automated insulin delivery system
Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and manufacturing of
long-term, implantable continuous glucose monitoring (CGM) systems
for people with diabetes and Ascensia Diabetes Care, a global
diabetes care company, announced that Eversense® has been granted
an integrated CGM (iCGM) designation by the US Food and Drug
Administration (FDA).
As the first fully implantable device in the category, Eversense
has been authorized to be marketed as an iCGM through the FDA’s De
Novo pathway, by establishing the special controls that will serve
as a predicate device for 510(k) submissions in the future for
devices of the same type.
iCGM status indicates that Senseonics’ Eversense iCGM product
can integrate with compatible medical devices, including insulin
pumps as part of an automated insulin delivery (AID) system. The
companies plan to advance partnership discussions with various pump
manufacturers, with plans to offer people who choose to integrate
their diabetes devices a new interoperable CGM option that is
exceptionally well suited for AID systems. This is because
Eversense addresses common limitations of AID systems outlined in
the 2022 Consensus Report of the Joint Diabetes Technology Working
Group of the European Association for the Study of Diabetes and the
American Diabetes Association.1
“Managing diabetes is all about personal choice and finding the
options that best support an individual to live a healthier, less
interrupted life,” said Brian Hansen, President of CGM at Ascensia
Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523).
“For many, one of these choices is to take some of the calculation
out of diabetes management by integrating their CGM with an insulin
pump as part of an AID system. We are pleased that Eversense has
been granted iCGM designation by the FDA, so that people who desire
this integration in the future will be able to choose Eversense and
access its unique benefits.”
“The iCGM designation has been a core component of our strategic
initiatives to advance our pipeline, and we are excited to move
forward with the next steps to accelerate integration of the
world’s longest lasting CGM with leading insulin devices,” said Tim
Goodnow, PhD, President and Chief Executive Officer of Senseonics.
“The rigorous data requirements for this FDA designation highlight
our team's advanced engineering expertise in developing a CGM that
meets high standards. Our confidence in our differentiated
technology is high, as there is a tremendous opportunity with iCGM
to deliver value and provide substantial benefits to diabetes
patients. As we look ahead, we are focused on progressing our
partnership discussions and software developments, and look forward
to providing more updates.”
Designed by Senseonics and brought to people with diabetes by
Ascensia, the Eversense CGM System offers a fully implantable
option that is exceptionally well suited for AID therapy:
- The longest lasting CGM available with 6 months of wear time
and only one insertion and one “Day 1”
- Most accurate CGM in critical low glucose ranges2,3,4,5 with
essentially no compression lows6
- Most dependable CGM alert detection to support accurate
corrections in real time7
- The only CGM with a removable transmitter which can be taken on
and off without wasting a sensor or adding a warm up period†
Potential Eversense users can go to
www.ascensiadiabetes.com/eversense to learn more. Physicians, nurse
practitioners and physician assistants who are interested in
offering the Eversense CGM System can sign up at
https://www.ascensiadiabetes.com/eversense/become-a-provider/.
Alternatively, contact 1-844-SENSE4U (1-844-736-7348) to learn more
about the first and only long-term implantable CGM system.
† There is no glucose data generated when the transmitter is
removed
1 Sherr JL, Heinemann L, Fleming GA, et al. Automated insulin
delivery: benefits, challenges, and recommendations. A Consensus
Report of the Joint Diabetes Technology Working Group of the
European Association for the Study of Diabetes and the American
Diabetes Association. Diabetologia. 2023;66(1):3-22.
doi:10.1007/s00125-022-05744-z
2 Garg S. et al. Evaluation of Accuracy and Safety of the
Next-Generation Up to 180-Day Long-Term Implantable Eversense
Continuous Glucose Monitoring System: The PROMISE Study. Diabetes
Technology & Therapeutics 2021; 24(2): 1-9.DOI:
10.1089/dia.2021.0182
3 Barnard KD, Kropff J, Choudhary P, et al. Acceptability of
Implantable Continuous Glucose Monitoring Sensor. J Diabetes Sci
Technol. 2018;12(3):634-638. doi:10.1177/1932296817735123
4 Boscari F, Vettoretti M, Cavallin F, et al. Implantable and
transcutaneous continuous glucose monitoring system: a randomized
cross over trial comparing accuracy, efficacy and acceptance. J
Endocrinol Invest. 2022;45(1):115-124.
doi:10.1007/s40618-021-01624-2
5 Hanson K, Kipnes M, Tran H. Comparison of Point Accuracy
Between Two Widely Used Continuous Glucose Monitoring Systems. J
Diabetes Sci Technol. Published online January 8, 2024.
doi:10.1177/19322968231225676
6 Christiansen MP, Klaff LJ, Brazg R, et al. A Prospective
Multicenter Evaluation of the Accuracy of a Novel Implanted
Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther.
2018;20(3):197-206. doi:10.1089/dia.2017.0142
7 Eversense E3 User Manual LBL-4002-01-001 Rev B 02/2022
Notes for Editors
About Senseonics
Senseonics Holdings, Inc. ("Senseonics") is a medical technology
company focused on the development and manufacturing of glucose
monitoring products designed to transform lives in the global
diabetes community with differentiated, long-term implantable
glucose management technology. Senseonics' CGM system Eversense® E3
includes a small sensor inserted completely under the skin that
communicates with a smart transmitter worn over the sensor. The
glucose data are automatically sent every 5 minutes to a mobile app
on the user's smartphone.
About Eversense
The Eversense® E3 Continuous Glucose Monitoring (CGM) System is
indicated for continually measuring glucose levels for up to 180
days in persons with diabetes age 18 and older. The system is
indicated for use to replace fingerstick blood glucose (BG)
measurements for diabetes treatment decisions. Fingerstick BG
measurements are still required for calibration primarily one time
a day after day 21, and when symptoms do not match CGM information
or when taking medications of the tetracycline class. The sensor
insertion and removal procedures are performed by a health care
provider. The Eversense E3 CGM System is a prescription device;
patients should talk to their health care provider to learn more.
For important safety information, see
https://www.ascensiadiabetes.com/eversense/safety-info/.
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global company focused entirely on
helping people with diabetes. Our mission is to empower those
living with diabetes through innovative solutions that simplify and
improve their lives.
We are home to the world-renowned CONTOUR® portfolio of blood
glucose monitoring systems and the exclusive global distribution
partner for the Eversense® Continuous Glucose Monitoring Systems
from Senseonics. These products combine advanced technology with
user-friendly functionality to help people with diabetes manage
their condition and make a positive difference to their lives. As a
trusted partner in the diabetes community, we collaborate closely
with healthcare professionals and other partners to ensure our
products meet the highest standards of accuracy, precision and
reliability, and that we conduct our business compliantly and with
integrity.
Ascensia is a member of PHC Group and was established in 2016
through the acquisition of Bayer Diabetes Care by PHC Holdings
Corporation. Ascensia products are sold in more than 100 countries.
Ascensia has around 1,400 employees and operations in 29
countries.
For further information, please visit the Ascensia Diabetes Care
website at: http://www.ascensia.com
About PHC Holdings Corporation
PHC Holdings Corporation (TSE 6523) is a global healthcare
company with a mission of contributing to the health of society
through healthcare solutions that have a positive impact and
improve the lives of people. Its subsidiaries (referred to
collectively as PHC Group) include PHC Corporation, Ascensia
Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience
Corporation, Mediford Corporation, and Wemex. Together, these
companies develop, manufacture, sell and service solutions across
diabetes management, healthcare solutions, life sciences and
diagnostics. PHC Group’s consolidated net sales in FY2022 were JPY
356.4 billion with global distribution of products and services in
more than 125 countries. www.phchd.com
©2024 Ascensia Diabetes Care Holdings AG. All right reserved.
Ascensia, the Ascensia Diabetes Care logo and Contour are
trademarks and/or registered trademarks of Ascensia Diabetes Care
Holdings AG.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including statements regarding
announced changes taking effect as planned, statements regarding
growing the awareness, adoption, growth and potential of Eversense,
statements regarding potential plans and prospects for partnerships
with pump manufacturers, for integrated AID systems incorporating
Eversense, for the attributes and value to patients of any such
systems, and for regulatory submissions and approaches for the
Eversense product, and other statements containing the words
"believe," "expect," "intend," "may," "projects," "will,"
"planned," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: uncertainties in insurer, regulatory
and administrative processes and decisions, uncertainties inherent
in the development of new technology, uncertainties related to the
reliance on discussions and arrangements with pump manufacturers
and other third parties, uncertainties inherent in the ongoing
commercialization of the Eversense product, uncertainties inherent
in Ascensia's performance and other commercial initiatives,
uncertainties relating to the current economic environment and such
other factors as are set forth in the risk factors detailed in
Senseonics' Annual Report on Form 10-K for the year ended December
31, 2023 and Senseonics' other filings with the SEC under the
heading "Risk Factors." In addition, the forward-looking statements
included in this press release represent Senseonics' views as of
the date hereof. Senseonics anticipates that subsequent events and
developments will cause Senseonics' views to change. However, while
Senseonics may elect to update these forward-looking statements at
some point in the future, Senseonics specifically disclaims any
obligation to do so except as required by law. These
forward-looking statements should not be relied upon as
representing Senseonics' views as of any date subsequent to the
date hereof.
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Senseonics Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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