The decision is further recognition of Eversense as an
important option for people with diabetes
PARSIPPANY, N.J., Feb. 12,
2024 /PRNewswire/ -- Ascensia Diabetes Care, a
global diabetes care company, and 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,
today announced that Medicare has significantly expanded
access to the Eversense E3 CGM System, the longest lasting CGM
available, with the implementation of Local Coverage Determinations
providing access to implantable CGM for basal only patients, by the
first three Medicare Administrative Contractors (MACs).
Medicare coverage has been expanded for implantable CGMs to
include all people with diabetes using insulin, removing the
previous requirement for multiple insulin administrations per day.
The new policy has also been updated to cover non-insulin-users who
have a history of problematic hypoglycemia. Noridian, Palmetto and
National Government Services (NGS) are the first three MACs to
publish final local coverage determinations (LCD). The earliest MAC
expansion becomes effective on February 25,
2024 and the companies expect the remaining MACs to
finalize their expansion in the near future.
"We welcome this policy change and look forward to bringing this
differentiated CGM option to millions of more Americans through
Medicare," said Rudy Thoms, VP, CGM
Commercial US of Ascensia Diabetes Care, a subsidiary of PHC
Holdings Corporation (TSE 6523). "Eversense E3 is a truly unique
technology and optionality is key in diabetes care, where what
works for one person does not always work for all. In particular,
our Medicare users love that this twice-yearly CGM offers them
unparalleled reliability and flexibility, without the burden of
regular self-insertions and the constant reordering of supplies. It
is important that people with diabetes have the same access to the
benefits of a fully implantable, long-term CGM, as they do to
traditional CGMs [that have a much shorter lifespan], and so we are
thrilled to see this expansion."
Designed by Senseonics (NYSE: SENS) and brought to people by
Ascensia, the Eversense E3 CGM System offers people a fully
implantable option that is highly-differentiated from traditional
CGMs:
- The longest lasting CGM available, with up to 6-month sensor
wear duration and two sensor insertion and removal procedures per
year
- Exceptional accuracy, with a mean absolute relative difference
(MARD) of 8.5%* demonstrated in the
PROMISE Study[1] for the duration of sensor
wear
- The only CGM with a removable transmitter
which can be taken on and off without wasting a sensor or adding a
warm up period†
- The only CGM with predictive on-body alerts
to never miss a critical event, especially at night while sleeping
or when away from your phone
Potential Eversense E3 users can go to
www.ascensiadiabetes.com/eversense to learn more about the program
and find out if they are eligible. Physicians, nurse
practitioners and physician assistants who are interested in
offering the Eversense E3 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.
Ascensia Diabetes Care, the maker of the
CONTOUR® Blood Glucose Monitoring (BGM) System
portfolio and exclusive distributor of
Eversense® Continuous Glucose Monitoring (CGM)
Systems, is a PHC Holdings Corporation (TSE: 6523) company.
Notes for Editors
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global company focused entirely on
helping people with diabetes. Its mission is to empower those
living with diabetes through innovative solutions that simplify and
improve their lives. It is 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, it collaborates closely
with healthcare professionals and other partners to ensure its
products meet the highest standards of accuracy, precision and
reliability, and that it conducts its 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 over 1,300 employees and operations in 31 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
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/.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including statements regarding
expectation for the timing of other MAC expansions of coverage,
statements regarding announced changes taking effect as planned,
statements regarding growing the awareness, adoption, growth and
potential of Eversense, 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 ongoing commercialization of the Eversense product,
uncertainties inherent in PHC Group's development of a dedicated
CGM business, uncertainties inherent in Ascensia's performance and
other commercial initiatives, including the ability to hire, retain
and effectively incentivize the dedicated CGM workforce,
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, 2022, the Quarterly
Report on Form 10-Q for the quarter ended September 30, 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.
* MARD of 9.1% was observed in primary sensor in the
PROMISE Study
† There is no glucose data generated when the
transmitter is removed
[1] 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
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SOURCE Ascensia Diabetes Care