The decision is further recognition of
Eversense as an important option for people with diabetes
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 American: 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 Study1 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.
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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240212855948/en/
For more media enquiries, please contact:
ADC Communications Contact Lorraine Chandler
lorraine.chandler@ascensia.com
Senseonics Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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