Senseonics' Eversense 365 is approved in the
US as an integrated continuous glucose monitoring (iCGM) system for
people with Type 1 and Type 2 diabetes aged 18 and older
Commercial launch by Ascensia Diabetes Care
underway with a new campaign to highlight the unique benefits of
having just one CGM for one full year
GERMANTOWN, Md. and ST. LOUIS, Oct. 10,
2024 /PRNewswire/ -- Senseonics Holdings, Inc.
(NYSE American: SENS) ("Senseonics" or the "Company"), a medical
technology company focused on the development and manufacturing of
long-term, implantable continuous glucose monitoring (CGM) systems
for people with diabetes, and Mercy, a leading healthcare
system, today announced that the first commercial patient
received the next-generation Eversense® 365 CGM system.
This milestone, part of the company's previously announced
collaboration with Mercy, marks the world's first commercial use of
Eversense 365, the only CGM to provide one-year of accurate
monitoring with minimal interruptions.
"This is a pivotal moment for people with
diabetes..."
This patient and those who follow, along with their doctors,
will be able to monitor glucose levels and trends for a full year,
with no requirement for additional sensor replacements and only one
calibration per week. Eversense 365 offers patients a truly
differentiated CGM experience, enabling confident decisions,
long-term peace of mind and enhanced quality of life with just one
CGM. It also helps people to overcome common frustrations and
interruptions experienced with traditional, short-term CGMs that
are indicated to last just 10-14 days. Senseonics and Mercy expect
this significant breakthrough in diabetes technology and management
to improve gylcemic control for patients, reduce distress
associated with managing diabetes and lower overall healthcare
costs for providers and payers.
"Without the technology, patients deal with constant finger
pricks to test their glucose or have sensors that need to be
replaced every few days," said Dr. Jeff
Ciaramita, Mercy's president of specialty service lines.
"This is a pivotal moment for people with diabetes because this
groundbreaking technology allows patients a more convenient and
reliable way to manage their condition for an entire year with a
single sensor. As Mercy strives to make care easy for our patients,
what better way than to be the first in the world to offer
Eversense 365."
Eversense 365 was approved by the U.S. Food and Drug
Administration last month. The commercial launch, which has now
begun, is being managed by Senseonics global commercial partner,
Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation
(TSE 6523). Mercy serves 3 million patients annually and expects
that approximately 30,000 of Mercy's patients could benefit from a
CGM system.
"We are thrilled to see the successful first commercial
insertion of the Eversense 365 CGM system at Mercy," said
Francine Kaufman, M.D. Senseonics'
chief medical officer. "Eversense 365 addresses many of the
challenges that patients experience with traditional, short-term
CGMs and we are excited to see the real-world benefit it can have
as it is rolled out to patients across the U.S. We expect that
health systems across the country will recognize the benefits that
Mercy has embraced and can adopt Eversense 365 towards enhancing
the quality of care while reducing the cost of care. Our goal is to
make this life-changing technology accessible to as many patients
as possible through collaborations with forward-thinking health
care leaders such as Mercy."
"This long-term monitoring solution empowers patients with
real-time data and enables our clinicians to deliver proactive,
personalized care, ultimately leading to better health and quality
of life for those we serve," Dr. Ciaramita said. "By adopting
Eversense 365, we're enhancing our commitment to value-based care
‒driving to improve patient outcomes while reducing overall health
care costs."
To learn more about Eversense 365 and for additional information
about when the system will be available, go to
www.eversensecgm.com. Physicians, nurse practitioners and physician
assistants who are interested in offering the Eversense CGM System
can sign up at https://provider.eversensecgm.com/contact-us/.
Alternatively, contact 1-844-SENSE4U (1-844-736-7348) to learn more
about the first and only long-term implantable CGM system.
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 systems Eversense® 365 and Eversense®
E3 include 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® Continuous Glucose Monitoring (CGM) Systems are
indicated for continually measuring glucose levels for up to 365
days for Eversense® 365 and 180 days for Eversense® E3 in persons
with diabetes age 18 and older. The systems are 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 per week after day 14 for
Eversense® 365 and one time per day after day 21 for Eversense® E3,
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 CGM Systems are prescription devices; patients should
talk to their health care provider to learn more. For important
safety information, see
https://www.eversensediabetes.com/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 FY2023 were
JPY 353.9 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.
About Mercy
Mercy, one of the 20 largest U.S. health systems and
named the top large system in the U.S. for excellent
patient experience by NRC Health, serves millions annually with
nationally recognized care and one of the nation's largest and
highest performing Accountable Care Organizations in quality and
cost. Mercy is a highly integrated, multi-state health care system
including more than 50 acute care and specialty (heart, children's,
orthopedic and rehab) hospitals, convenient and urgent care
locations, imaging centers and pharmacies. Mercy has over 900
physician practice locations and outpatient facilities, more than
4,500 physicians and advanced practitioners and 50,000 co-workers
serving patients and families
across Arkansas, Kansas, Missouri and Oklahoma.
Mercy also has clinics, outpatient services and outreach ministries
in Arkansas, Louisiana, Mississippi and Texas.
In fiscal year 2023 alone, Mercy provided more than half a billion
dollars of free care and other community benefits, including
traditional charity care and unreimbursed Medicaid.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including statements regarding
plans and timing for the commercial launch of the 356-day system,
statements regarding the attributes experienced by people with
diabetes and differentiating the system from short-term CGM, and
statements regarding the experience, potential results and
decisions of health care systems, 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 inherent in the
execution of the independent business unit of Ascensia Diabetes
Care, the Company's commercialization partner for Eversense, and
other commercial initiatives, uncertainties in insurer, regulatory
and administrative processes and decisions, uncertainties inherent
in the development and registration and roll-out of new technology
and solutions, uncertainties inherent in finalizing integration and
commercial terms and coordinations with health systems and other
new collaboration partners and third parties, uncertainties
inherent in the ongoing commercialization of the Eversense product
and the expansion of the Eversense product, uncertainties relating
to the current economic environment and such other factors as are
set forth in the risk factors detailed in Senseonics' Quarterly
Report on Form 10-Q for the quarter ended June 30, 2024 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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SOURCE Mercy