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 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 glycemic 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.
Senseonics Investor Contact
Jeremy FefferLifeSci
Advisorsinvestors@senseonics.com
Ascensia Communications
Contact
Lorraine ChandlerHead of Corporate
CommunicationsLorraine.chandler@ascensia.com
Mercy Communications
Contact
Bethany Pope 314-251-4472 Mercy Media
RelationsBethany.Pope@Mercy.net
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