Senseonics Announces the First Patient Implant of the Eversense E3 CGM System in the U.S.
April 06 2022 - 4:34PM
Business Wire
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, its
commercialization partner, have announced the first commercial
patient has been implanted with Eversense® E3, kicking off the
launch of the next-generation CGM System in the U.S. The Eversense
E3 Sensor was approved by the FDA in February and is the longest
lasting CGM available in the U.S.
“The accuracy, duration and implantable form of Eversense E3
combine to provide diabetes patients confidence and convenience
never available previously,” said Bantwal S. Baliga, MD: MRCP
(U.K.), Director of East Alabama Endocrinology, and the first
physician to insert the extended life sensor now that it is
commercially available. “This next-generation implantable system
has been designed with patients in mind by offering 6-months of
sensor life. It also offers unique benefits like discrete on-body
vibratory alerts through a removable transmitter that provides
patients wear time flexibility without ever having to waste a
sensor. It is an important offering for patients wanting accuracy,
protection, and convenience.”
The Eversense E3 CGM System, developed by Senseonics and brought
to people with diabetes by Ascensia Diabetes Care, offers:
- The longest lasting CGM available, with a 6-month sensor wear
duration, with essentially 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 for the duration
of sensor wear
- A fully implantable fluorescence-based sensor, with a removable
smart transmitter that provides discreet on-body vibratory alerts
and transmits data to a mobile app
- Reduced calibrations compared to the previous generation
Eversense CGM Systems
“We are pleased with the patient and health care provider
excitement surrounding the Eversense E3 launch,” said Tim Goodnow,
President and Chief Executive Officer. “Today marks a major
milestone in the history of diabetes care, advancing our Eversense
CGM offering so that patients with diabetes can live more freely.
We are excited the Eversense E3 is now available to millions of
diabetes patients across the U.S.”
Patients who are interested in getting started with Eversense
now can sign up at www.eversensediabetes.com/get-started-today.
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 844-SENSE4U (844-736-7348) to learn more
about the first and only long-term implantable CGM system.
About Eversense
The Eversense® E3 Continuous Glucose Monitoring (CGM) System is
indicated for continually measuring glucose levels for up to 6
months 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 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 trained and certified health care provider. The
Eversense 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 Senseonics
Senseonics Holdings, Inc. 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®,
Eversense® XL 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.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including the perception of and
benefits to be received by patients and the number of patients to
whom Eversense will be available, 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
commercial launch of Eversense E3 CGM system and commercial
expansion of the Eversense product, uncertainties inherent in the
transition of commercialization responsibilities to Ascensia and
its commercial initiatives, uncertainties in insurer, regulatory
and administrative processes and decisions, uncertainties in the
duration and severity of the COVID-19 pandemic, 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, 2020 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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INVESTOR CONTACT Philip Taylor Investor Relations
415-937-5406 investors@senseonics.com
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