Senseonics Announces the Last Patient Completion of the 365-Day ENHANCE Pivotal Clinical Study
26 Settembre 2023 - 2:05PM
Business Wire
Study Data to Support FDA Submission for the first 365-day
Continuous Glucose Monitoring System
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 the completion of the
ENHANCE Pivotal Clinical Study adult cohort following the recently
completed 365-day visit for the final study patient.
“We are pleased that all patients have completed the testing for
the adult arm of the ENHANCE clinical study. Demonstration of safe
and accurate performance of Eversense® for 365 days in this study
would further validate its ability to facilitate more effective and
longer-term management of diabetes. This represents a major
milestone for Senseonics as we work towards offering the
differentiated benefits of implantable CGM for one full year with
just a single sensor,” said Francine Kaufman, M.D., Chief Medical
Officer of Senseonics. “We appreciate the efforts of the
participating investigators and patients and look forward to
analyzing the data, preparing the submission and working with the
FDA with the goal to secure approval for the planned 365-day
Eversense® system in the coming quarters.”
The ENHANCE study is designed to evaluate the accuracy and
safety of the Eversense system for one year. Over 165 adult
subjects were inserted with Eversense systems in four centers
across the United States. Enrollment for the 365-day sensor
configuration was completed in September 2022. Data gathered in
this study was also used to support the FDA submission for the
integrated continuous glucose monitoring, iCGM, designation earlier
in 2023. An investigational device exemption (“IDE”) supplement was
submitted and approved for expansion of the study to allow for
pediatric patients 14 to 18 years of age and the first pediatric
study participants were enrolled in Q2 2023.
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®,
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 any statements
regarding the advancement of the Eversense system development
program, the use of data from the ENHANCE trial to prepare and
support a submission to the FDA of a longer duration CGM system,
the planned 365-day sensor duration of a submission, the timing of
any potential approval, 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
development and registration of new technology, uncertainties
related to the analysis and results of the ENHANCE study data and
whether such data will support the Company’s planned submissions,
uncertainties in insurer, regulatory and administrative processes
and decisions, uncertainties related to the commercialization of
new technology, 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 June 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.
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Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
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