Senseonics Announces Date for FDA Advisory Panel
March 01 2018 - 8:45AM
Business Wire
Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and commercialization
of Eversense®, a long-term, implantable continuous glucose
monitoring (CGM) system for people with diabetes, today announced
the U.S. Food and Drug Administration (FDA) Clinical Chemistry and
Clinical Toxicology Devices Panel is scheduled to review the
premarket approval application (PMA) for Eversense on Thursday,
March 29, 2018.
The Eversense PMA application contains data from Senseonics’
U.S. PRECISE II study. The study, considered one of the largest
studies of a CGM system in the world, includes over 2 million
sensor glucose readings, from 90 patients at eight clinical centers
during the full 90-day study duration.
“The scheduling of the advisory panel represents a meaningful
milestone toward offering patients in the U.S. a long term,
implantable CGM system,” stated Tim Goodnow, President and Chief
Executive Officer of Senseonics. “We are excited for the
opportunity to discuss the data in support of the Eversense PMA
with the panel. We believe the Eversense system’s value to people
with diabetes will resonate with the panel as it has with users in
Europe .”
About Senseonics
Senseonics Holdings, Inc. is a medical technology company
focused on the design, development and commercialization of
transformational glucose monitoring products designed to help
people with diabetes confidently live their lives with ease.
Senseonics' CGM systems, Eversense and Eversense XL, 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 statements about the
timing of the advisory panel and the potential U.S. launch of
Eversense and other statements containing the words “expect,”
“intend,” “may,” “will,” 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: the
uncertainties related to the panel being held as scheduled, the
recommendation of the panel with respect to the PMA, the ultimate
decision by the FDA with respect to the PMA 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, 2016,
Senseonics’ Quarterly Report on Form 10-Q for the quarter ended
September 30, 2017 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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version on businesswire.com: http://www.businesswire.com/news/home/20180301005841/en/
Investors:Senseonics Holdings, Inc.R. Don Elsey,
301.556.1602Chief Financial Officerdon.elsey@senseonics.com
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