Senseonics Announces First Study Participant Implanted in the U.S. as Part of the PROMISE 180-Day Sensor Clinical Study & the...
January 03 2019 - 4:45PM
Business Wire
Senseonics Holdings, Inc. (NYSE-American: SENS), a medical
technology company focused on the development and commercialization
of a long-term, implantable continuous glucose monitoring (CGM)
system for people with diabetes, today announced that the extended
life Eversense® XL sensor that lasts up to 180 days has been
implanted in the first U.S. study participant as part of the
clinical trial for pre-market application submission to the Food
and Drug Administration.
The PROMISE Clinical Study is intended to evaluate the safety
and efficacy of the Eversense CGM system in people with diabetes
over a 180-day period. Approximately 180 study participants at up
to 15 locations across the United States are planned to enroll in
the study. The Eversense XL sensor previously received the CE Mark
and is currently marketed to patients across the European
Union.
Senseonics also announced that the company has completed its
submission of PMA supplements to the FDA to secure an insulin
dosing claim and to remove the contraindication related to the
Magnetic Resonance Imaging (MRI) exposure on the 90-day system
which is currently available in the United States.
“I am thrilled to be able to offer a long term implantable
sensor to my patients through the PROMISE 180-day Clinical Study,”
said Dr. Mark Christiansen, Co-Medical Director of Diablo Clinical
Research and the first physician to insert the extended life
long-term sensor. “We are looking forward to providing patients six
months of continuous sensing and the potential benefits of a
long-term sensor.”
“We are pleased to have enrolled the first participant in this
important study which demonstrates our continued progress in
transforming CGM technology. This is the first study in the US in
which participants are implanted with a single sensor designed to
produce accurate continuous glucose measurements for half of a
year,” said Tim Goodnow, President and Chief Executive Officer.
“Our submission of the Supplements to secure the dosing claim and
to remove the MRI contraindication for the current 90-Day Eversense
system are significant step forward in reducing the burden of
diabetes management and providing patients peace of mind.”
About Senseonics
Senseonics Holdings, Inc. is a medical technology company
focused on the design, development and commercialization of
transformative glucose monitoring products designed to help people
with diabetes confidently live their lives with ease. From its
inception, Senseonics has been advancing the integration of novel,
fluorescence sensor technology with smart wearable devices. The
Eversense® CGM System received PMA approval from the FDA for up to
90 days of continuous use and is available in the United States.
The Eversense® XL CGM System received CE mark for up to 180 days of
continuous use and is available in Europe. For more information on
Senseonics, please visit www.senseonics.com.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including statements about
clinical development of longer life sensors or system enhancements,
label expansion and changes, additional regulatory approvals, and
other statements containing the words “expect,” “intend,” “may,”
“projects,” “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: uncertainties
relating to study conduct and results, uncertainties in the
clinical development and regulatory approval processes,
uncertainties inherent in the commercial launch and commercial
expansion of the product, 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, 2017, Senseonics’ Quarterly
Report on Form 10-Q for the quarter ended September 30, 2018, 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: https://www.businesswire.com/news/home/20190103005730/en/
INVESTOR CONTACTLynn Lewis or Philip TaylorInvestor
Relations415-937-5406investors@senseonics.com
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