Senseonics submits Eversense® Continuous Glucose Monitoring system PMA to FDA
October 27 2016 - 4:49PM
Business Wire
First implantable CGM system to undergo regulatory
review
Senseonics Holdings, Inc. (NYSE-MKT: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 it has
submitted to the U.S. Food and Drug Administration (FDA) a
Premarket Approval (PMA) application for its Eversense® CGM
system.
“The submission of our PMA marks a significant milestone toward
meeting our goal of bringing an accurate, reliable and long-lasting
CGM system to people with diabetes in the United States,” said Tim
Goodnow, PhD., CEO and President of Senseonics. “We look forward to
working with the FDA to receive approval as quickly as
possible.”
As previously reported, the PRECISE II U.S. pivotal trial
enrolled 90 adults with Type 1 or Type 2 diabetes at eight clinical
centers. The objective of the study was to demonstrate the safety
and effectiveness of the Eversense CGM system over 90 days of
continuous glucose sensor wear. Participants in the study used the
system’s smart transmitter and mobile app at home for the next 90
days. Calibration was performed twice a day, and Sensor glucose
readings were calculated prospectively, but real-time glucose
readings and trends were not made available to participants. Clinic
visits were scheduled at approximately 30-day intervals in order to
obtain lab reference glucose values for comparison with the sensor
values and to evaluate hyperglycemic and hypoglycemic challenges in
a controlled setting.
Results of the PRECISE II study will be presented at this year’s
Diabetes Technology Meeting in Bethesda, Maryland on November 10,
2016.
Upon receiving FDA regulatory approval, Senseonics plans to
initiate sales in the United States. The company received its CE
mark in May 2016 and is currently marketing the Eversense CGM
System in select European countries.
Eversense CGM System is an Investigational Device and is limited
by United States law to investigational use.
About Senseonics
Senseonics Holdings, Inc. is a medical technology company
focused on the design, development and commercialization of glucose
monitoring products designed to help people with diabetes
confidently live their lives with ease. Senseonics’ first
generation continuous glucose monitoring (CGM) system, Eversense®,
includes a small sensor, smart transmitter and mobile application.
Based on fluorescence sensing technology, the sensor is designed to
be inserted subcutaneously and communicate with the smart
transmitter to wirelessly transmit glucose levels to a mobile
device. After insertion, the sensor is designed to continually and
accurately measure glucose levels. For more information on
Senseonics, please visit www.senseonics.com.
SAFE HARBOR STATEMENT
Certain statements contained in this press release, other than
statements of fact that are independently verifiable at the date
hereof, may constitute “forward-looking statements.” These
forward-looking statements reflect Senseonics’ current views about
its plans, intentions, expectations, strategies and prospects,
including statements concerning the FDA review, and potential
approval, of the PMA, and the United States commercial launch of
Eversense, which are based on the information currently available
to Senseonics and on assumptions Senseonics has made. Although
Senseonics believes that its plans, intentions, expectations,
strategies and prospects as reflected in or suggested by those
forward-looking statements are reasonable, Senseonics can give no
assurance that the plans, intentions, expectations or strategies
will be attained or achieved. Furthermore, actual results may
differ materially from those described in the forward-looking
statements and will be affected by a variety of risks and factors
that are beyond Senseonics’ control, including those risks and
uncertainties more fully described in the section entitled “Risk
Factors” in Senseonics’ Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on February 19, 2016, the
Quarterly Report on Form 10-Q filed with the SEC on August 9, 2016
and its other SEC filings. Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. The statements
made in this press release speak only as of the date stated herein,
and subsequent events and developments may cause Senseonics’
expectations and beliefs to change. While Senseonics may elect to
update these forward-looking statements publicly at some point in
the future, Senseonics specifically disclaims any obligation to do
so, whether as a result of new information, future events or
otherwise, except as required by law.
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Senseonics Holdings, Inc.R. Don ElseyChief Financial
Officer301-556-1602don.elsey@senseonics.com
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