GERMANTOWN, Md., June 21, 2018 /PRNewswire/ -- Senseonics
Holdings, Inc. (NYSE American: SENS) today announced the U.S. Food
and Drug Administration has approved its Premarket Approval (PMA)
application to market the company's Eversense® Continuous Glucose
Monitoring (CGM) System to people with diabetes in the United States. The system is the first and
only CGM system to feature an implantable glucose sensor and
provide long-term continuous monitoring for up to three months.
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8333951-senseonics-continuous-glucose-monitoring-fda-approval/
"We're very pleased to receive this FDA approval that allows us
to make Eversense available in the United
States, as it is in many European markets. With the
parallel trends of wearable personal devices and medical
implantables for people to manage their health, this product
exemplifies the natural evolution for diabetes devices, and
Senseonics is excited to help lead the way," said Tim Goodnow, President and CEO of Senseonics.
"More importantly, we believe the unique features Eversense offers
will help open up CGM to millions of people with diabetes who, up
to this point, have been hesitant to try CGM despite the clear
health benefits it provides."
With 70 percent of patients struggling to control blood glucose
levels and with hypoglycemia prevalent among insulin users,
healthcare professionals believe there are many U.S. patients who
could benefit from CGM. Yet the technology is significantly
underutilized among the millions of insulin-using patients who
could be ideal CGM candidates.
"Research has repeatedly demonstrated the clinical benefits
patients experience with regular CGM use, including improved
glucose control and protection against severe hypoglycemia," said
Steven Edelman, MD, Professor of
Medicine at University of California San
Diego, Founder & Director of Taking Control of Your
Diabetes, and Senseonics Board member. "Despite these benefits, a
significant number of people with diabetes do not use, or have
access to, continuous glucose monitoring. Furthermore, the
data shows that many people who've tried traditional CGM in the
past either don't wear it as often as they should or don't stick
with it for a variety of reasons, including concerns surrounding
sensor accuracy, sensor insertion, and sensor discomfort. So, it's
important that patients have choices and that medical device
companies continue to advance the field of CGM with innovations
that make it easier for the end user."
The Eversense System addresses many of the barriers to CGM use.
The system consists of a fluorescence-based sensor, a smart
transmitter worn over the sensor to facilitate data communication,
and a mobile app for displaying glucose values, trends and alerts.
The sensor, which is inserted subcutaneously in the upper arm by a
physician via a brief in-office procedure, lasts up to three
months, thereby eliminating the need for patients to
self-administer the weekly or biweekly sensor insertions required
by traditional CGM systems.
The system's smart transmitter is light, discreet, and
comfortable to wear. Interpreting glucose data from the
sensor and sending it to the system's mobile application via
Bluetooth, the smart transmitter provides on-body vibratory alerts
for discretion and added safety, and is the only CGM transmitter
that can be removed and recharged without discarding the
sensor.
The Eversense CGM System's PMA application was based on the
previously-reported results of the PRECISE II U.S. pivotal trial in
which Eversense was studied in 90 adults with type 1 or type 2
diabetes at eight clinical centers in the
United States. The study clearly demonstrated the system's
safety and effectiveness over 90 days of continuous glucose sensor
wear. This March, the FDA's Clinical Chemistry and Clinical
Toxicology Devices Panel of independent medical experts voted
unanimously, 8 to 0, that the system not only was safe and
effective, but also that its benefits outweighed the risks.
Webcast and Conference Call Information
Management will host a conference call today beginning at
4:30 p.m. ET to discuss the PMA
approval and commercial activities to support the Eversense product
launch in the U.S. Investors interested in listening to the
conference call may do so by dialing (877) 883-0383 for domestic
callers, or (412) 902-6506 for international callers, using
Conference ID: 5389400. To listen to a live webcast, please visit
the "Investor Relations" section of the Company's website at:
www.senseonics.com. Following the call, a replay will be available
on the Investor Relations section of the Company's website.
About Eversense
The Eversense® Continuous Glucose Monitoring (CGM) System is
indicated for continually measuring glucose levels in persons age
18 and older with diabetes for up to 90 days. It is intended
to complement, not replace, fingerstick blood glucose
monitoring. The sensor insertion and removal is performed by
a physician. The Eversense CGM System is a prescription device;
patients should talk to their doctor to learn more. For
important safety information, see
https://eversensediabetes.com/safety-info/.
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
potential U.S. launch of Eversense, patient adoption of the product
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 development of the market for CGM
products generally, and Eversense in particular, people with
diabetes' perceptions of the benefits of the Eversense System,
patient use of the system, 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 March 31, 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.
Investor Contact:
R. Don Elsey
Chief Financial Officer
301-556-1602
don.elsey@senseonics.com
Media Contacts:
Jeff
Christensen
SignalWest Public Relations
831-566-0275
jeff@signalwestpr.com
Mariesa Kemble
SignalWest Public Relations
608-850-4745
kemblem@mac.com
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SOURCE Senseonics