Senseonics Begins U.S. Commercialization of Eversense Continuous Glucose Monitoring System With First Shipment, First Users &...
August 07 2018 - 8:53AM
Business Wire
Trained and authorized U.S. diabetes clinics begin providing the
first-ever 90-day, long-term CGM system to people with diabetes
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
Eversense® CGM System is now available at trained clinics across
the U.S. and physicians have begun sensor placements with patients.
Concurrently, the company reported that its first commercial payer,
Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare
of New Jersey, has added coverage of the Eversense System to its
Medical Policy.
Today’s milestone announcements mark the company’s rapid entry
into the U.S. commercial market, with the product available to U.S.
patients just six weeks since the FDA approval of the product in
late June.
“Since receiving FDA approval for the Eversense System, we have
experienced tremendous support and interest from physicians and
their patients,” said Tim Goodnow, President and CEO of Senseonics.
“We are thrilled that clinics and users can now benefit from
Eversense, and we’re also pleased to receive our first medical
policy coverage, clearing the way so more people with diabetes can
access this important tool for helping ease the burden of managing
diabetes.”
The Horizon BCBSNJ coverage decision is significant not only
because of the promptness with which it followed the FDA’s product
approval, but also because Horizon serves nearly 4 million covered
lives primarily in New Jersey but also in adjacent states.1
Product shipments began the last week of July to diabetes
clinics across the United States. Physicians and staff have been
subsequently trained and authorized on the Eversense System and
have started their first patients on the system.
"We are pleased to be one of the first clinics to offer
Eversense to our patients after our onboard training," said Bruce
Bode, MD, FACE, Atlanta Diabetes Associates and Clinical Associate
Professor, Department of Medicine Emory University. "I have seen
the benefits of CGM in my own practice, and it’s important to me to
offer the latest technology to my patients. With an implantable
long-term sensor, patients with diabetes can have discretion when
they want it, the convenience of vibratory alerts from the
transmitter, and the comfort of knowing where their glucose is
headed."
To recognize patients receiving their first Eversense sensor
insertion, Senseonics recently initiated Freedom Week, sponsored by
Eversense®, to help patients mark the day they were freed from the
weekly and biweekly self-insertions required by traditional CGM
systems.
While the glucose sensors of traditional CGM systems last 7 to
14 days, the Eversense System is the world’s first and only
long-term CGM system, with a highly accurate implantable sensor
that lasts up to three months. The Eversense System also features a
smart transmitter that is the first that can be removed and
re-adhered without discarding the sensor and the first to provide
discreet on-body vibratory alerts signaling high and low glucose
levels.
Patients who are interested in getting started on Eversense can
sign up at www.eversensediabetes.com/get-started-today. Physicians
interested in becoming an authorized practice can contact
844-SENSE4U (844-736-7348).
1 “The 20 Largest Health Insurance Companies,” Nerdwallet.com,
Aug. 26, 2016
(https://www.nerdwallet.com/blog/health/largest-health-insurance-companies/)
About Senseonics
Senseonics Holdings, Inc. (NYSE American: SENS) 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 FDA PMA
approval for up to 90 days of continuous use and is available in
the United States. The Eversense® CGM XL 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.
About Eversense
The Eversense 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. Light, discreet, and comfortable to wear, the
system's smart transmitter interprets glucose data from the sensor
and sends it to the system's mobile application via Bluetooth, so
patients can review their glucose data to help them make daily
diabetes decisions.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including statements about
physician and patient adoption of the Eversense System 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180807005477/en/
Investor Contact:Senseonics Holdings, Inc.R. Don Elsey,
301-556-1602Chief Financial
Officerdon.elsey@senseonics.comorMedia Contacts:SignalWest
Public RelationsJeff Christensen,
831-566-0275jeff@signalwestpr.com
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