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, announced that they received FDA approval for the
non-adjunctive indication (dosing claim) for the Eversense Continuous
Glucose Monitoring System. Patients will soon be able to use Eversense
as a replacement for fingersticks to make diabetes treatment decisions
throughout the day. To use the non-adjunctive dosing indication, users
will have to download a new app which will be available in coming months.
“Receiving the non-adjunctive indication from the FDA marks a major
milestone for Senseonics. The Eversense CGM will soon be used as a
replacement to fingersticks to make treatment decisions,” said Tim
Goodnow, President and Chief Executive Officer at Senseonics. “We expect
this will allow our users to more conveniently and confidently live
their lives with fewer interruptions. This approval is also another step
toward providing access to Eversense CGM for people 65 and older, as
non-adjunctive labeling is the first requirement for Medicare coverage.
We look forward to working with the Centers for Medicare & Medicaid
Services leadership team to explore opportunities for Senseonics to
provide Eversense and its benefits to the Medicare population.”
The Eversense CGM 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. In
addition to featuring the first long-term and first implantable CGM
sensor, the system is also first to feature a smart transmitter that
provides wearers with discreet on-body vibratory alerts for high and low
glucose and can be removed, recharged and re-attached to the skin
without discarding the sensor. The sensor is inserted subcutaneously in
the upper arm by a health care provider via a brief in-office procedure.
With the non-adjunctive claim, the Eversense CGM System will still
require 2 fingersticks a day.
“This FDA dosing indication helps reduce the burden that patients face
when managing their diabetes,” said Francine R. Kaufman, MD,
Endocrinologist and Chief Medical Officer at Senseonics. “Patients have
expressed that many of the unique features of Eversense – its long-term
use, removeable transmitter and predictive, on-body vibe alerts – allow
them to be more discreet as they manage their diabetes. In a recent
analysis, we have seen that early Eversense users in the US have
experienced 62% time in the target range for sensor glucose values of
70-180 mg/dL during their first sensor wear. This non-adjunctive dosing
claim is yet another benefit for those patients who want to manage their
diabetes with greater ease and freedom.”
Senseonics plans to launch this new, non-adjunctive product early in the
fourth quarter of 2019. Patients who are interested in getting started
on Eversense can sign up at www.eversensediabetes.com/get-started-today.
Physicians, nurse practitioners or physician assistants interested in
offering the Eversense CGM System for their patients can contact
844-SENSE4U (844-736-7348).
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. The system is indicated for use to
replace fingerstick blood glucose (BG) measurements for diabetes
treatment decisions. Fingerstick BG measurements are still required for
calibration twice per day, and when symptoms do not match CGM
information or when taking medications of the tetracycline class. The
sensor insertion and removal procedures are performed by a health care
provider. The Eversense CGM System is a prescription device; patients
should talk to their health care provider 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 ongoing
commercialization of Eversense in the U.S., the acceleration of the
adoption of Eversense, growing patient and clinician demand for
Eversense, and the potential life-enhancing benefits Eversense offers
people with diabetes, and other statements containing the words
“believe,” “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 in the 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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