Senseonics Announces FDA Approval to Expand Eversense® CGM Certification to Nurse Practitioners and Physician Assistants
--Now all qualified healthcare providers can perform sensor placements
on patients--
GERMANTOWN, Md.--(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 has announced that the Eversense® Continuous
Glucose Monitoring (CGM) System has received FDA approval for qualified
health care providers to be trained and certified to provide patients
with the highly accurate sensor that lasts up to three months.
Previously, the sensor insertion and removal procedure could only be
performed by trained physicians.
“We are pleased with this FDA approval, we can now include nurse
practitioners and physician assistants in the growing list of diabetes
care professionals who can be certified to place the Eversense CGM
System,” said Tim Goodnow, President and CEO of Senseonics. “We believe
that allowing additional health care providers to perform the in-office
placement procedure for Eversense CGM will enable broader access to
patients for this compelling long-term diabetes management technology.”
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 that can be removed, recharged and re-adhered without
discarding the sensor. The sensor can now be inserted subcutaneously in
the upper arm by a physician, physician assistant* or nurse
practitioner* via a brief in-office procedure.
"As a nurse practitioner, I appreciate that the FDA is recognizing the
importance of advanced practitioners in a physician practice and in the
care continuum," said KC Arnold, ANP, from The Diabetes Center in Ocean
Springs, MS. “Many health care providers are ready and willing to learn
and perfect these types of in-office procedures with the goal of helping
more patients in their practice manage their diabetes with the latest
technology available on the market.”
In addition to medical doctors, physician assistants and nurse
practitioners will be able to file claims with health insurance plans
under established CPT codes. Depending on the health plan contracts and
state-by-state regulation, physician assistants and nurse practitioners
may receive a percentage of the typical reimbursement provided to a
medical doctor. Once physician assistants and nurse practitioners are
trained on sensor placement, the Eversense CGM system will be more
widely available across the U.S. market for patients with diabetes.
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).
*Scope of practice may vary by state.
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 health care provider. 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 expanded
commercialization, use and reimbursement of Eversense, label expansion,
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 inherent in the commercial launch of Eversense 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
June 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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Source: Senseonics Holdings, Inc.