The world’s first and only long-term implantable CGM system now
offers patients exceptional accuracy for 6 months
Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and manufacturing of
long-term, implantable continuous glucose monitoring (CGM) systems
for people with diabetes, today announced the approval of the
next-generation Eversense® E3 CGM System by the Food and Drug
Administration (FDA). The Eversense E3, including proprietary
sacrificial boronic acid (SBA) technology to extend longevity to 6
months, is planned to be available to patients in the U.S. through
Ascensia Diabetes Care, Senseonics’ global commercial partner,
beginning in the second quarter of 2022.
“We repeatedly hear from our patients with diabetes that what
they desire is a long-lasting sensor that is also highly accurate,”
said Satish Garg, M.D., Professor of Medicine and Director of the
Adult Diabetes Program at the Barbara Davis Center of the
University of Colorado, and the Principal Investigator of the
PROMISE Study1, which formed the basis for the FDA approval. “The
next generation Eversense E3 System delivers on both. Patients will
appreciate the excellent accuracy of the system and the ability of
the sensor to last 6 months. This is another step forward for
patients who desire to manage their diabetes with all the
advantages of the Eversense CGM with the fully implantable
sensor.”
The Eversense E3 CGM System offers patients:
- Fully implantable third generation sensor, with proprietary SBA
technology to enhance sensor longevity, demonstrating a mean
absolute relative difference (MARD) of 8.5% in the PROMISE
Study.
- Industry leading 6 month sensor wear duration, making Eversense
the longest lasting CGM system available, with essentially two
sensor insertion and removal procedures per year.
- Removable smart transmitter, held in place with a mild
silicone-based adhesive, providing discreet on-body vibratory
alerts and data transmission to a mobile app where glucose values,
trends, and alerts are displayed.
“Further extending the duration of the longest lasting CGM
system to 6 months represents a massive leap forward for patients
and towards our mission of transforming lives in the global
diabetes community,” said Tim Goodnow, PhD, President and Chief
Executive Officer of Senseonics. “The review was delayed by one
year due to COVID-19 priorities and now together with our partner
Ascensia, we can execute our launch plan to deliver the Eversense
E3 CGM System to U.S. patients beginning in the second quarter. We
look forward to initiating Eversense E3 sales and believe that,
with Ascensia’s newly dedicated CGM commercial organization, the
launch of the new 6-month product will establish the foundation for
growth in our installed base later in 2022 and beyond.”
After the extended review during COVID-19, and with its next
generation product now having been approved in the U.S., the
Company concurrently is providing its 2022 financial outlook. The
Company expects full year 2022 global net revenue to be in the
range of $14.0 million to $18.0 million. The Company expects the
majority of its expenses for 2022 to be for research and
development for ongoing feasibility and pivotal clinical trials for
additional products in its product pipeline, including the start of
its 365-day pivotal trial, subject to IDE approval. Additionally,
the Company currently expects to report unaudited revenues of
approximately $4.0 million for the fourth quarter of 2021 and
approximately $13.7 million for the full year ended December 31,
2021. The unaudited balance of cash, cash equivalents and
marketable securities at December 31, 2021 was approximately $182
million. The Company expects to report its full fourth quarter and
fiscal year 2021 financial results after the market close on
Tuesday, March 1, 2022. The preliminary financial results described
herein have not been audited and are subject to adjustment based on
the Company’s completion of year-end financial close processes.
“The Eversense E3 CGM System is an exciting advancement in
diabetes management,” said Francine Kaufman, M.D., Chief Medical
Officer of Senseonics. “We believe patients and providers are
waiting for this step forward. I want to take this opportunity to
thank the PROMISE Study investigators, study participants, and the
Senseonics team for helping us reach this important milestone, and
the diligence of the FDA reviewers in this difficult environment.
We are excited to begin making this next generation product
available in the U.S. to people with diabetes.”
Patients who are interested in getting started on Eversense
today can sign up at www.eversensediabetes.com/get-started-today,
and will be among the first to know when Eversense E3 is
commercially available. Physicians, nurse practitioners and
physician assistants interested in offering the Eversense CGM
System for their patients can sign up at
https://www.ascensiadiabetes.com/eversense/become-a-provider/register/.
Or contact 844-SENSE4U (844-736-7348) to learn more about the first
and only long-term implantable CGM system.
About Eversense
The Eversense® E3 Continuous Glucose Monitoring (CGM) System is
indicated for continually measuring glucose levels for up to 6
months in persons with diabetes age 18 and older. 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 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 trained and certified 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://www.ascensiadiabetes.com/eversense/safety-info/.
About Senseonics
Senseonics Holdings, Inc. is a medical technology company
focused on the development and manufacturing of glucose monitoring
products designed to transform lives in the global diabetes
community with differentiated, long-term implantable glucose
management technology. Senseonics' CGM systems, Eversense®,
Eversense® XL and Eversense® E3 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 2022 revenue
projections, statements concerning the Company’s unaudited
preliminary financial information for the fourth quarter of 2021
and the full year ended December 31, 2021, statements regarding the
timing of the commercial launch of the Eversense E3 product,
statements regarding patient and provider acceptance of the
Eversense product and its attributes, statements regarding future
results for patients, statements regarding growth of the installed
base of Eversense users, statements regarding future research and
study plans, and other statements containing the words “believe,”
“expect,” “intend,” “may,” “projects,” “will,” “planned,” 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
and commercial expansion of a new generation of the Eversense
product, uncertainties inherent in the transition of
commercialization responsibilities to Ascensia and its commercial
initiatives, uncertainties in the development and regulatory
approval processes and timing for the E3 product in Europe,
uncertainties in insurer, regulatory and administrative processes
and decisions, uncertainties in the duration and severity of the
COVID-19 pandemic, 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, 2020 and Senseonics’ other filings with
the SEC under the heading “Risk Factors,” as well as those factors
referenced in Senseonics’ Current Report on Form 8-K filed with the
SEC on February 11, 2022.
The preliminary financial information set forth in this press
release is subject to the completion of the Company’s audit process
and is subject to change. The estimated preliminary results
included in this press release should not be viewed as a substitute
for the Company’s annual financial statements prepared in
accordance with U.S. generally accepted accounting principles.
There can be no assurance that the estimated preliminary results
will be realized, and you are cautioned not to place undue reliance
on the preliminary financial information, which reflects
management’s current expectations and anticipated results of
operations, which are subject to known and unknown risks,
uncertainties and other factors that may cause our actual results,
performance or achievements, market trends, or industry results to
differ materially from those expressed or implied by such
forward-looking statements. 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.
1 Garg SK, MD, Liljenquist D, Bode B, et al. Evaluation of
Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term
Implantable Eversense Continuous Glucose Monitoring System: The
PROMISE Study. DIABETES TECHNOLOGY & THERAPEUTICS 24;2: 2022
DOI: 10.1089/dia.2021.0182
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220211005150/en/
Senseonics Investor Contact Philip Taylor Investor
Relations 415-937-5406 investors@senseonics.com
Senseonics (AMEX:SENS)
Historical Stock Chart
From Apr 2024 to May 2024
Senseonics (AMEX:SENS)
Historical Stock Chart
From May 2023 to May 2024