New Clinical Data Demonstrating the Safety and Accuracy of Eversense through 365 Days Presented at the American Diabetes Association 83rd Scientific Sessions
26 Juin 2023 - 1:30PM
Business Wire
Eversense E3 system can provide accurate performance through
365-day period Superior glucose outcomes achieved with use of
Eversense E3 CGM
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 highlighted new clinical data
presented at the American Diabetes Association 83rd Scientific
Session. Two studies were presented demonstrating the safety and
accuracy of the Eversense E3 CGM system.
“These data further bolster Eversense’s position as a leading
CGM choice for people with diabetes. These recent studies are an
important step forward as we continue to expand awareness of the
system’s unique clinical benefits,” said Francine Kaufman, M.D.,
Senseonics Chief Medical Officer. “We are thankful for the
opportunity to present these results to our peers at the American
Diabetes Association Scientific Sessions and are proud to support
the global diabetes community with a CGM that provides safety and
accuracy benefits that can lead to more effective diabetes
management.”
ADA Oral Presentation – Results for Accuracy Evaluation of an
Implantable CGM with Chemistry Improvements in a 365-Day
Feasibility Study presented by Lujain Al-Khawi
A feasibility study was conducted in 32 patients using a
modified Eversense CGM System to assess if longevity could be
extended through 365 days while maintaining accuracy.
The key findings were as follows:
- Sensor longevity was 97% through 365 days
- The sensor was safe with few minor skin irritation adverse
events
- MARD observed for the modified CGM system through 365 days was
similar to that observed with Eversense E3 CGM System through 180
days
The feasibility study of the next generation Eversense Sensor
showed the system could provide accurate performance through a
365-day period.
ADA Poster Presentation – Glycemic Improvements in CGM Naive
Patients during SMBG and Implantable CGM Use presented by Katherine
Tweden, PhD
In this multi-center study, CGM naive patients were followed for
6 months of self-monitoring of blood glucose (SMBG) followed by 6
months of Eversense CGM System use (90-day Eversense transitioning
to Eversense E3 CGM System after FDA approval). Changes in
glucometrics and HbA1c were evaluated. In the first 100 patients
who completed the study, the key results of the use of Eversense
CGM for 6 months were the following:
- While there was a decrease in HbA1c after 6 months of SMBG use,
there was a further significant reduction after 6 months of
Eversense CGM to a mean value of 6.93%
- CGM use resulted in a significant increase in time in range
(70-180 mg/dL) to a mean of 74.2%
- There were significant decreases in both time below range
(<70 mg/dL) and in times above range (>180 mg/dL and >250
mg/dL)
- 68% of patients achieved >70% TIR by the end of the CGM
phase
This study, reporting on 100 adult patients with diabetes,
showed that superior glucose outcomes were achieved with 6 months
use of Eversense CGM compared to the initial 6-month period where
management was achieved with SMBG only.
“We appreciate all the endocrinology key opinion leaders who
continue to investigate the real-world performance and benefits of
Eversense. This growing library of clinical evidence demonstrates
the value proposition of our system and supports the efforts of
Ascensia, our global commercial partner, to drive increased patient
and provider adoption,” said Tim Goodnow, PhD, President and Chief
Executive Officer for Senseonics.
About Eversense
The Eversense® E3 Continuous Glucose Monitoring (CGM) System is
indicated for continually measuring glucose levels in persons age
18 years and older with diabetes for up to 6 months. 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.
Eversense is marketed by Senseonics global commercial partner,
Ascensia Diabetes Care, which is a subsidiary of PHC Holdings
Corporation (TSE 6523). 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. (“Senseonics”) 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 statements about
expanding the benefits of Eversense to additional patients and
populations, statements regarding patient perceptions of the
benefits of Eversense, statements regarding user and provider
adoption of Eversense, statements regarding advancing development
programs, statements regarding regulatory submissions, 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 of Eversense® E3
CGM system and commercial expansion of the Eversense product,
uncertainties inherent in the transition of commercialization
responsibilities to Ascensia Diabetes Care and its commercial
initiatives, uncertainties inherent in collaborating with a new
partner in the Nurse Practitioner Group and that partner’s
assumption of certain clinical and administrative activities,
uncertainties in insurer, regulatory and administrative processes
and decisions, uncertainties in the duration and severity of the
COVID-19 pandemic, uncertainties inherent in the development and
registration of new technology, uncertainties relating to the
current economic environment, 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, 2022, as filed with the
SEC on March 16, 2023, the Company’s Quarterly Report on Form 10-Q
for the quarter ended March 31, 2023, as filed with the SEC on May
9, 2023, 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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INVESTOR CONTACT Philip Taylor Gilmartin Group
415-937-5406 investors@senseonics.com
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