New Clinical Data Demonstrating the Safety and Accuracy of Eversense through 365 Days Presented at the American Diabetes Association 83rd Scientific Sessions
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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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