Senseonics Announces Presentation of PROMISE Data at the American Diabetes Association 81st Scientific Sessions

Rhea-AI Summary

Senseonics Holdings, Inc. (NYSE American: SENS) presented new data from the PROMISE Study regarding its Eversense CGM System at the American Diabetes Association’s 81st Annual Scientific Sessions. The findings indicate that the next-generation device demonstrates safety and accuracy comparable to the current 90-day sensor with extended usage up to 180 days. Key metrics include a mean absolute relative difference (MARD) of 9.1% and high hypoglycemia alert detection rates. The Eversense system enhances user experience by offering discreet alerts and a rechargeable transmitter.

Positive

• Data demonstrates safety and accuracy matching the existing 90-day sensor.
• Extended usage duration of the next-generation system up to 180 days.
• MARD of 9.1% indicates improved accuracy for glucose monitoring.
• High hypoglycemia alert detection rates of 87% at 60 mg/dL and 93% at 70 mg/dL.

Negative

• None.

Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced further presentation of PROMISE Study data evaluating the next generation Eversense CGM System at the American Diabetes Association Virtual 81^st Annual Scientific Sessions.

The data evaluating the safety and accuracy of the next generation Eversense system was presented by Satish Garg, MD, Professor of Medicine at the Barbara Davis Center of the University of Colorado, Denver, and the PROMISE study group Principal Investigator (PI). The Company presented previously released information demonstrating performance matching that of the current 90-day sensor available in the United States, with reduced calibration, down to one per day, with duration extended to 180 days. Accuracy measurements discussed in the oral presentation include a mean absolute relative difference (MARD) of 9.1% for the primary sensor and confirmed hypoglycemia alert detection rates at 60 mg/dL of 87% and at 70 mg/dL of 93%. For the subset of 43 modified sensors (referred to as the SBA sensor), the MARD was 8.5% and the confirmed hypo alert detection rates at 60 mg/dL and 70 mg/dL were 90% and 94%, respectively.

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.

More information on the Eversense system is available at www.eversensediabetes.com and physicians, nurse practitioners or physician assistants interested in learning more about 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 in the US. 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.

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FAQ

What are the key findings from the PROMISE Study for SENS?

The PROMISE Study data show the next-generation Eversense CGM System offers a mean absolute relative difference (MARD) of 9.1% and high hypoglycemia alert rates.

How long can the Eversense CGM System be used?

The next-generation Eversense CGM System has an extended usage duration of up to 180 days.

What is the hypoglycemia alert detection rate for the Eversense system?

The Eversense system's hypoglycemia alert detection rates are 87% at 60 mg/dL and 93% at 70 mg/dL.

Who presented the data for the Eversense CGM System?

The data was presented by Satish Garg, MD, at the American Diabetes Association's 81st Annual Scientific Sessions.

What is the ticker symbol for Senseonics Holdings?

The ticker symbol for Senseonics Holdings is SENS.