ASCENSIA DIABETES CARE ANNOUNCES FDA APPROVAL OF THE EVERSENSE E3 CONTINUOUS GLUCOSE MONITORING SYSTEM FOR USE FOR UP TO 6 MONTHS

Rhea-AI Summary

Ascensia Diabetes Care announced FDA approval for the next-generation Eversense® E3 Continuous Glucose Monitoring (CGM) System, developed by Senseonics (NYSE American: SENS). This system boasts a sensor life of up to six months, significantly enhancing patient convenience with only two sensor insertions required annually. The E3 sensor demonstrates exceptional accuracy, with a mean absolute relative difference (MARD) of 8.5% from the PROMISE Study. The product aims to launch in the U.S. in Q2 2022, supported by programs to improve patient access and affordability.

Positive

• FDA approval received for Eversense E3 CGM System.
• Sensor lasts up to 6 months, reducing the need for frequent replacements.
• High accuracy with a MARD of 8.5% demonstrated in the PROMISE Study.
• Designed to enhance user experience with fewer calibrations required.

Negative

• None.

PARSIPPANY, N.J., Feb. 14, 2022 /PRNewswire/ -- Ascensia Diabetes Care, a global diabetes care company, announces that its partner Senseonics Holdings, Inc. (NYSE American: SENS) has received approval from the U.S. Food and Drug Administration (FDA) for the next-generation Eversense^® E3 Continuous Glucose Monitoring (CGM) System. Ascensia plans to make the Eversense E3 sensor, which can be used for up to 6 months, available to patients in the U.S. during the second quarter of 2022.

Robert Schumm, President at Ascensia Diabetes Care, said, "As the world's first and only long-term CGM System, Eversense is truly innovative and the prospect of using a single sensor for 6 months is a huge step forward for people with diabetes. Ensuring that as many people as possible have access to Eversense E3 is key for us and we'll be introducing a program to help users experience Eversense affordably as we work closely with payers on coverage. We look forward to rolling out this next-generation system through our dedicated CGM commercial team in the U.S. in the coming months, as we strive to improve the lives of people with diabetes everywhere."

Developed by Senseonics and brought to people with diabetes by Ascensia, the newly approved Eversense E3 CGM System, which includes a sacrificial boronic acid (SBA) design modification to enhance sensor survival, offers patients:

• The longest lasting CGM available, with 6-month sensor wear duration and essentially two sensor insertion and removal procedures per year
• Exceptional accuracy, with a mean absolute relative difference (MARD) of 8.5% demonstrated in the PROMISE Study¹ for the duration of sensor wear
• A fully implantable fluorescence-based sensor, with a removable smart transmitter* that provides discreet on-body vibratory alerts and transmits data to a mobile app
• Fewer calibrations, with primarily one calibration required per day after day 21 of use

"This next generation system delivers on the patient's desire for a CGM sensor that is both long-lasting and highly accurate," said Elaine Anderson, Head of Eversense CGM Business Unit at Ascensia Diabetes Care. "Its unique features and benefits offer people with diabetes unparalleled flexibility, convenience and accuracy. Our partner Senseonics has designed Eversense E3 with the user in mind and we are excited to bring the system to people in the U.S. in the second quarter."

To be among the first to know when Eversense E3 is commercially available, patients who are interested in getting started with Eversense now can sign up at www.eversensediabetes.com/get-started-today. Physicians, nurse practitioners and physician assistants who are interested in offering the Eversense CGM System can sign up at www.ascensiadiabetes.com/eversense/become-a-provider/register/. Alternatively, contact 844-SENSE4U (844-736-7348) to learn more about the first and only long-term implantable CGM system.

* There is no glucose data generated when the transmitter is removed.
¹ Garg S. 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 2021; 24(2): 1-9.DOI: 10.1089/dia.2021.0182

View original content:https://www.prnewswire.com/news-releases/ascensia-diabetes-care-announces-fda-approval-of-the-eversense-e3-continuous-glucose-monitoring-system-for-use-for-up-to-6-months-301481042.html

SOURCE Ascensia Diabetes Care

FAQ

What is the Eversense E3 Continuous Glucose Monitoring System?

The Eversense E3 is a next-generation CGM system approved by the FDA, featuring a sensor that lasts up to six months.

When will the Eversense E3 be available in the U.S.?

The Eversense E3 is expected to be available in the second quarter of 2022.

What are the benefits of the Eversense E3 System?

The Eversense E3 offers long sensor life, high accuracy, fewer calibrations, and a user-friendly design.

What is the significance of the MARD of 8.5% in the PROMISE Study?

A MARD of 8.5% indicates the Eversense E3's high accuracy in monitoring glucose levels for patients.

How is Ascensia supporting patient access to Eversense E3?

Ascensia plans to implement programs that help users access the Eversense E3 affordably while working with payers on coverage.