ASCENSIA DIABETES CARE ANNOUNCES FDA APPROVAL OF THE EVERSENSE E3 CONTINUOUS
GLUCOSE MONITORING SYSTEM FOR USE FOR UP TO 6 MONTHS
Parsippany, United States
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.
1Garg 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
Notes for Editors
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://eversensediabetes.com/safety-info/
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.
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global company focused entirely on helping people with diabetes. Our mission is to empower those living with diabetes through innovative solutions that simplify and improve their lives.
We are home to the world-renowned CONTOUR® portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense® continuous glucose monitoring systems from Senseonics. These products combine advanced technology with user-friendly functionality to help people with diabetes manage their condition and make a positive difference to their lives. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.
Ascensia is a member of PHC Group and was established in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings Corporation (formerly Panasonic Healthcare). Ascensia products are sold in more than 125 countries. Ascensia has around 1,500 employees and operations in 31 countries.
For further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com
©2022 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.
For more media enquiries, please contact:
Tim Stamper, Timothy.Stamper@Ascensia.com