Senseonics’ Eversense E3 CGM Earns FDA Approval

Senseonics today earned U.S. Food and Drug Administration (FDA) approval for the latest generation of its implantable continuous glucose monitor (CGM), the Eversense E3 CGM system. Eversense E3 includes proprietary boronic acid (SBA) tech to lengthen its longevity to six months. It’s planned to be available to U.S. patients through Ascensia Diabetes Care in the second quarter of this year.
 
“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” Satish Garg, M.D., Professor of Medicine and Director of the Adult Diabetes Program at the Barbara Davis Center of the University of Colorado, and the Principal Investigator of the PROMISE Study, which formed the basis for the FDA approval, told the press. “The next generation Eversense E3 System delivers on both. Patients will appreciate the excellent accuracy of the system and the ability of the sensor to last 6 months. This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.”
 
A six-month wear duration makes Eversense the longest lasting CGM system available. A removable smart transmitter is held in place with a mild silicone adhesive for on-body vibration alerts and data transmission to a mobile app to display metrics and alerts.
 
“Further extending the duration of the longest lasting CGM system to 6 months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community,” said Tim Goodnow, Ph.D., president and CEO of Senseonics. “The review was delayed by one year due to COVID-19 priorities and now together with our partner Ascensia, we can execute our launch plan to deliver the Eversense E3 CGM System to U.S. patients beginning in the second quarter. We look forward to initiating Eversense E3 sales and believe that, with Ascensia’s newly dedicated CGM commercial organization, the launch of the new 6-month product will establish the foundation for growth in our installed base later in 2022 and beyond.”
 
Senseonics expects last year’s revenue to be about $13.7 million, and 2022 revenue to be in the range of $14-18 million. The company aims to release fourth quarter and fiscal year 2021 results on March 1.
 
“The Eversense E3 CGM System is an exciting advancement in diabetes management,” said Francine Kaufman, MD, chief medical officer of Senseonics. “We believe patients and providers are waiting for this step forward. I want to take this opportunity to thank the PROMISE Study investigators, study participants, and the Senseonics team for helping us reach this important milestone, and the diligence of the FDA reviewers in this difficult environment. We are excited to begin making this next generation product available in the U.S. to people with diabetes.”