Senseonics Holdings, a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, has received Food and Drug Administration (FDA) approval of the Eversense E3 CGM System.
The Eversense E3, including proprietary sacrificial boronic acid (SBA) technology to extend longevity to six months, is planned to be available to patients in the U.S. through Ascensia Diabetes Care, Senseonics’ global commercial partner, beginning in the second quarter of 2022.
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 Study1, which formed the basis for the FDA approval, said: “We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate. 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 six 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.”
The Eversense E3 CGM System offers patients:
- An implantable third generation sensor, with proprietary SBA technology to enhance sensor longevity, demonstrating a mean absolute relative difference (MARD) of 8.5% in the PROMISE Study.
- Six-month sensor wear duration.
- Removable smart transmitter, held in place with a mild silicone-based adhesive, providing alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed.
Tim Goodnow, PhD, president and chief executive officer of Senseonics, said: “Further extending the duration of the longest lasting CGM system to six months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community. 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 organisation, the launch of the new six-month product will establish the foundation for growth in our installed base later in 2022 and beyond."
Francine Kaufman, chief medical officer of Senseonics, said: “The Eversense E3 CGM System is an exciting advancement in diabetes management. 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.”
