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US FDA Approves Eversense E3 CGM System, Allows Use for Up to 6 Months

Announced on February 11, the approval for Eversense E3 continuous glucose monitoring system allows access to a CGM system with 6 months of longevity and is expected to be available beginning in the second quarter of 2022.

The US Food and Drug Administration has approved the Eversense E3 Continuous Glucose Monitoring System, which uses proprietary sacrificial boronic acid (SBA) technology to extend longevity to 6 months, according to a press release from Senseonics.

The company noted plans for the Eversense E3 to be available to patients in the US through Ascensia Diabetes Care beginning in the second quarter of 2022.

“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” said Satish Garg, MD, 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, in the aforementioned release. “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.”

Announced on February 11, approval for Eversense E3 was based on the results of the PROMISE study. A prospective, multicenter trial assessing the effects of the m system in 181 participants with a 6-month follow-up, results of the trial demonstrated the mean absolute difference against the reference value of 9.1% for the primary sensor and 8.5% for the SBA sensor. Results also suggested a confirmed hypoglycemic alert detection rate was 93% for the primary sensor and 94% for the SBA sensor.

In the release, Senseonics outlined the Eversense E3 CGM System includes the fully implantable third-generation sensor with proprietary SBA technology to enhance sensor longevity and removable smart transmitter that provides on-body vibratory alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed.

“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, PhD, President and Chief Executive Officer 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 US 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.”