Senseonics, in partnership with Ascensia Diabetes Care, has received FDA clearance for an innovative medical device, the Eversense 365, an implantable glucose sensor designed for a wear time of one year. This clearance marks a significant advancement as it allows the sensor to be worn for double the duration of Senseonics’ previous model. The Eversense 365 is a continuous glucose monitor (CGM) that is implanted under the skin and works in conjunction with a removable transmitter placed on top of the skin using adhesive. This device is suitable for adults who are managing either Type 1 or Type 2 diabetes.
The Eversense 365 system features an ‘integrated CGM’ designation, which signifies its compatibility for use as part of an automated insulin delivery system. In such systems, the CGM collaborates with an insulin pump to regulate insulin dispensation based on glucose readings provided by the CGM. Discussions are currently ongoing between Ascensia and various pump manufacturers to explore further integration and use of the Eversense 365 within these automated systems.
Senseonics CEO Tim Goodnow emphasized the significance of this new device, stating the clearance and subsequent launch of the yearlong sensor is poised to be a key driver of transformation for the company. The Eversense 365 is an upgrade over previous models, not only in terms of wear time but also in its maintenance requirements. Calibration, which is essential for ensuring the accuracy of glucose readings, is less frequent with this new device—required only once a week after an initial 14-day period. In contrast, Senseonics’ previous 180-day sensor required calibrations twice daily for the first 21 days and then daily thereafter.
The approval of Eversense 365 also sets it apart from many other CGM systems currently available on the market, which typically need to be worn for only 10 to 14 days before needing replacement. Ascensia, which has been the exclusive distributor of the Senseonics’ Eversense CGM systems since 2020, plans to launch the Eversense 365 in the fourth quarter of this year.
Although specific sales projections for the new sensor have not been disclosed, Senseonics has high hopes for the potential market impact of the Eversense 365. The company anticipates that this new product could help to double its sales and user base by the year 2025. This optimistic outlook comes in the context of Senseonics reporting $4.9 million in revenue during the second quarter of the year, with most of these earnings stemming from its sales to Ascensia.
The introduction of the Eversense 365 occurs amidst a competitive and rapidly evolving market landscape for CGMs. Several competitors, including major players like Dexcom and Abbott, have recently begun selling the first over-the-counter glucose sensors, broadening access and consumer choice in the market. Additionally, Roche has announced its intentions to launch its inaugural CGM system in Europe in the near future, further adding to the competitive dynamics within this market segment.
The advancement and clearance of the Eversense 365 represent a substantial step forward in diabetes management technology, promising enhanced ease of use and a longer duration of wear that could significantly benefit users by simplifying and improving their diabetes care regimen.
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