Senseonics (NYSE:SENS) announced today that the FDA approved its next-generation continuous glucose monitor system, which lasts up to half a year.
Germantown, Maryland–based Senseonics designed the Eversense E3, which includes proprietary sacrificial boronic acid (SBA) technology, to extend longevity to six months (180 days). Senseonics previously offered the system with a 90-day wear time.
Data presented in 2021 showed strong accuracy with the fully implantable, 180-day sensor. The next-generation platform matched performance levels compared to the 90-day version, but with calibration reduced to essentially once per day. One of the sensor’s tests produced a mean absolute relative difference (MARD) of 8.5%, representing high accuracy.
Eversense E3 features a third-generation sensor with SBA technology that enhances sensor longevity to make it what the company says is the longest-lasting CGM system. The sensor is fully implantable and requires just two sensor insertion and removal procedures per year, according to a news release.
“The Eversense E3 CGM system is an exciting advancement in diabetes management,” Senseonics CMO Dr. Francine Kaufman said in the release. “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.”
The system also includes a removable smart transmitter, held in place with a mild silicone-based adhesive, offering discreet, on-body vibratory alerts and data transmission to a mobile app where users can view glucose values, trends and alerts.
Senseonics plans to make the Eversense E3 CGM available to patients in the U.S. through its global commercial partner, Ascensia Diabetes Care, beginning in the second quarter of 2022.
“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,” Senseonics President and CEO Tim Goodnow said. “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.”
Following the delayed FDA reviewal process and the achievement of approval, Senseonics today also confirmed its 2022 financial outlook, projecting full-year revenues to range between $14 million and $18 million.
BTIG analyst Marie Thibault wrote in a report that Senseonics’ projection falls well short of the $30.7 million that Wall Street forecast, although that shortcoming is “understandable in light of the lengthy wait for FDA approval.”
Analysts were surprised by the company’s lack of meaningful net revenue growth in 2022 due to an anticipated sequential decline in the first quarter as Senseonics navigates through remaining inventory and the transition for payor contracts to begin covering the Eversense E3. They expect patients and prescribers to show heightened interest in Eversense E3, but the low revenue outlook “disguises this enthusiasm.”