Will Senseonics’ Eversense XL CGM System Pass Muster With FDA?

Senseonics Holdings Inc. (SENS) has a regulatory catalyst to keep an eye on in the coming weeks.

The FDA review of the company’s Eversense 180-day CGM system, also known as Eversense XL CGM, is nearing completion and a decision regarding approval will be announced soon.

The Eversense CGM is a continuous glucose monitoring system consisting of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts.

In the U.S., only the Eversense 90-day CGM system is approved and marketed while in Europe, both the 90-day and 180-day Eversense products have received the CE Mark and are commercially available.

The 90-day Eversense CGM system features a fully implantable sensor that can be worn for up to 90 days while the 180-day Eversense CGM System features an implanted sensor with extended life of up to 180 days.

For full year 2021, the company continues to expect global net revenue to be in the middle of the revenue guidance range of $12.0 million to $15.0 million. Total revenue for full year 2020 was $4.9 million.

SENS has traded in a range of $0.83 to $5.56 in the last 1 year. The stock closed Wednesday’s trading at $2.68, down 2.55%.

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