Continuous glucose monitoring system maker Senseonics has won FDA approval for its Eversense E3, which can be used to measure glucose levels in adults with diabetes for up to six months.

The system works using a sensor that is implanted just under the skin by a healthcare provider. A transmitter worn over the sensor, on top of the skin, receives glucose data, provides vibratory alerts and transmits information to a mobile app that can display trends and send alerts through the user's device.

The CGM is expected to be available to consumers through Ascensia Diabetes Care, Senseonics' commercialization and distribution partner, starting in the second quarter this year.

WHY IT MATTERS

Senseonics has been waiting a while for this approval. In December 2020, the company announced it had received word from the FDA that their application had been delayed due to the COVID-19 pandemic. 

The company is pitching the greenlight as a benefit for diabetes patients, who can now use the system for a longer period of time. 

"The Eversense E3 CGM System is an exciting advancement in diabetes management," said Dr. Francine Kaufman, chief medical officer of Senseonics, in a statement. "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 LARGER TREND

The Eversense system first received FDA approval in 2018 to be used for up to 90 days. In August 2020, Senseonics announced its deal with Ascensia Diabetes Care to manage distribution of the Eversense products for several years along with an investment in the CGM maker. 

In addition to the FDA approval, Senseonics also provided a financial update. It expects a 2022 net revenue from $14 million to $18 million, with most of its expenses going toward R&D and clinical trials for an expanded product pipeline.

Pending investigational device exemption approval from the FDA, it plans to begin a trial for a sensor that can be used for 365 days. 

The company also expects fourth quarter revenue of approximately $4 million, and about $13.7 million for the full year ended December 31. Senseonics will report its full fourth quarter and fiscal year results next month.