Senseonics Receives FDA Approval for Glucose Monitoring System

Medical technology company Senseonics Holdings, Inc. (NYSE: SENS) recently announced that its glucose monitoring Eversense® E3 CGM System has received approval from the Food and Drug Administration (FDA).

However, shares of the company reacted adversely to the news and declined over 33.8% to close at $2.41 in Friday’s extended trading session.

The Eversense E3 is expected to be made available to patients in the U.S. through Ascensia Diabetes Care, Senseonics’ global commercial partner, beginning in the second quarter of 2022.

Strategic Impact

With the launch of this new glucose monitoring system, Senseonics will be able to offer patients a fully implantable third-generation sensor with proprietary SBA technology to enhance sensor longevity and enhanced sensor wear duration of 6 months.

Moreover, a removable smart transmitter will be made available for discreet on-body vibratory alerts and data transmission to a mobile app where glucose values, trends and alerts are displayed.

For 2022, the company expects to post revenues in the range of $14 million to $18 million.

Management Commentary

The CEO of Senseonics, Tim Goodnow, said, “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. 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.”

Stock Rating

Recently, Craig-Hallum analyst Alexander Nowak reiterated a Sell rating on the stock with a price target of $0.8, which implies downside potential of 67% from current levels.

According to the analyst, the company’s muted revenue guidance acts as a deterrent in terms of value creation for the company.

Consensus among analysts is a Hold based on 1 Buy, 1 Hold and 1 Sell. The average Senseonics stock prediction of $2.40 implies downside potential of 0.83% from current levels. Shares have declined 54.1% over the past year.

Hedge Funds’ Confidence

TipRanks’ Hedge Fund Trading Activity tool shows that hedge fund confidence in Senseonics is currently Positive. Moreover, the cumulative change in holdings across the three hedge funds that were active in the last quarter was an increase of 226,300 shares.

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