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Study results from a glucose monitoring company were reported after market close Thursday.
What Happened: Medical technology company Senseonics Holdings (NYSE:SENS) reported results from a PROMISE study evaluating its Eversense CGM System for up to 180 days. The Eversense CGM is a continuous glucose monitoring device.
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The overall mean absolute relative difference was 9.1% for the primary sensor and 8.5% for the SBA sensor. The study included over 49,000 paired points for the primary sensor and over 12,000 paired points for the SBA sensor.
The confirmed hypoglycemic alert detection rate was 93% for the primary sensor and 94% for the SBA sensor.
No serious negative events were reported from 181 study participants. A reported 1.1%% of patients had a mild infection at the procedure site.
Related Link: Senseonics Announces Business Update
Why It’s Important: Senseonics initiated the study in December 2018 and is awaiting hearing from the U.S. and European regulatory agencies for the primary and SBA sensors.
The study was the basis of a pre-market application submission to the U.S. FDA and to BSI for CE mark in Europe.
The company offers the Eversense CGM systems in the U.S. and Europe with commercial partner Ascensia Diabetes Care.
The approval of the 180-day monitoring device could help Senseonics compete in the CGM market dominated by Abbot Laboratories (NYSE:ABT) and DexCom Inc (NASDAQ:DXCM).
Price Action: Shares of Senseonics are up 30% to $2.66 in after-hours trading Thursday.
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New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.