Senseonics Holdings Inc (NYSEAMERICAN:SENS) is the biggest percentage gainer in the pre-market session on Friday after the news.
Market Action
As of 6:25, SENS stock soared 84 cents or 41% to $2.89. The stock has traded 2.54 million shares.
Senseonics Announces Results of the PROMISE Study Demonstrating Strong Accuracy of 180 Day CGM Sensor
- announced the results of the PROMISE Study evaluating the accuracy and safety of the next generation Eversense CGM System for up to 180 days with reduced calibrations. The data was presented by Satish Garg, MD, Professor of Medicine at the Barbara Davis Center of the University of Colorado, Denver, and the study group Principal Investigator (PI), as an oral presentation at the 14th Annual ATTD Meeting. Results were presented for both the primary sensor and for a secondary sensor with modified chemistry (referred to as the SBA sensor) in a subset of study participants.
- The percent sensor readings within 20 mg/dL or 20% of reference values (20/20% agreement rate) were as follows:
- Across the full 40-400 mg/dL range, the agreement rate was 92.9% for the primary sensor and 93.9% for the SBA sensor.
- In the hypoglycemic ranges of 40-60 mg/dL and 61-80 mg/dL, the agreement rates were 89.4% and 92.2% for the primary sensor and 96.5% and 96.8% for the SBA sensor, respectively.
“We are very pleased with the results of the PROMISE Study which demonstrate an excellent safety and accuracy profile for the 180-day sensor. This study was initiated December 2018 and we’re very grateful to the tireless Clinical Investigators and the devoted study subjects for participating in this important clinical trial,” said Tim Goodnow, PhD, President and CEO of Senseonics. “As we await hearing from the US and European regulatory agencies concerning our pre-market submissions of data from both the primary and the SBA sensors, we are pleased to continue to offer the Eversense CGM systems in both the US and Europe with our commercialization partner, Ascensia Diabetes Care.”