Senseonics (NYSE:SENS) said yesterday that is presenting long-term safety data on its Eversense CGM from a European post-market clinical follow up registry later this week, touting that results showed the device as having a strong safety profile.
The presentation is slated to take place this Saturday as part of the American Diabetes Association’s Scientific Sessions in San Francisco, the Germantown, Md.-based company said.
The company touted that it believes the data from the study will show the safety of the system in a large patient population.
Senseonics’ 90-day, implantable CGM won FDA approval last June. The Eversense system includes a small sensor that is implanted just below the skin in an outpatient procedure. It continuously measures glucose levels, sending that data to a mobile app every five minutes and alerting users if their glucose levels drop out of range.
“We are pleased with the results of the European Eversense PMCF registry which demonstrate the safety of the Eversense CGM System in a large group of patients. This post-market study was an opportunity to evaluate the real-world experience of Eversense and Eversense XL CGM as patients wore their first, second, third and fourth sensors. The results, with 3,667 patient-years of wear, demonstrated a strong safety profile over repeat sensor cycles for the first long-term implantable sensor,” clinical sciences VP Katherine Tweden said in a press release.
Last month, Senseonics saw shares fall after the diabetes-focused device maker posted first-quarter results that missed the consensus forecast on Wall Street.