| Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
|---|
| Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
|---|
| Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
|---|
Study Data to Support FDA Submission for the first 365-day Continuous Glucose Monitoring System
Senseonics Holdings, Inc. (NYSE:SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the completion of the ENHANCE Pivotal Clinical Study adult cohort following the recently completed 365-day visit for the final study patient.
"We are pleased that all patients have completed the testing for the adult arm of the ENHANCE clinical study. Demonstration of safe and accurate performance of Eversense® for 365 days in this study would further validate its ability to facilitate more effective and longer-term management of diabetes. This represents a major milestone for Senseonics as we work towards offering the differentiated benefits of implantable CGM for one full year with just a single sensor," said Francine Kaufman, M.D., Chief Medical Officer of Senseonics. "We appreciate the efforts of the participating investigators and patients and look forward to analyzing the data, preparing the submission and working with the FDA with the goal to secure approval for the planned 365-day Eversense® system in the coming quarters."
The ENHANCE study is designed to evaluate the accuracy and safety of the Eversense system for one year. Over 165 adult subjects were inserted with Eversense systems in four centers across the United States. Enrollment for the 365-day sensor configuration was completed in September 2022. Data gathered in this study was also used to support the FDA submission for the integrated continuous glucose monitoring, iCGM, designation earlier in 2023. An investigational device exemption ("IDE") supplement was submitted and approved for expansion of the study to allow for pediatric patients 14 to 18 years of age and the first pediatric study participants were enrolled in Q2 2023.
Posted In: SENS
