Patient Enrollment and Implantation Procedures Complete for FIGS-2 Trial
San Diego, CA – October 4, 2016 – GlySens Incorporated today announced the successful implantation of the twentieth human subject participating in the Function of Implanted Glucose Sensor 2 (FIGS-2) trial [Clinicaltrials.gov NCT02345967] for people with diabetes in the United States. The FIGS-2 study is a multi-center, long-term assessment of the Eclipse ICGM® Sensor. The twentieth participant is an important milestone for the company. “We believe the clinical data will further support our growing confidence in our positive safety profile while enabling our technical team to qualify the system software and complete product development” said Bill Markle, President and CEO of GlySens. The primary objective of the FIGS-2 trial is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.