An Early Feasibility Study (EFS) for NCSI’s GATE™ system was approved by the U.S. Food and Drug Administration (FDA) on 22 November 2019 to evaluate the safety and short-term efficacy of the device. Data from the EFS is further intended to support expansion under a pivotal clinical trial. This approval is currently limited to 3 U.S. institutions and 15 U.S. subjects.

Approvals from Ethics Committees are progressing, and study enrollment will begin in early 2020.