Focal, Inc.
This article was originally published in The Gray Sheet
Executive Summary
Receives FDA investigational device exemption clearance to begin clinical trials of the FocalSeal-S surgical sealant for cerebrospinal fluid (CSF) leaks. Preliminary results of a multi-center European study show 100% of patients effectively sealed with no unexpected safety events. Focal has an international distribution agreement with J&J subsidiary Ethicon but has retained all rights to the North American market. Over 1 mil. brain and spinal surgeries are performed worldwide each year in which CSF leaks may result