The Company further announced the clinical trial for the epidural instrument has reached an enrollment of 200 patients. The goal of the pivotal IDE clinical trial is to demonstrate the accuracy of the CompuFlo technology in identifying and confirming the epidural space location.
The interim analysis of the COMPASS Study clearly achieved the goal set by the FDA IDE Investigational Plan. The Issuer looks forward to expeditiously continuing its enrollment and completing its trial later this year.
Legal basis: § 3 subparagraph 1 of the Exhibit 3 to the Alternative Trading System Rules “Current and Periodical Information in the Alternative Trading System on the NewConnect Market"
Źródło:Komunikaty spółek (EBI)
