Titan Medical Inc. has announced that all procedures under Good Laboratory Practice (“GLP”) principles associated with the acute and chronic animal studies and human cadaver studies using its single-port robotic surgery system have been completed. The Company intends to announce the results of required follow-up to the chronic procedures by the end of August.
“We are pleased to have completed all of the planned GLP procedures necessary for our Investigational Device Exemption (“IDE”) application to the U.S. Food and Drug Administration (“FDA”),” said David McNally, Titan’s chief executive officer. “Anticipating positive results from the chronic study, we subsequently plan to submit the IDE application to the FDA during the current quarter. Meanwhile, we are proceeding with human factors studies that were previously planned for the second quarter and moved to the third quarter in order to accommodate the GLP procedures, which from a timing perspective, were our priority. All of this data, along with the confirmatory human data to be collected from studies under the IDE, is intended to support our planned 510(k) application for U.S. marketing clearance of our single-port robotic surgery system, and a concurrent application for the CE mark planned by year-end 2019.”