The Toronto-based company said it completed all procedures under Good Laboratory Practices guidelines for acute and chronic animal and human cadaver studies, with slated to follow by the end of August.
“We are pleased to have completed all of the planned GLP procedures necessary for our Investigational Device Exemption application to the U.S. Food & Drug Administration,” CEO David McNally said in prepared remarks. “Anticipating positive results from the chronic study, we subsequently plan to submit the IDE application to the FDA during the current quarter.”
McNally said the company pushed human factors studies that were planned for the second quarter into the third quarter, to get the GLP procedures completed.
“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,” he said.