The Toronto-based company said that the freeze is the culmination of engineering work based on feedback it received through extensive preclinical feasibility studies and an ongoing formative human factors study.
Titan Medical said that an assembly of systems for Good Laboratory Practices and Summative Human Factors studies is “well underway” and that it has begun procuring hardware for the production of systems for FDA investigational device exemption trials.
“Design freeze is a significant achievement for us, and we are delighted to reach this important inflection point within our stated timeframe. Thanks to the tremendous effort by our development team including our product development partners and valuable feedback by our surgeon KOLs, we now have what we consider to be a world-class, differentiated surgical robot. We look forward to conducting GLP and IDE studies this year, as we continue on track to file by year-end 2019 our 510(k) application with the FDA and our technical file for the CE mark in Europe,” CEO David McNally said in a press release.
The company said that software integration and advanced graphical user interface features will continue to be implemented on a rolling basis.
In January, Titan Medical said that it upgraded its Sport robotic surgical system in anticipation of applying for FDA and CE Mark clearances.